<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="120cfe40-e08a-4d33-9f90-023af39fdf8e"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <effectiveTime value="20220630"/>
   <setId root="ba40ef7d-566c-4589-9ceb-8d1bd9bbf5ef"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="619153559"/>
            <name>Huvepharma, Inc</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="552691651" root="1.3.6.1.4.1.519.1"/>
                  <name>Huvepharma EOOD</name>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="7f0b1ee0-c416-47d9-b2cf-a85269c7f22f"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20220630"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="23243-0120" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Flu-Nix</name>
                        <formCode code="C42945" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INJECTION, SOLUTION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>flunixin meglumine</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator value="50" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="8Y3JK0JW3U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FLUNIXIN MEGLUMINE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="356IB1O400" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FLUNIXIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="5" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="339NCG44TV" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>phenol</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="339NCG44TV" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PHENOL</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="100" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="23243-0120-4" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43210" displayName="VIAL, MULTI-DOSE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="200" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="23243-0120-5" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43210" displayName="VIAL, MULTI-DOSE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20150210"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="ANADA200061" root="2.16.840.1.113883.3.150"/>
                           <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38276" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INTRAVENOUS"/>
                        </substanceAdministration>
                     </consumedIn>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C28161" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="INTRAMUSCULAR"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="Lee93662e-4b27-44e0-8742-185442413762">
               <id root="ba7260fe-5c1f-4f4c-ac7b-1f675d1a5ffe"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Sterile NDC 23243-0120-4</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Flu-Nix™</content>
                     <br/>
                     <content styleCode="bold">(flunixin meglumine injection)</content>
                     <br/>
                     <content styleCode="bold">50 mg/mL</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L2fcb2f62-dc25-4d2f-a9f5-d0393d564475">
               <id root="c37d99e3-4ace-4d9e-b0a0-021cb4ea9753"/>
               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal law restricts this</content>
                     <br/>
                     <content styleCode="bold">drug to use by or on the order of a</content>
                     <br/>
                     <content styleCode="bold">licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-061</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS: 100 mL</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L7d7ab5ce-3cf9-48e6-b5ff-787438dfef2b">
               <id root="081719b2-bb8d-4177-aac7-9b8418945f7c"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>Only for Intravenous Use in Beef and Dairy Cattle.<br/>Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous<br/>and Intramuscular use in Horses.</paragraph>
                  <paragraph>
                     <br/>Before using this drug, read package outsert for complete<br/>product information.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L7b3e4d13-d06c-42c6-80a4-eb841ba7c5b8">
               <id root="35d71589-6b6d-481b-a0c3-c5124798104b"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>To report suspected adverse drug events, for technical<br/>assistance or to obtain a copy of the Safety Data Sheet (SDS),<br/>contact Huvepharma, Inc. at 1-877-994-4883 or<br/>www.huvepharma.us. For additional information about adverse<br/>drug experience reporting for animal drugs, contact FDA at<br/>1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2c11d3e5-2d4f-44ea-9f80-2452c7fa6e60"/>
                     <br/>®Registered trademark of Huvepharma, Inc.<br/>Manufactured for<br/>Huvepharma, Inc.                      Rev. 09-2021<br/>Peachtree City, GA 30269               F-2847-04</paragraph>
               </text>
               <effectiveTime value="20220708"/>
               <component>
                  <observationMedia ID="L2c11d3e5-2d4f-44ea-9f80-2452c7fa6e60">
                     <text>Take Time</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L6f4ccd49-93fb-4d12-8a20-4948c748b243">
               <id root="c61badff-f3c1-436f-857c-b0d2d4dece78"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>Cattle must not be slaughtered for human consumption within 4 days of<br/>the last treatment. Milk that has been taken during treatment and for 36<br/>hours after the last treatment must not be used for food. Not for use in<br/>dry dairy cows. A withdrawal period has not been established for this<br/>product in preruminating calves. Do not use in calves to be processed for<br/>veal. Do not use in horses intended for food. Approved only for intravenous<br/>administration in cattle. Intramuscular administration has resulted in<br/>violative residues in the edible tissues of cattle sent to slaughter.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="Lfb85ff0e-1de1-44e4-a3bc-6a81f7a44f9f">
