<?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="192a8f59-53c5-4fbd-9543-3a96649506c6"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <title>panacur<sup>®</sup>
      <br/> (fenbendazole) <br/> Horse &amp; Cattle Dewormer</title>
   <effectiveTime value="20241115"/>
   <setId root="859d4e30-d70c-4baf-aa62-0d3feff25057"/>
   <versionNumber value="6"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="001317601" root="1.3.6.1.4.1.519.1"/>
            <name>Merck Sharp &amp; Dohme Corp.</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="771867553" root="1.3.6.1.4.1.519.1"/>
                        <name>Intervet Production S.A.</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C25391" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANALYSIS"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="420823163" root="1.3.6.1.4.1.519.1"/>
                        <name>Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="API MANUFACTURE"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="DLDE">
               <id root="57bcb98f-bca6-4274-8351-b97237fcfac9"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20241115"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="57926-087" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Panacur</name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Fenbendazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Fenbendazole</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>Fenbendazole</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="A2I8C7HI9T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>methylparaben</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="Z8IX2SC1OH" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>propylparaben</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>silicon dioxide</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="K679OBS311" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONE, UNSPECIFIED</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="B22547B95K" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>trisodium citrate dihydrate</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="2968PHW8QP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>citric acid monohydrate</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>water</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="1000" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="57926-087-01" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA128620" root="2.16.840.1.113883.3.150"/>
                           <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="19771115"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section>
               <id root="a55aa292-7c74-4c92-b4c8-1fc99a586550"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>INDICATIONS AND DOSAGE:</title>
               <effectiveTime value="20241115"/>
               <component>
                  <section>
                     <id root="8f862bd0-05d8-486a-9083-b6916b7e8c81"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Horses –</content> 2.3 mg/lb (5 mg/kg): for the treatment and control of large strongyles (<content styleCode="italics">Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus</content> spp.), small strongyles (<content styleCode="italics">Cyathostomum</content> spp., <content styleCode="italics">Cylicocyclus</content> spp., <content styleCode="italics">Cylicostephanus</content> spp., <content styleCode="italics">Cylicodontophorus</content> spp.), and pinworms (<content styleCode="italics">Oxyuris equi</content>). 4.6 mg/lb (10 mg/kg): for the treatment and control of ascarids (<content styleCode="italics">Parascaris equorum</content>)<content styleCode="italics">.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20241115"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="31a87735-1fe9-4cd2-a427-855a8cb1ea91"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Beef and Dairy Cattle –</content> 2.3 mg/lb (5 mg/kg): for the treatment and control of: <content styleCode="bold">Lungworms:</content> Adult <content styleCode="italics">Dictyocaulus viviparus</content>; <content styleCode="bold">Stomach worms:</content> Adult brown stomach worms (<content styleCode="italics">Ostertagia ostertagi</content>), Adult and fourth stage larvae barberpole worms (<content styleCode="italics">Haemonchus contortus</content> &amp; <content styleCode="italics">H. placei</content>) and Adult and fourth stage larvae small stomach worms (<content styleCode="italics">Trichostrongylus axei</content>); <content styleCode="bold">Intestinal worms</content> (Adult and fourth stage larvae): hookworms (<content styleCode="italics">Bunostomum phlebotomum</content>), thread-necked intestinal worms (<content styleCode="italics">Nematodirus helvetianus</content>), small intestinal worms (<content styleCode="italics">Cooperia punctata</content> &amp; <content styleCode="italics">C. oncophora</content>), bankrupt worms (<content styleCode="italics">Trichostrongylus colubriformis</content>), and nodular worms (<content styleCode="italics">Oesophagostomum radiatum</content>)<content styleCode="italics">.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20241115"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a57c09d9-aa6c-4dcd-828e-4de79bd0504b"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Beef Cattle Only –</content> 4.6 mg/lb (10 mg/kg): for the treatment and control of: <content styleCode="bold">Stomach worms</content> (4th stage inhibited larvae): <content styleCode="italics">Ostertagia ostertagi</content> (Type II Ostertagiasis); <content styleCode="bold">Tapeworms:</content>
                           <content styleCode="italics"> Moniezia benedeni.</content>
                        </paragraph>
                        <paragraph>
                           <content styleCode="bold">Do not use in dairy cattle at 10 mg/kg.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20241115"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="f1ab1858-273b-4815-8a43-d9d2ed222abd"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Shake well before use.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Store at or below 25°C (77°F)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Protect from freezing.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="cf4cc049-fd2d-43de-b9a5-6e1d9cbff559"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS:</title>
