<?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="f98047a7-63fa-40e4-9598-09afcff39d3e"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Sentry HC Worm X DS<br/>For Dogs(pyrantel pamoate)</title>
   <effectiveTime value="20231115"/>
   <setId root="41ddc298-01d3-4060-a656-ac0179930520"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="876995171" root="1.3.6.1.4.1.519.1"/>
            <name>Sergeant's Pet Care Products, LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="003189354" root="1.3.6.1.4.1.519.1"/>
                  <name>Happy Jack</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="048022727" root="1.3.6.1.4.1.519.1"/>
                        <name>ABS Corporation</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="label"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84731" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="pack"/>
                        </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="0f3091e0-7ac8-4fbb-8c2c-34848b326f81"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL listing data elements section"/>
               <effectiveTime value="20231115"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="21091-500" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Sentry HC Worm X DS</name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <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>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="CR6K9C2NHK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYLPARABEN SODIUM</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="60" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="21091-500-02" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C73372" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BUTTERSCOTCH" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20230614"/>
                           </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 root="5cd8d493-18d0-4f8c-bf3f-06679f7f4aeb"/>
               <code code="50744-2" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR OWNERS/CAREGIVERS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Canine Anthelmintic Suspension</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-007</content>
                  </paragraph>
                  <paragraph>
                     <content>WormX DS is a suspension of pyrantel pamoate in a palatable butterscotch flavored vehicle. Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate.</content>
                  </paragraph>
                  <paragraph>Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given below.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lc10127e4-afe2-4bdf-9fb2-41e491bc7df5"/>
                  </paragraph>
                  <paragraph>(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-thienyl) vinyl] pyrimidine 4,4' methylenebis [3-hydroxy-2-naphthoate](1:1)</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20231115"/>
               <component>
                  <observationMedia ID="Lc10127e4-afe2-4bdf-9fb2-41e491bc7df5">
                     <text>Chemical Structure</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="ChemStructure.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="e8e8ac07-a69f-4547-aef7-2771beee3b49"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS FOR USE:</title>
               <text>
                  <paragraph>WormX DS suspension is a highly palatable formulation intended as a single treatment for the removal of large roundworms (<content styleCode="italics">Toxocara canis</content> and <content styleCode="italics">Toxacaris leonina</content>), and hookworms (<content styleCode="italics">Ancylostoma caninum</content> and <content styleCode="italics">Uncinaria stenocephala</content>) in dogs and puppies.</paragraph>
                  <paragraph>WormX DS suspension may also be used to prevent reinfestation of <content styleCode="italics">Toxocara canis</content> in puppies and adult dogs and in lactating bitches after whelping.</paragraph>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.</paragraph>
               </text>
               <effectiveTime value="20231115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="47129b21-a64f-4284-a2af-b11f7efa6eee"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE AND ADMINSITRATION:</title>
               <text>
                  <paragraph>Administer one full teaspoon (5 mL) for each 10 pounds of body weight (2.27 mg base per lb. of body weight). Although most dogs have been observed to find this formulation very palatable and willingly consume it undiluted, it may be necessary to mix a small quantity of formulation in the dog's normal ration to encourage consumption. Fasting prior to and after treatment is not necessary.</paragraph>
                  <paragraph>For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8 and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent <content styleCode="italics">T. canis</content> reinfestation.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO ENSURE UNIFORM RESUSPENSION AND TO ACHIEVE PROPER DOSAGE,<content styleCode="bold"> IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20231115"/>
            </section>
         </component>
         <component>
            <section ID="L7d6d1ff4-4085-4375-a10a-dbfc2db2024c">
               <id root="cbbe56a0-c501-4b2e-8c1f-dd13c4d499a2"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>RECOMMENDED STORAGE: Store below 86°F (30°C).</title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20231115"/>
            </section>
         </component>
         <component>
            <section ID="L76d179fb-8af7-4d33-9ee4-b7e7b4002e68">
               <id root="c1bbea62-c5a7-46e4-ae41-2de3539bc956"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">EFFICACY</content>
                  </paragraph>
                  <paragraph>Critical (worm count) studies in dogs demonstrated that pyrantel pamoate at the recommended dosage is highly efficacious against <content styleCode="italics">T. leonina</content> (99%), <content styleCode="italics">T. canis</content> (85%), <content styleCode="italics">A. caninum</content> (97%), and <content styleCode="italics">U. stenocephala</content> (94%).</paragraph>
                  <paragraph>
                     <content styleCode="bold">SAFETY</content>
                  </paragraph>
                  <paragraph>One of the most outstanding and significant features of pyrantel pamoate is its wide margin of therapeutic safety in dogs. The acute oral LD<sub>50</sub> of pyrantel pamoate administered in gelatin capsules to female and male dogs is greater than 314 mg base per pound of body weight, which indicates a therapeutic index in excess of 138 X the recommended dosage. In subacute and chronic studies, no significant morphological abnormalities could be attributed to pyrantel pamoate when administered to dogs at daily dose rates up to 94 mg base per pound of body weight (40 x) for periods of 19, 30, and 90 days. Clinical studies conducted in a wide variety of geographic locations using more than 40 different breeds of dogs showed no drug-induced toxic effects. Included in these studies were nursing pups, weaned pups, adults, pregnant bitches and males at stud. Additional data have demonstrated the safe use of pyrantel pamoate in (1) dogs having heartworm infections and/or receiving medication for heartworms, (2) dogs exposed to organophosphate flea collars or flea/tick dip treatments, and (3) dogs undergoing concurrent treatment or medication at the time of worming such as immunization and antibacterial treatment.</paragraph>
               </text>
               <effectiveTime value="20231115"/>
            </section>
         </component>
         <component>
            <section ID="Led8ade03-9af7-4601-a2f0-9727dba98766">
               <id root="bb7ae439-52cc-4467-a628-4d10c9c45e6e"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>If you have any questions or comments about this product, please write: SENTRY Consumer Response, PO Box 540399, Omaha, NE 68154-0399.</paragraph>
                  <paragraph>
                     <content>Distributed by:</content>
                  </paragraph>
                  <paragraph>Sergeant's Pet Care Products, Inc., Omaha, NE 68138</paragraph>
               </text>
               <effectiveTime value="20181130"/>
            </section>
         </component>
         <component>
            <section ID="Lbec2ab13-65a9-4fd5-8e27-bb63a038a10c">
               <id root="17bc6635-a6ab-424e-8e84-4147b0e3a661"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 60 mL Bottle</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L66a2d54a-8e69-4823-aa94-e23ab2e09487"/>
                  </paragraph>
               </text>
               <effectiveTime value="20231115"/>
               <component>
                  <observationMedia ID="L66a2d54a-8e69-4823-aa94-e23ab2e09487">
                     <text>60 mL bottle label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="WormXDS Label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="f26e9c87-434d-4b75-80cb-0b23941264e9"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 60 mL Carton</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="MM1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20231115"/>
               <component>
                  <observationMedia classCode="OBS" moodCode="EVN" ID="MM1">
                     <text>image of carton</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="WormXDS Carton.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>