               <id root="c25d680b-a3c8-4247-8a72-42648262fd5a"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Controlled</content>
                     <br/>
                     <content styleCode="bold">Room Temperature,</content>
                     <br/>
                     <content styleCode="bold">20º to 25º C (68º to</content>
                     <br/>
                     <content styleCode="bold">77º F) [See USP].</content>
                  </paragraph>
                  <paragraph>Lot No.:            Exp. Date:</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="La7ba8cfc-041d-4700-8be4-1c94aef48558">
               <id root="fc60c280-1ed8-40bb-abd7-8c1293172a0f"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Flu-Nix™</content>
                     <br/>
                     <content styleCode="bold">(flunixin meglumine injection)</content>
                     <br/>
                     <content styleCode="bold">50 mg/mL</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L5125f2a0-b919-4b9a-9f0f-8b3b106fba08">
               <id root="8c614cdd-cee6-48b3-9cf2-674621484882"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Only for Intravenous Use in Beef and Dairy Cattle.</content>
                     <br/>
                     <content styleCode="bold">Not for Use in Dry Dairy Cows and Veal Calves.</content>
                     <br/>
                     <content styleCode="bold">For Intravenous and Intramuscular Use in Horses.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L55362f4a-bf5e-47b9-8a00-b52819ac5f3d">
               <id root="e611b8c6-95fb-4834-a421-be157dac8d50"/>
               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Caution</content>
                     <br/>Federal law restricts this drug to use by or on the<br/>order of a licensed veterinarian.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L2677dd7c-5ac6-48fe-9a8d-7bd7b229a95e">
               <id root="cb0237dc-b48b-49a6-9e6c-c1fb1c7cd122"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Description</content>
                     <br/>Each milliliter of Flu-Nix™ (flunixin meglumine<br/>injection) contains flunixin meglumine equivalent<br/>to 50 mg flunixin, 0.1 mg edetate disodium, 2.5<br/>mg sodium formaldehyde sulfoxylate, 4.0 mg<br/>diethanolamine, 207.2 mg propylene glycol, 5.0<br/>mg phenol as preservative, hydrochloric acid,<br/>water for injection q.s.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L6cb93845-e313-47bd-bbd9-de4929720699">
               <id root="e3f63a81-b3ca-4020-a576-2ab7e5c604f0"/>
               <code code="34091-9" codeSystem="2.16.840.1.113883.6.1" displayName="ANIMAL PHARMACOLOGY &amp; OR TOXICOLOGY SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Pharmacology</content>
                     <br/>Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with<br/>anti-inflammatory and anti-pyretic activity. It is significantly more potent than pentazocine,<br/>meperidine and codeine as an analgesic in the rat yeast paw test.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as<br/>measured by the reduction in lameness and swelling in the horse. Plasma half-life in horse<br/>serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in<br/>horse plasma at 8 hours post injection.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> Flunixin meglumine is a weak acid (pKa=5.82)<sup>1</sup> which exhibits a high degree of<br/>plasma protein binding (approximately 99%).<sup>2</sup> However, free (unbound) drug appears to readily<br/>partition into body tissues (V<sub>ss</sub> predictions range from 297 to 782 mL/kg.<sup>2-5</sup> Total body water is<br/>approximately equal to 570 mL/kg).<sup>6</sup> In cattle, elimination occurs primarily through biliary<br/>excretion.<sup>7</sup> This may, at least in part, explain the presence of multiple peaks in the blood<br/>concentration/time profile following IV administration.<sup>2</sup>
                     <br/>In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.<sup>2-5</sup>
                     <br/>These studies also report a large discrepancy between the volume of distribution at a steady<br/>state (V<sub>ss</sub>) and the volume of distribution associated with the terminal elimination phase<br/>(V<sub>ß</sub>). This discrepancy appears to be attributable to extended drug elimination from a deep<br/>compartment.<sup>8</sup> The terminal half-life has been shown to vary from 3.14 to 8.12 hours.<sup>2-5</sup>
                     <br/>Flunixin persists in inflammatory tissues<sup>9</sup> and is associated with anti-inflammatory properties<br/>which extend well beyond the period associated with detectable plasma drug concentrations.<sup>4,9</sup>
                     <br/>These observations account for the counterclock-wise hysteresis associated with<br/>flunixin's pharmacokinetic/pharmacodynamic relationships.<sup>10</sup> Therefore, prediction of drug<br/>concentrations based upon the estimated plasma terminal elimination half-life will likely<br/>underestimate both the duration of drug action and the concentration of drug remaining at the<br/>site of activity.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lc4aceb17-44b7-4068-b556-88dc6d5bc8ec">
               <id root="afb7ad5c-d92c-4c37-b624-2ade983d863d"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Indications</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> Flu-Nix™ (flunixin meglumine injection) is recommended for the alleviation of<br/>inflammation and pain associated with musculoskeletal disorders in the horse. It is also<br/>recommended for the alleviation of visceral pain associated with colic in the horse.<br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Cattle: </content>