               <effectiveTime value="20241115"/>
               <component>
                  <section>
                     <id root="29eaa7cc-3592-44c5-81e5-27e4225629c9"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Horses and Beef and Dairy Cattle:</title>
                     <text>
                        <paragraph>Administer orally by suitable dosing syringe. Insert nozzle of syringe through the interdental space and deposit the drug on the back of the tongue by depressing the plunger. The drug may also be administered by stomach tube.</paragraph>
                        <paragraph>
                           <content styleCode="bold">EXAMPLES:</content>
                        </paragraph>
                        <table width="40%">
                           <col width="33%" align="left" valign="middle"/>
                           <col width="33%" align="left" valign="middle"/>
                           <col width="34%" align="left" valign="middle"/>
                           <thead>
                              <tr>
                                 <th>Animal Weight</th>
                                 <th>Dose<br/>(5 mg/kg)</th>
                                 <th>Dose<br/>(10 mg/kg)</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>
                                    <content styleCode="bold">100 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">2.3 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">4.6 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">200 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">4.6 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">9.2 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">300 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">6.9 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">13.8 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">400 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">9.2 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">18.4 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">500 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">11.5 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">23.0 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">1000 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">23.0 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">46.0 mL</content>
                                 </td>
                              </tr>
                              <tr>
                                 <td>
                                    <content styleCode="bold">1500 lb</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">34.5 mL</content>
                                 </td>
                                 <td>
                                    <content styleCode="bold">69.0 mL</content>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
                     </text>
                     <effectiveTime value="20241115"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="50656fa9-b8c0-488f-a158-c1b0e6408ce2"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, <content styleCode="underline">http://www.fda.gov/reportanimalae</content>.</paragraph>
               </text>
               <effectiveTime value="20241115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="aa27e729-5924-49ce-9d21-c2a93c5942d3"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">OTHER WARNINGS:</content> Do not use in horses intended for human consumption.</paragraph>
                  <paragraph>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
               </text>
               <effectiveTime value="20241115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="2b4c9093-3370-4a62-9482-261871da6923"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Fenbendazole (active ingred.) made in: see imprint.<br/>Formulated in France.<br/>Distributed by:<br/>Intervet Inc. (d/b/a Merck Animal Health) <br/>Rahway, NJ 07065<br/>Approved by FDA under NADA # 104-494<br/>Approved by FDA under NADA # 128-620<br/>©2025 Merck &amp; Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.<br/>Rev. 08/2025</paragraph>
                  <paragraph>API<br/>Made in:</paragraph>
                  <paragraph>LOT <br/>NUMBER:</paragraph>
                  <paragraph>EXPIRATION <br/>DATE:</paragraph>
                  <paragraph>240729 R2</paragraph>
               </text>
               <effectiveTime value="20241115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="f5ef6d07-2539-41d3-bcfc-463f4e3da92e"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label</title>
               <text>
                  <paragraph>panacur<sup>®</sup>
                     <br/> (fenbendazole)</paragraph>
                  <paragraph>Horse &amp; Cattle<br/> Dewormer</paragraph>
                  <paragraph>Suspension 10%<br/> (100 mg/mL)</paragraph>
                  <paragraph>Withdrawal Periods and Residue Warnings: Milk taken<br/>from cows during treatment and for 48 hours after the last<br/>treatment must not be used for human consumption. Cattle<br/>must not be slaughtered for human consumption within<br/>8 days following last treatment with this drug product.<br/>Not for use in beef calves less than 2 months of age, dairy<br/>calves, and veal calves. A withdrawal period has not been<br/>established for this product in pre-ruminating calves.</paragraph>
                  <paragraph>CAUTION: Federal law restricts this drug to use<br/>by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>1,000 mL (33.8 fl oz)</paragraph>
                  <paragraph>MERCK<br/> Animal Health</paragraph>
                  <paragraph>328771 R8</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20241115"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="panacur-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>