<?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="53bde34b-b08f-4c82-9c74-508827895dc6"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <effectiveTime value="20250822"/>
   <setId root="16435337-0a10-4d1d-842f-2ea189af4088"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="042125879"/>
            <name>Neogen Corporation-Mercer</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="048022727"/>
                        <name>ABS Corporation</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="428655732"/>
                        <name>COSMA Spa</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" displayName="api manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="67073f4b-a720-4288-b37f-bc9b814694da"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20250821"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="59051-6009" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Pyrid 2X<suffix>Canine Anthelmintic</suffix>
                        </name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>pyrantel pamoate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator value="4.54" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="81BK194Z5M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PYRANTEL PAMOATE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="4QIH0N49E7" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PYRANTEL</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="473.2" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="59051-6009-6" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" displayName="BOTTLE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="946.4" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="59051-6009-7" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" displayName="BOTTLE, PLASTIC" 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="20250818"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="ANADA200007" 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="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="L3c82da89-cafc-491a-b3ef-9e70f37974a0">
               <id root="698ea636-dfa4-4637-81c0-d5445b7fb9a4"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Pyrid 2x<br/>
                  <content styleCode="italics">(pyrantel pamoate oral suspension)</content>
                  <br/>Canine Anthelmintic Suspension<br/>
                  <br/>DESCRIPTION &amp; INDICATIONS AND USAGE SECTIONS</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Pyrid 2x</content>
                     <br/>
                     <content styleCode="italics">(pyrantel pamoate oral suspension)</content>
                     <br/>
                     <content styleCode="bold">Canine Anthelmintic Suspension</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DESCRIPTION:</content> Pyrid 2x liquid wormer is a suspension of pyrantel pamoate in a palatable<br/>butterscotch flavored vehicle. Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate.<br/>
                     <br/>Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines.<br/>It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic<br/>acid containing 34.7% base activity. The chemical structure and name are given below:</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Le6bcb610-0ede-4d24-98e2-5263b2025899"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS AND USAGE:</content> Pyrid 2x suspension is a highly palatable formulation intended as a<br/>single treatment for the removal of large roundworms <content styleCode="italics">(Toxocara canis and Toxascaris leonina)</content> and<br/>hookworms <content styleCode="italics">(Ancylostoma caninum and Uncinaria stenocephala)</content> in dogs and puppies. The presence<br/>of these parasites should be confirmed by laboratory fecal exam. Consult your veterinarian for<br/>assistance in the diagnosis, treatment, and control of parasitism.</paragraph>
                  <paragraph>Pyrid 2x suspension may also be used to prevent reinfestation of <content styleCode="italics">T.canis</content> in puppies and adult dogs<br/>and in lactating bitches after whelping.</paragraph>
               </text>
               <effectiveTime value="20250822"/>
               <component>
                  <observationMedia ID="Le6bcb610-0ede-4d24-98e2-5263b2025899">
                     <text>Chemical Structure</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Chemical Structure.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L161bf039-f159-4464-b76c-8c667924831e">
               <id root="9e73d4de-1c56-45b2-92c9-74ff093cd32d"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS SECTION</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO ENSURE<br/>UNIFORM RESUSPENSION AND TO ACHIEVE PROPER DOSAGE, <content styleCode="bold">IT IS EXTREMELY IMPORTANT THAT</content>
                     <br/>
                     <content styleCode="bold">THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.</content>
                     <br/>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                  </paragraph>
               </text>
               <effectiveTime value="20250822"/>
            </section>
         </component>
         <component>
            <section ID="L336d8b29-4b75-489a-8665-4cf5cff822fe">
               <id root="be5e0c24-ed52-4566-b5fc-b2d9161aeba1"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE AND ADMINISTRATION Section</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE AND ADMINISTRATION:</content> Administer 1 teaspoon (5 mL) for each 10 lb of body weight. It is<br/>not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very<br/>palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the dose, mix<br/>in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained<br/>under conditions of constant exposure to worm infestation should have a follow-up fecal exam<br/>within 2-4 weeks after treatment.</paragraph>
                  <paragraph>For maximum control and prevention of reinfestation, it is recommended that puppies be treated at<br/>2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult<br/>dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent <content styleCode="italics">T. canis</content>
                     <br/>reinfestation.</paragraph>
               </text>
               <effectiveTime value="20250822"/>
            </section>
         </component>
         <component>
            <section ID="L902c95af-e2de-41d1-9485-d3678fc77d3d">
               <id root="0309a6a7-63be-407b-bbe5-6b2c2e8b3037"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <title>SAFETY AND EFFICACY STUDIES SECTION</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">SAFETY AND EFFICACY STUDIES:</content> Critical (worm count) studies in dogs demonstrated that<br/>pyrantel pamoate at the recommended dosage is highly efficacious against <content styleCode="italics">T. leonina</content> (99%),<br/>