                     </content>Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated<br/>with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin<br/>meglumine injection) is also indicated for the control of inflammation in endotoxemia.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Ldb14e4d7-7927-4082-af27-ce4c54004120">
               <id root="57479844-cfef-4932-9af5-fbd671ef64bb"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dose and Administration</content>
                     <br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Horse:</content>
                     </content> The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1<br/>mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular<br/>injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak<br/>response occurs between 12 and 16 hours. Peak response occurs between 12 and 16 hours and<br/>duration of activity is 24-36 hours.<br/>The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound<br/>of body weight. Intravenous administration is recommended for prompt relief. Clinical studies<br/>show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when<br/>signs of colic recur. During clinical studies approximately 10% of the horses required one or<br/>two additional treatments. The cause of colic should be determined and treated with<br/>concomitant therapy.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> The recommended dose for control of pyrexia associated with bovine respiratory<br/>disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg<br/>(0.5 to 1 mg/lb;1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration<br/>either once a day as a single dose or divided into two doses administered at 12-hour intervals for<br/>up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight.<br/>Avoid rapid intravenous administration of the drug.<br/>The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body<br/>weight given once by intravenous administration.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L44d5cca0-48c2-467e-8dd9-dbd39a951f8f">
               <id root="e54fd0f3-ce73-4360-8769-82bb45472e77"/>
               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Contraindications</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> There are no known contraindications to this drug when used as directed. Intra-arterial<br/>injection should be avoided. Horses inadvertently injected intra-arterially can show adverse<br/>reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness.<br/>Signs are transient and disappear without antidotal medication within a few minutes. Do<br/>not use in horses showing hypersensitivity to flunixin meglumine.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> NSAIDS inhibit production of prostaglandins which are important in signaling<br/>the initiation of parturition. The use of flunixin can delay parturition and prolong labor which<br/>may increase the risk of stillbirth. Do not use Flu-Nix™ (flunixin meglumine injection) within 48<br/>hours of expected parturition.<br/>Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal<br/>impairment or gastric ulceration are suspected</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L7d7248f9-574d-461c-a24f-089c13b81d04">
               <id root="fb7c3875-837d-4268-b382-62a69744e0fc"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>Cattle must not be slaughtered for human consumption within 4 days of the last<br/>treatment. Milk that has been taken during treatment and for 36 hours after the last<br/>treatment must not be used for food. Not for use in dry dairy cows. A withdrawal period<br/>has not been established for this product in preruminating calves. Do not use in calves<br/>to be processed for veal. Do not use in horses intended for food. Approved only for<br/>intravenous administration in cattle. Intramuscular administration has resulted in<br/>violative residues in the edible tissues of cattle sent to slaughter.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L780b9d49-6400-4b46-bc95-dbc81512fb01">
               <id root="6a6acc49-eaaf-4d8d-95ef-80bf4ad29a5f"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Precautions</content>
                     <br/>As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal and renal<br/>toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients<br/>at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or<br/>those with renal, cardiovascular, and/or hepatic dysfunction.<br/>Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant<br/>use of Flunixin Meglumine Injection with other anti-inflammatory drugs, such as other NSAIDs<br/>and corticosteroids, should be avoided or closely monitored.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> The effect of Flunixin Meglumine Injection on pregnancy has not been determined.<br/>Studies to determine activity of Flunixin Meglumine Injection when administered<br/>concomitantly with other drugs have not been conducted. Drug compatibility should be monitored<br/>closely in patients requiring adjunctive therapy.<br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Cattle:</content>
                     </content> Do not use in bulls intended for breeding, as reproductive effects of Flunixin<br/>Meglumine Injection in these classes of cattle have not been investigated. NSAIDs are known to<br/>have potential effects on both parturition (See Contraindications) and the estrous cycle. There<br/>may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of<br/>the estrous cycle. NSAIDS are known to have the potential to delay parturition through a tocolytic<br/>effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine<br/>involution and expulsion of fetal membranes. Cows should be monitored carefully for placental<br/>retention and metritis if Flunixin Meglumine Injection is used within 24 hours after parturition.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L6e4bad5b-1591-4cc9-9dce-772f23c04d39">
