<?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="0861d640-5a80-4be1-86a9-eb14c65d366b"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Virbantel<sup>®</sup> Flavored Chewables</title>
   <effectiveTime value="20260218"/>
   <setId root="b79ee411-061a-4c89-8599-72629ba00ac5"/>
   <versionNumber value="13"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="131568396"/>
            <name>Virbac AH, Inc</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="9042621c-353c-4582-a790-81da0f1d2626"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20160909"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="51311-738" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Virbantel</name>
                        <formCode code="C42893" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, CHEWABLE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>pyrantel pamoate/praziquantel</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator value="30" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </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="ACTIB">
                           <quantity>
                              <numerator value="30" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="6490C9U457" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PRAZIQUANTEL</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="6490C9U457" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PRAZIQUANTEL</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="50" unit="1"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" displayName="BOTTLE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="51311-738-10" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43178" displayName="BOX" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20070903"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="NADA141261" 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>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48332" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="brown" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48348" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ROUND" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="9" xsi:type="PQ"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value xsi:type="INT" value="2"/>
                        </characteristic>
                     </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="L8bc975f9-d6ac-49cc-9716-c72cf52f4c95">
               <id root="a9932008-1f79-40f6-a0b8-fa598bfc1369"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Package contents:</title>
               <text>
                  <paragraph>Bottle of 50 flavored chewables</paragraph>
               </text>
               <effectiveTime value="20260302"/>
            </section>
         </component>
         <component>
            <section ID="L71163525-49a2-49cf-bc98-9d843377c293">
               <id root="3dbf85ac-512a-48d0-b478-7f43064f0c5c"/>
               <code code="43678-2" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE FORMS &amp; STRENGTHS SECTION"/>
               <title>Drug Facts</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Active Ingredients (in each chewable)</content>: pyrantel pamoate (30 mg) <content>and praziquantel (30 mg)</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content>
                        <content styleCode="bold">Purpose:</content> De-wormer for Small Dogs and Puppies Only (6.0 to 25 pounds).</content>
                  </paragraph>
               </text>
               <effectiveTime value="20260219"/>
            </section>
         </component>
         <component>
            <section ID="L438cf339-04f6-41e7-9797-dbdc2d3030b4">
               <id root="b8be29be-fd8b-440b-805b-ffcef0a7281d"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses: For the treatment and control of:</title>
               <text>
                  <list listType="unordered">
                     <item>Roundworms (<content styleCode="italics">Toxocara canis, Toxascaris leonina</content>) </item>
                     <item>Hookworms (<content styleCode="italics">Ancylostoma caninum, Ancylostoma braziliense</content>, and <content styleCode="italics">Uncinaria stenocephala</content>)</item>
                     <item>Tapeworms (<content styleCode="italics">Dipylidium caninum, Taenia pisiformis</content>)</item>
                  </list>
               </text>
               <effectiveTime value="20260219"/>
            </section>
         </component>
         <component>
            <section ID="Lcbb890b3-5ef5-4bad-8a6c-531c300270f6">
               <id root="cb2e1025-e539-4d06-887a-be2bc57b6ded"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>Human Warning:</title>
               <text>
                  <paragraph>Keep this and all medication out of the reach of children. To obtain product information, including a Safety Data Sheet (SDS),<br/>call 1-800-338-3659.</paragraph>
               </text>
               <effectiveTime value="20240820"/>
            </section>
         </component>
         <component>
            <section ID="Lb5b8e916-a0cf-4389-87fa-63745920496f">
               <id root="e9c93a24-1d6a-4d8a-b113-dfd6d1247cc4"/>
               <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
               <title>When Using This Product:</title>
               <text>
                  <paragraph>• Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.</paragraph>
                  <paragraph>
                     <content>• Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness.</content>
                  </paragraph>
                  <paragraph>• <content styleCode="bold">VIRBANTEL</content> Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches<br/>has not been tested.</paragraph>
               </text>
               <effectiveTime value="20260219"/>
            </section>
