<effectiveTime value="20260901"/> <setId root="6a27fabd-4604-4c26-bc7a-9a248883ae56"/> <versionNumber value="1"/> <author> <time/> <assignedEntity> <representedOrganization> <id root="1.3.6.1.4.1.519.1" extension="142988770"/> <name>KEVINWAYNE&GOODS LLC</name> <assignedEntity> <assignedOrganization/> </assignedEntity> </representedOrganization> </assignedEntity> </author> <component> <structuredBody> <component> <section> <id root="1cd4f0c7-fa88-4c2f-8045-b4c07343f523"/> <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/> <title/> <text/> <effectiveTime value="20260901"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="87873-001" codeSystem="2.16.840.1.113883.6.69"/> <name>7 WAY DE-WORMER</name> <formCode code="C42893" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, CHEWABLE"/> <asEntityWithGeneric> <genericMedicine> <name>pyrantel pamoate and praziquantel</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="114" 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> <ingredient classCode="ACTIM"> <quantity> <numerator value="114" 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> <asContent> <quantity> <numerator value="6" unit="1"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="87873-001-01" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43233" displayName="PACKAGE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="12" unit="1"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="87873-001-02" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43233" displayName="PACKAGE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="30" unit="1"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="87873-001-03" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43233" displayName="PACKAGE" 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="20260901"/> </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="C48330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="yellow" xsi:type="CE"> <originalText>YELLOW</originalText> </value> </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="10" xsi:type="PQ"/> </characteristic> </subjectOf> <subjectOf> <characteristic> <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value value="1" xsi:type="INT"/> </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="Lc2fe11f8-df12-4cfd-88c0-2cd116e3ea61"> <id root="0cab52c5-b771-4e39-9189-1381c9bdc7d3"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title>Drug Facts


               
               <text>
                  <paragraph>De-wormer for Medium and Large Dogs Only (Greater than 25 pounds).</paragraph>
               </text>
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            </section>
         </component>
         <component>
            <section ID="L15491ac6-0ca9-463d-9368-ff7abf999637">
               <id root="856626e1-f590-4a32-ab11-a0db9a9b232e"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <title>Uses: For the treatment and control of:
               
                  • Roundworms (Toxocara canis, Toxascaris leonina)
                  • Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala)
                  • Tapeworms (Dipylidium caninum, Taenia pisiformis)


         
            
               
               
               Human Warning:
               
                  Keep this and all medication out of the reach of children. To obtain product information, including a Safety Data Sheet (SDS), call call +1 5165860254.
               
               
            

         
         
            
               
               
               When Using This Product:
               
                  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
                  • Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness.
                  • 7 Way De-Wormer Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.
               
               
            

         
         
            
               
               
               Directions:
               
                  Each flavored chewable contains 114 mg of pyrantel pamoate and 114 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.
                  
                     
                  
                  You should weigh your dog to make sure you are giving the right dose.
7 Way De-Wormer 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 in the back of the dog's mouth for forced swallowing.
Make sure that the dog eats the complete dose.
Watch your dog for a few minutes after dosing to make sure the chewable is not rejected.
                  
               
               
            

         
         
            
               
               
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