               <id root="a8c896a3-f5f8-42e4-abda-f166b0943053"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Safety</content>
                     <br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Horse:</content>
                     </content> A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was<br/>safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous<br/>dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days<br/>produced no changes in blood or urine parameters. No injection site irritation was<br/>observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation<br/>was observed following a 3-fold dose administered intramuscularly.<br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Cattle:</content>
                     </content> No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X<br/>(2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal<br/>toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered<br/>daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria<br/>or fecal blood are observed.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lee5844ea-fcd0-4d5d-a792-99018754d367">
               <id root="885f3706-f54c-48b6-8daf-68ce5539d8dd"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Adverse Reactions</content>
                     <br/>In horses, isolated reports of local reactions following intramuscular injection, particularly in<br/>the neck, have been received. These include localized swelling, sweating, induration, and<br/>stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections<br/>have been reported in association with intramuscular use of Flunixin Meglumine<br/>Injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have<br/>been fatal, have been reported, primarily following intravenous use.<br/>To report suspected adverse drug events, for technical assistance or to obtain a copy of the<br/>Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us.<br/>For additional information about adverse drug experience reporting for animal drugs, contact<br/>FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L3ae49512-483b-4346-b069-01760aba3555">
               <id root="0f66b1e9-7d3d-49eb-8ab7-ccd62b0e9a16"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">How Supplied</content>
                     <br/>
                     <content styleCode="bold">Flu-Nix™ (flunixin meglumine injection),</content>
                     <br/>
                     <content styleCode="bold">50 mg/mL, is available in 100 mL and 250 mL</content>
                     <br/>
                     <content styleCode="bold">multi-dose vials.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L73d7178a-829d-4162-b2da-3765cb9d41aa">
               <id root="890bbd28-d758-42ad-9ff8-6d87a14db19f"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Controlled Room Temperature,</content>
                     <br/>
                     <content styleCode="bold">20º to 25º C (68º to 77º F) [See USP].</content>
                     <br/>When used as labeled, there is no limit on the<br/>number of punctures throughout the full expiry<br/>period.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L2fcade05-b2cf-4e17-a1ad-d2aefd81f265">
               <id root="49f38463-5b81-47f4-8ee5-14ef63c052ba"/>
               <code code="34093-5" codeSystem="2.16.840.1.113883.6.1" displayName="REFERENCES SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">REFERENCES</content>
                     <br/>1. Johansson M, Anler EL. Gas chromatographic<br/>analysis of flunixin in equine urine after<br/>extractive methylation. J Chromatogr.<br/>1988;427:55-66.<br/>2. Oldensvik K, Johansson M. High-performance<br/>liquid chromatography method for<br/>determination of flunixin in bovine plasma and<br/>pharmacokinetics after single and repeated<br/>doses of the drug. Am J Vet Res.<br/>1995;56:489-495.<br/>3. Anderson KL, Neff-Davis CA, Davis LE, Bass VD.<br/>Pharmacokinetics of flunixin meglumine in<br/>lactating cattle after single and multiple<br/>intramuscular and intravenous administrations.<br/>Am J Vet Res. 1990;51:1464-1467.<br/>4. Oldensvik K. Pharmacokinetics of flunixin and<br/>its effect on prostaglandin F2a metabolite<br/>concentrations after oral and intravenous<br/>administration in heifers. J Vet Pharmacol Ther.<br/>1995;18:254-259.<br/>5. Hardee GE, Smith JA, Harris SJ.<br/>Pharmacokinetics of flunixin meglumine in the<br/>cow. Res Vet Sci. 1985;39:110-112.<br/>6. Ruckebusch Y, Phaneuf LP, Dunlop R. Physiology<br/>of Small and Large Animals. Chapter 2; "Body<br/>Fluid Compartments," Philadelphia, Pa: B.C.<br/>Decker; 1991:8-18.<br/>7. Kopcha M, Ahi AS. Experimental use of flunixin<br/>meglumine and phenylbutazone in<br/>food-producing animals. J Am Vet<br/>Med Assoc. 1989;194:45-49.<br/>8. Wagner JG. Significance of ratios of different<br/>volumes of distribution in pharmacokinetics.<br/>Biopharm &amp; Drug Dispos. 1983;4:263-270.<br/>9. Lees P, Higgins AJ. Flunixin inhibits<br/>prostaglandin E2 production in equine<br/>inflammation. Res Vet Sci. 1984;37:347-349.<br/>10. Landoni MF, Cunningham FM, Lees P.<br/>Determination of pharmacokinetics and<br/>pharmacodynamics of flunixin in calves by<br/>use of pharmacokinetic/ pharmacodynamic<br/>modeling. Am J Vet Res. 1995;56:786-794.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L36bc8747-44ac-4753-8b4d-c37dabf6d0d1">
               <id root="f7e3c181-92ba-461a-a77d-dc9c175f1be9"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>Only for Intravenous use in Beef and Dairy Cattle.<br/>Not for Use in Dry Dairy Cows and Veal Calves. For<br/>Intravenous and Intramuscular Use in Horses.<br/>Read accompanying directions for use.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L4844c48b-2643-43ee-89c9-f35aaee0940c"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-061</content>
                     <br/>
                     <content styleCode="bold">®Registered trademark of Huvepharma, Inc.</content>
                     <br/>