         </component>
         <component>
            <section ID="L9c6a5cf6-344d-442c-84c7-54584214fc65">
               <id root="4833ba87-1ce0-4efd-95bb-b298c8fedb28"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <title>You May Notice:</title>
               <text>
                  <paragraph>Vomiting, loose stools (with or without blood) and decreased activity following treatment. If you notice these signs, contact a veterinarian.</paragraph>
               </text>
               <effectiveTime value="20260219"/>
            </section>
         </component>
         <component>
            <section ID="L50de652b-9ee8-4843-8ce4-700a1d6f5618">
               <id root="1f318581-ae3d-40ba-84c3-6397463a440a"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Directions:</title>
               <text>
                  <paragraph>Each flavored chewable contains 30 mg of pyrantel pamoate and 30 mg of praziquantel. The dose for each drug is 2.27 mg per pound of body weight (5 mg/kg). Please refer to the following dosing table for help finding the right dose for your dog.</paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content>VIRBANTEL<sup>®</sup> Flavored Chewables Dosing Table</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content>
                        <renderMultiMedia referencedObject="L27e22824-cb0a-47d3-b3d5-fcac320a5b7a"/>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content>You should weigh your dog to make sure you are giving the right dose.</content>
                  </paragraph>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">VIRBANTEL</content> Flavored Chewables are palatable if offered by hand. If your dog does not voluntarily eat the chewable, you can hide the chewable in a small amount of food or place it in the back of the dog's mouth for forced swallowing.</item>
                     <item>Make sure that the dog eats the complete dose.</item>
                     <item>Watch your dog for a few minutes after dosing to make sure the chewable is not rejected.</item>
                  </list>
               </text>
               <effectiveTime value="20260302"/>
               <component>
                  <observationMedia ID="L27e22824-cb0a-47d3-b3d5-fcac320a5b7a">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Virbantel Small.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L04bff5fb-ce90-44c0-bc6c-cc351cb4059d">
               <id root="6e2996d9-a9dc-4526-ada2-042388dc1324"/>
               <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
               <title>Other Information</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Recommended De-Worming Schedule:</content>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. De-worming schedules may vary depending on the climate where you live and the activity of your dog.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Re-treatment: </content>
                     <content>Re-treatment of your dog may be necessary as determined by laboratory fecal examination and/or if your dog is living where re-infections are likely to occur. Consult your veterinarian for assistance in the diagnosis and prevention of re-infection. In case of re-infection with tapeworms (</content>
                     <content styleCode="italics">Dipylidium caninum)</content>
                     <content>, consult your veterinarian for advice on how to remove fleas from the dog and the environment.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20240820"/>
            </section>
         </component>
         <component>
            <section ID="Lbea5f6b5-f3bc-4f5f-96ce-d0e0e4b2b824">
               <id root="f846ba82-0951-4633-99de-b105ff5b7ccd"/>
               <code code="69718-5" codeSystem="2.16.840.1.113883.6.1" displayName="STATEMENT OF IDENTITY SECTION"/>
               <title>Manufactured by:</title>
               <text>
                  <paragraph>Virbac AH, Inc.<br/>Fort Worth, TX 76137</paragraph>
               </text>
               <effectiveTime value="20240820"/>
            </section>
         </component>
         <component>
            <section ID="Lae7d7327-231c-4140-aac5-910d4e38a5b0">
               <id root="2b81dc5d-7c0c-4838-9391-31ec135df3f7"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage:</title>
               <text>
                  <paragraph>Store at controlled room temperature of 59-86˚F (15-30˚C).</paragraph>
               </text>
               <effectiveTime value="20240820"/>
            </section>
         </component>
         <component>
            <section ID="L382b4aec-5162-44dd-a8df-07dfc8f6c442">
               <id root="0b0bfcf9-037a-4008-8243-1a9aa108e08e"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions? Comments?</title>
               <text>
                  <paragraph>To report a suspected adverse reaction, call 1-800-338-3659.</paragraph>
                  <paragraph>02/19 301798 - 03</paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA # 141-261</content>
                  </paragraph>
                  <paragraph>©2019 Virbac Corporation.<br/>All Rights Reserved.<br/>VIRBANTEL is a registered<br/>trademark of Virbac S.A.</paragraph>
               </text>
               <effectiveTime value="20240820"/>
            </section>
         </component>
         <component>
            <section ID="Lcac71163-dbe7-4685-940f-fc220f2d4773">
               <id root="99e4413a-bcb1-4031-9954-bf7e9ce9d79b"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2b23e8ee-6b8d-49bf-81ab-c656f7404964"/>
                  </paragraph>
               </text>
               <effectiveTime value="20260302"/>
               <component>
                  <observationMedia ID="L2b23e8ee-6b8d-49bf-81ab-c656f7404964">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Virbantel Small Label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>