                     <content styleCode="italics">T. canis</content> (85%), <content styleCode="italics">A. caninum</content> (97%), and <content styleCode="italics">U. stenocephala</content> (94%).</paragraph>
                  <paragraph>One of the most outstanding and significant features of pyrantel pamoate is its wide margin<br/>of therapeutic safety in dogs. The acute oral LD(50) of pyrantel pamoate administered in<br/>gelatin capsules to female and male dogs is greater than 314 mg base per lb of body weight,<br/>which indicates a therapeutic index in excess of 138 times the recommended dosage. In<br/>subacute and chronic studies, no significant morphological abnormalities could be attributed<br/>to pyrantel pamoate when administered to dogs at daily dose rates up to 94 mg base per<br/>pound of body weight (40x) for periods of 19, 30, and 90 days. Clinical studies conducted in a<br/>wide variety of geographic locations using more than 40 different breeds of dogs showed no<br/>drug-induced toxic effects. Included in these studies were nursing pups, weaned pups,<br/>adults, pregnant bitches, and males at stud.</paragraph>
                  <paragraph>Additional data has demonstrated the safe use of pyrantel pamoate in dogs having heartworm<br/>infestations and/or receiving medication for heartworms, dogs exposed to organophosphate<br/>flea collars or flea/tick-dip treatments, and dogs undergoing concurrent treatment or medication<br/>at the time of worming such as immunization and antibacterial treatment.</paragraph>
               </text>
               <effectiveTime value="20250821"/>
            </section>
         </component>
         <component>
            <section ID="L98f8f504-1415-436b-b42b-02d38d7a7737">
               <id root="9511150c-5442-4724-8154-732cb46cf540"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORAGE AND HANDLING SECTION</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">RECOMMENDED STORAGE:</content> STORE BELOW 86° F (30° C). Keep Pyrid 2x in a secure location out<br/>of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.<br/>HOW SUPPLIED<content styleCode="bold">:</content> Pyrid 2x is supplied in 2 fl. oz. (60 mL), 16 fl. oz. (474 mL), and 32 fl. oz. (946 mL)<br/>bottles.</paragraph>
               </text>
               <effectiveTime value="20250822"/>
            </section>
         </component>
         <component>
            <section ID="L02781bf7-2cf8-4fed-9fd0-48913e3bbcb3">
               <id root="4f698030-164b-4cc7-af70-119e14e9d990"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>CONTACT INFORMATION SECTION</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-007</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Contact Information: </content>To report suspected adverse events or for medical assistance<br/>
                     <content>contact 1-800-498-5743. For technical assistance or to obtain a copy of the Safety Data Sheet</content>
                     <content>(SDS), contact Neogen Corporation at 1-859-254-1221. For additional information about</content>
                     <content>adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or</content>
                     <content>http://www.fda.gov/reportanimalae</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <content>Neogen Corporation</content>
                     <content>620 Lesher Place</content>
                     <content>Lansing, MI 48912 USA</content>
                     <content>provectapet.com</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For customer questions call 1-859-254-1221</content>
                     <br/>
                     <content styleCode="bold">For medical emergencies call 1-800-498-5743</content>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L54a9f60f-2145-4906-8baa-a493d4c5615d"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250822"/>
               <component>
                  <observationMedia ID="L54a9f60f-2145-4906-8baa-a493d4c5615d">
                     <text>Take Time Observe Label Directions</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Take Time Observe Label Directions.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="La3bc05a1-ca4e-4a10-a6f0-9c41982c5682">
               <id root="08493e34-d2fe-481d-ab82-dbab8886ea14"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Pyrid™ 2x</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(pyrantel pamoate oral suspension)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Canine Anthelmintic Suspension</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">IMPORTANT: SHAKE WELL BEFORE USING</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Active Ingredient:</content> 4.54 mg of Pyrantel Base as Pyrantel Pamoate per mL</paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA #200-007</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS – 16 fl. oz. (474 mL) </content>
                  </paragraph>
                  <paragraph>PROVECTA®</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lb7fd1333-d974-486a-9ca0-75a08a41e4c1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250822"/>
               <component>
                  <observationMedia ID="Lb7fd1333-d974-486a-9ca0-75a08a41e4c1">
                     <text>Pyrid 2x _ 16 fl oz - Neogen Corporation</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pyrid 2x _ 16 fl oz - Neogen Corporation.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L61116fb0-0a38-4a5b-8f8f-a90ce6854770">
               <id root="f620c21e-1f6c-4433-a419-21e613a16443"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Pyrid™ 2x</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(pyrantel pamoate oral suspension)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Canine Anthelmintic Suspension</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">IMPORTANT: SHAKE WELL BEFORE USING</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Active Ingredient:</content> 4.54 mg of Pyrantel Base as Pyrantel Pamoate per mL</paragraph>
                  <paragraph>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA #200-007</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS – 32 fl. oz. (946 mL)</content>
                  </paragraph>
                  <paragraph>PROVECTA®</paragraph>
                  <paragraph/>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lc6bc78d9-0504-40ce-9220-895034745913"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250822"/>
               <component>
                  <observationMedia ID="Lc6bc78d9-0504-40ce-9220-895034745913">
                     <text>Pyrid 2x _ 32 fl oz - Neogen Corporation</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pyrid 2x _ 32 fl oz - Neogen Corporation.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>