                     <content styleCode="bold">Manufactured for</content>
                     <br/>
                     <content styleCode="bold">Huvepharma, Inc.</content>
                     <br/>
                     <content styleCode="bold">Peachtree City, GA 30269</content>
                     <br/>
                     <content styleCode="bold">Rev. 05-2022                      F-2847-05</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220708"/>
               <component>
                  <observationMedia ID="L4844c48b-2643-43ee-89c9-f35aaee0940c">
                     <text>Take Time 1</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time 1.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="Ld237ac90-3a46-4fec-abb0-5077978bf38a">
               <id root="211692a6-284c-4e10-b34c-2b26cc6aa330"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Sterile NDC 23243-0120-5</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Flu-Nix™</content>
                     <br/>
                     <content styleCode="bold">(flunixin meglumine injection)</content>
                     <br/>
                     <content styleCode="bold">50 mg/mL</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L67cbcc3a-cf20-409a-bab2-46b159b9c33a">
               <id root="abe5d56f-5cd5-4009-a796-060051c8a77e"/>
               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal law restricts this</content>
                     <br/>
                     <content styleCode="bold">drug to use by or on the order of a</content>
                     <br/>
                     <content styleCode="bold">licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-061</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS: 250 mL</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L4574f30c-3f5e-4f54-ae0f-191d394c7f31">
               <id root="fcd2d51d-83c7-4d58-b623-cfed5fde432a"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>Only for Intravenous Use in Beef and Dairy Cattle.<br/>Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous<br/>and Intramuscular use in Horses.</paragraph>
                  <paragraph>Before using this drug, read package outsert for complete<br/>product information.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="Ld3412149-eb0d-4a55-8442-a076dc4a58bf">
               <id root="86766433-c59e-410c-a399-96d6994f2114"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>To report suspected adverse drug events, for technical<br/>assistance or to obtain a copy of the Safety Data Sheet (SDS),<br/>contact Huvepharma, Inc. at 1-877-994-4883 or<br/>www.huvepharma.us. For additional information about adverse<br/>drug experience reporting for animal drugs, contact FDA at<br/>1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L875646d4-45a6-4e3f-9d4e-ff6ec532fae1"/>
                  </paragraph>
                  <paragraph>®Registered trademark of Huvepharma, Inc.<br/>Manufactured for<br/>Huvepharma, Inc.<br/>Peachtree City, GA 30269</paragraph>
                  <paragraph>Rev. 09-2021<br/>F-2847-05</paragraph>
               </text>
               <effectiveTime value="20220708"/>
               <component>
                  <observationMedia ID="L875646d4-45a6-4e3f-9d4e-ff6ec532fae1">
                     <text>Take Time</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time 2.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L8718e83e-0e00-48f5-b69d-08ea6ce6bdc8">
               <id root="309d6f12-6915-49c8-bab1-6bd1db55b365"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>Cattle must not be slaughtered for human consumption within 4 days of<br/>the last treatment. Milk that has been taken during treatment and for 36<br/>hours after the last treatment must not be used for food. Not for use in<br/>dry dairy cows. A withdrawal period has not been established for this<br/>product in preruminating calves. Do not use in calves to be processed for<br/>veal. Do not use in horses intended for food. Approved only for intravenous<br/>administration in cattle. Intramuscular administration has resulted in<br/>violative residues in the edible tissues of cattle sent to slaughter.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L8b05099b-edcc-49a8-9401-98ca10b7c8cc">
               <id root="14eb9348-851c-4aad-930b-fe279cfc8a6b"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Controlled</content>
                     <br/>
                     <content styleCode="bold">Room Temperature,</content>
                     <br/>
                     <content styleCode="bold">20º to 25º C (68º to</content>
                     <br/>
                     <content styleCode="bold">77º F) [See USP].</content>
                  </paragraph>
                  <paragraph>Lot No.:          Exp. Date:</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lf223053b-a538-4b92-af13-7c67798b57d1">
               <id root="f8cfb024-ca49-4ecd-b6e8-fa6a13ab50a2"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Flu-Nix™</content>
                     <br/>
                     <content styleCode="bold">(flunixin meglumine injection)</content>
                     <br/>
                     <content styleCode="bold">50 mg/mL Multiple-Dose Vial</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L14fd9328-d105-4132-bb93-01af752d9953">
               <id root="355335c1-0d58-49e8-9e92-a1447e472527"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>Only for Intravenous Use in Beef and Dairy Cattle.<br/>Not for Use in Dry Dairy Cows and Veal Calves.<br/>For Intravenous and Intramuscular Use in Horses.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="Laeb182b8-b0a8-4fa6-82d1-8ba3be128ea4">
               <id root="3a66de9e-bc36-4498-9dc9-a9940f81400f"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Caution</content>
                     <br/>Federal law restricts this drug to use by or on the<br/>order of a licensed veterinarian.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="La99cd110-a717-4a18-8cd7-51a9e4f1ed4c">
