<?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="db06e73f-a265-4e45-996d-f1f6ba244940"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>Vetr Praziquantel, 5% Oral Suspension</title>
   <effectiveTime value="20250417"/>
   <setId root="884ef1fa-afff-4145-a694-2cc39c66454c"/>
   <versionNumber value="3"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="132219984"/>
            <name>Vetr LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="132219984"/>
                        <name>Vetr LLC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" displayName="label" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="4eb7f1f3-31dd-48bd-ad69-fcf0fadf716d"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20250409"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86213-661" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Praziquantel</name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>praziquantel 5% oral</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="50" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </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>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </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>
                        <asContent>
                           <quantity>
                              <numerator value="30" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-661-01" 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="60" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-661-02" 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="120" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-661-03" 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="240" unit="mL"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86213-661-04" 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="20250410"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <code code="C73627" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="unapproved drug other"/>
                           <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="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE"/>
                        </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="L155320d9-62ff-44cd-902b-c0fee675aab5">
               <id root="04544701-3ef6-45fd-bdda-8c15cd3c0b86"/>
               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>Caution</title>
               <text>
                  <paragraph>Shake well before use. Solely for use under the guadance of your veterinarian. Follow dosing instructions from your veterinarian.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="Lbc9c09cd-d765-44bb-b3a7-a0202e980ec9">
               <id root="36a35c2e-6f0d-4515-9b77-2f6d29d38a53"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredients</title>
               <text>
                  <paragraph>Praziquantel USP, 50 mg/mL (5% w/v)</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L304a70a9-70ca-4c2c-be1f-b8bb66a1bd7e">
               <id root="e8e6b8ce-a74d-4ff4-ab24-5602aab11fcf"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Other Ingredients</title>
               <text>
                  <paragraph>Certified vegetable glycerin, natural preservatives and binding agents.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L87e6e221-168a-4c7b-956a-33d1fb9b707c">
               <id root="c3419673-808a-4471-b11d-1c19db465e02"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage</title>
               <text>
                  <paragraph>Store at room temperature at or below 25 C (&lt;77 F)</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L62ddc45a-035f-4c74-8bfb-dd6e76c896fc">
               <id root="6cff5fe9-eb6a-4993-870d-ecf971ade5a3"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph>Solely for use under the guidance of your veterinarian. Please consult your veterinarian for dosing size, duration and readministration schedule.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="Lb59b6065-c050-42fe-8946-f2abe8df8a69">
               <id root="a001e347-ca51-4d50-9979-d718ddafc603"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Say goodbye to tapeworms. Made in the USA. Available in 30mL, 60mL, 120mL and 240mL sizes.</paragraph>
                  <paragraph>Solely for use inder the guidance of your veterinarian.</paragraph>
               </text>
               <effectiveTime value="20250410"/>
            </section>
         </component>
         <component>
            <section ID="L528bff2a-e1d8-49ce-a0b4-2fc9d54dfc57">
               <id root="57818c24-c802-4c2d-a6bd-08a4fad38767"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L19c21752-6899-4c42-a171-af40b5b37292"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250417"/>
               <component>
                  <observationMedia ID="L19c21752-6899-4c42-a171-af40b5b37292">
                     <text>Praziquantel-30mL-Label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Praziquantel-30mL-label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>