               <id root="81d59ced-e87b-47a8-9e91-e9734db2d81c"/>
               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Description</content>
                     <br/>Each milliliter of Flu-Nix™ (flunixin meglumine injection)<br/>contains flunixin meglumine equivalent to 50 mg flunixin,<br/>0.1 mg edetate disodium, 2.5 mg sodium formaldehyde<br/>sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene<br/>glycol, 5.0 mg phenol as preservative, hydrochloric acid,<br/>water for injection q.s.</paragraph>
               </text>
               <effectiveTime value="20220630"/>
            </section>
         </component>
         <component>
            <section ID="L164b54d7-70d4-4409-b725-537bc46ca4e1">
               <id root="2ad4df8e-9649-4dab-8da6-74baf2b26710"/>
               <code code="34091-9" codeSystem="2.16.840.1.113883.6.1" displayName="ANIMAL PHARMACOLOGY &amp; OR TOXICOLOGY SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Pharmacology</content>
                     <br/>Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with<br/>anti-inflammatory and anti-pyretic activity. It is significantly more potent than pentazocine,<br/>meperidine and codeine as an analgesic in the rat yeast paw test.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as<br/>measured by the reduction in lameness and swelling in the horse. Plasma half-life in horse<br/>serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in<br/>horse plasma at 8 hours post injection.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> Flunixin meglumine is a weak acid (pKa=5.82)<sup>1</sup> which exhibits a high degree of<br/>plasma protein binding (approximately 99%).<sup>2</sup> However, free (unbound) drug appears to readily<br/>partition into body tissues (V<sub>ss</sub> predictions range from 297 to 782 mL/kg.<sup>2-5</sup> Total body water is<br/>approximately equal to 570 mL/kg).<sup>6</sup> In cattle, elimination occurs primarily through biliary<br/>excretion.<sup>7</sup> This may, at least in part, explain the presence of multiple peaks in the blood<br/>concentration/time profile following IV administration.<sup>2</sup>
                     <br/>In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.<sup>2-5</sup>
                     <br/>These studies also report a large discrepancy between the volume of distribution at a steady<br/>state (V<sub>ss</sub>) and the volume of distribution associated with the terminal elimination phase<br/>(V<sub>ß</sub>). This discrepancy appears to be attributable to extended drug elimination from a deep<br/>compartment.<sup>8</sup> The terminal half-life has been shown to vary from 3.14 to 8.12 hours.<sup>2-5</sup>
                     <br/>Flunixin persists in inflammatory tissues<sup>9</sup> and is associated with anti-inflammatory properties<br/>which extend well beyond the period associated with detectable plasma drug concentrations.<sup>4,9</sup>
                     <br/>These observations account for the counterclock-wise hysteresis associated with<br/>flunixin's pharmacokinetic/pharmacodynamic relationships.<sup>10</sup> Therefore, prediction of drug<br/>concentrations based upon the estimated plasma terminal elimination half-life will likely<br/>underestimate both the duration of drug action and the concentration of drug remaining at the<br/>site of activity.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lc659f115-068b-431e-84d9-e5429f48534e">
               <id root="815a26ac-629c-413a-a6c7-01530010ee38"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Indications</content>
                     <br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Horse:</content>
                     </content> Flu-Nix™ (flunixin meglumine injection) is recommended for the alleviation of<br/>inflammation and pain associated with musculoskeletal disorders in the horse. It is also<br/>recommended for the alleviation of visceral pain associated with colic in the horse.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated<br/>with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin<br/>meglumine injection) is also indicated for the control of inflammation in endotoxemia.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lb023d97d-ed60-435d-89f4-6d373384183d">
               <id root="0d03d6e4-022e-49f9-83d3-1cee67802f45"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dose and Administration</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1<br/>mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular<br/>injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak<br/>response occurs between 12 and 16 hours. Peak response occurs between 12 and 16 hours and<br/>duration of activity is 24-36 hours.<br/>The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound<br/>of body weight. Intravenous administration is recommended for prompt relief. Clinical studies<br/>show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when<br/>signs of colic recur. During clinical studies approximately 10% of the horses required one or<br/>two additional treatments. The cause of colic should be determined and treated with<br/>concomitant therapy.<br/>
                     <content styleCode="bold">
                        <content styleCode="italics">   Cattle:</content>
                     </content> The recommended dose for control of pyrexia associated with bovine respiratory<br/>disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg<br/>(0.5 to 1 mg/lb;1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration<br/>either once a day as a single dose or divided into two doses administered at 12-hour intervals for<br/>up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight.<br/>Avoid rapid intravenous administration of the drug.<br/>The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body<br/>weight given once by intravenous administration.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lbefcd9c9-fd65-46c2-9415-ce8241e22e27">
               <id root="a7cc5dec-8a69-4bbc-895d-f5166f42a74e"/>
               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Contraindications</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> There are no known contraindications to this drug when used as directed. Intra-arterial<br/>injection should be avoided. Horses inadvertently injected intra-arterially can show adverse<br/>reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness.<br/>Signs are transient and disappear without antidotal medication within a few minutes. Do<br/>not use in horses showing hypersensitivity to flunixin meglumine.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> NSAIDS inhibit production of prostaglandins which are important in signaling<br/>the initiation of parturition. The use of flunixin can delay parturition and prolong labor which<br/>may increase the risk of stillbirth. Do not use Flu-Nix™ (flunixin meglumine injection) within 48<br/>hours of expected parturition.<br/>Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal<br/>impairment or gastric ulceration are suspected</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L8925e1ef-c98c-46a1-943f-5005f583c834">
               <id root="24102af2-ac4e-4b6c-a68c-dd683b02f509"/>
               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>Cattle must not be slaughtered for human consumption within 4 days of the last<br/>treatment. Milk that has been taken during treatment and for 36 hours after the last<br/>treatment must not be used for food. Not for use in dry dairy cows. A withdrawal period<br/>has not been established for this product in preruminating calves. Do not use in calves<br/>to be processed for veal. Do not use in horses intended for food. Approved only for<br/>intravenous administration in cattle. Intramuscular administration has resulted in<br/>violative residues in the edible tissues of cattle sent to slaughter.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lbf85f582-adce-4bec-a6d3-26f2f2f55d94">
               <id root="5406edf5-cfb1-41c5-bc85-0f158fc1bb16"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Precautions</content>
                     <br/>As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal and renal<br/>toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients<br/>at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or<br/>those with renal, cardiovascular, and/or hepatic dysfunction.<br/>Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant<br/>use of Flunixin Meglumine Injection with other anti-inflammatory drugs, such as other NSAIDs<br/>and corticosteroids, should be avoided or closely monitored.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> The effect of Flunixin Meglumine Injection on pregnancy has not been determined.<br/>Studies to determine activity of Flunixin Meglumine Injection when administered<br/>concomitantly with other drugs have not been conducted. Drug compatibility should be monitored<br/>closely in patients requiring adjunctive therapy.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> Do not use in bulls intended for breeding, as reproductive effects of Flunixin<br/>Meglumine Injection in these classes of cattle have not been investigated. NSAIDs are known to<br/>have potential effects on both parturition (See Contraindications) and the estrous cycle. There<br/>may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of<br/>the estrous cycle. NSAIDS are known to have the potential to delay parturition through a tocolytic<br/>effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine<br/>involution and expulsion of fetal membranes. Cows should be monitored carefully for placental<br/>retention and metritis if Flunixin Meglumine Injection is used within 24 hours after parturition.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L831623bb-902d-47dd-8cad-d45d7a44a40d">
               <id root="52983af4-3ced-4c6a-8e06-851377fe60d2"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Safety</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Horse:</content>
                     </content> A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was<br/>safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous<br/>dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days<br/>produced no changes in blood or urine parameters. No injection site irritation was<br/>observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation<br/>was observed following a 3-fold dose administered intramuscularly.<br/>
                     <content styleCode="italics">
                        <content styleCode="bold">   Cattle:</content>
                     </content> No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X<br/>(2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal<br/>toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered<br/>daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria<br/>or fecal blood are observed.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lf82beb65-5147-40ec-9780-f1334bc4d26c">
               <id root="1d5f06a8-d752-4674-ab15-4608d008957e"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Adverse Reactions</content>
                     <br/>In horses, isolated reports of local reactions following intramuscular injection, particularly in<br/>the neck, have been received. These include localized swelling, sweating, induration, and<br/>stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections<br/>have been reported in association with intramuscular use of Flunixin Meglumine<br/>Injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have<br/>been fatal, have been reported, primarily following intravenous use.<br/>To report suspected adverse drug events, for technical assistance or to obtain a copy of the<br/>Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us.<br/>For additional information about adverse drug experience reporting for animal drugs, contact<br/>FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L6ea3d43a-6398-4d1c-8a63-833299b60bc3">
               <id root="0f27ce93-4cc0-405f-96d7-a57520074a57"/>
               <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">How Supplied</content>
                     <br/>Flu-Nix™ (flunixin meglumine injection),<br/>50 mg/mL, is available in 100 mL and 250 mL<br/>multi-dose vials.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L85b0921b-7ae6-4ea0-93ae-8e6793511a39">
               <id root="2ddc6311-8092-4fb8-a879-b3b176fc2425"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Controlled Room Temperature,</content>
                     <br/>
                     <content styleCode="bold">20º to 25º C (68º to 77º F) [See USP].</content>
                     <br/>When used as labeled, there is no limit on the<br/>number of punctures throughout the full expiry<br/>period.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="L25ba11be-175e-441a-89e4-dc5683b7903b">
               <id root="a778db25-e2b6-436d-ba2d-c00745224eed"/>
               <code code="34093-5" codeSystem="2.16.840.1.113883.6.1" displayName="REFERENCES SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">REFERENCES</content>
                     <br/>1. Johansson M, Anler EL. Gas chromatographic<br/>analysis of flunixin in equine urine after<br/>extractive methylation. J Chromatogr.<br/>1988;427:55-66.<br/>2. Oldensvik K, Johansson M. High-performance<br/>liquid chromatography method for<br/>determination of flunixin in bovine plasma and<br/>pharmacokinetics after single and repeated<br/>doses of the drug. Am J Vet Res.<br/>1995;56:489-495.<br/>3. Anderson KL, Neff-Davis CA, Davis LE, Bass VD.<br/>Pharmacokinetics of flunixin meglumine in<br/>lactating cattle after single and multiple<br/>intramuscular and intravenous administrations.<br/>Am J Vet Res. 1990;51:1464-1467.<br/>4. Oldensvik K. Pharmacokinetics of flunixin and<br/>its effect on prostaglandin F2a metabolite<br/>concentrations after oral and intravenous<br/>administration in heifers. J Vet Pharmacol Ther.<br/>1995;18:254-259.<br/>5. Hardee GE, Smith JA, Harris SJ.<br/>Pharmacokinetics of flunixin meglumine in the<br/>cow. Res Vet Sci. 1985;39:110-112.<br/>6. Ruckebusch Y, Phaneuf LP, Dunlop R. Physiology<br/>of Small and Large Animals. Chapter 2; "Body<br/>Fluid Compartments," Philadelphia, Pa: B.C.<br/>Decker; 1991:8-18.<br/>7. Kopcha M, Ahi AS. Experimental use of flunixin<br/>meglumine and phenylbutazone in<br/>food-producing animals. J Am Vet<br/>Med Assoc. 1989;194:45-49.<br/>8. Wagner JG. Significance of ratios of different<br/>volumes of distribution in pharmacokinetics.<br/>Biopharm &amp; Drug Dispos. 1983;4:263-270.<br/>9. Lees P, Higgins AJ. Flunixin inhibits<br/>prostaglandin E2 production in equine<br/>inflammation. Res Vet Sci. 1984;37:347-349.<br/>10. Landoni MF, Cunningham FM, Lees P.<br/>Determination of pharmacokinetics and<br/>pharmacodynamics of flunixin incalves by<br/>use of pharmacokinetic/ pharmacodynamic<br/>modeling. Am J Vet Res. 1995;56:786-794.</paragraph>
               </text>
               <effectiveTime value="20220708"/>
            </section>
         </component>
         <component>
            <section ID="Lb188b75e-20e7-4d81-9220-dac589d197bd">
               <id root="9dd8913a-5ef7-4b69-9ffc-ddcb149ed1d6"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>Only for Intravenous use in Beef and Dairy Cattle.<br/>Not for Use in Dry Dairy Cows and Veal Calves. For<br/>Intravenous and Intramuscular Use in Horses.<br/>Read accompanying directions for use.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lb391a15f-239b-48f4-9743-3102abc8e928"/>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-061<br/>®Registered trademark of Huvepharma, Inc.</paragraph>
                  <paragraph>Manufactured for<br/>Huvepharma, Inc.<br/>Peachtree City, GA 30269</paragraph>
                  <paragraph>Rev. 05-2022                            F-2847-06</paragraph>
               </text>
               <effectiveTime value="20220708"/>
               <component>
                  <observationMedia ID="Lb391a15f-239b-48f4-9743-3102abc8e928">
                     <text>Take Time</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time 3.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="Le31f8bbb-b3f6-4803-a01d-aeb87635c0fc">
               <id root="5b8f7670-fa1d-4f2b-98f5-47bd8a84d52c"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L7170b0c7-d6c4-40bb-acca-eff6f0cda3cb"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Leb7a0f12-0297-422b-86b5-ac70afbcdffa"/>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2c154f71-8f7b-4d27-94b3-b1c969ae3647"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L3f7e5522-c77f-4cec-ac35-ee29f15589cb"/>
                  </paragraph>
               </text>
               <effectiveTime value="20220708"/>
               <component>
                  <observationMedia ID="L7170b0c7-d6c4-40bb-acca-eff6f0cda3cb">
                     <text>100 mL Bottle</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="FluNix 100ml bottle_09-2021_.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Leb7a0f12-0297-422b-86b5-ac70afbcdffa">
                     <text>100 mL Onsert</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="FluNix 100ml Onsert_05-2022.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L2c154f71-8f7b-4d27-94b3-b1c969ae3647">
                     <text>250 mL Bottle</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="FluNix 250ml bottle_09-2021_.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L3f7e5522-c77f-4cec-ac35-ee29f15589cb">
                     <text>250 mL Onsert</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="FluNix 250ml Onsert_05-2022.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>