<effectiveTime value="20221221"/> <setId root="686a4260-c835-4e0a-b329-0bdef15da515"/> <versionNumber value="1"/> <author> <time/> <assignedEntity> <representedOrganization> <id extension="056387798" root="1.3.6.1.4.1.519.1"/> <name>Durvet, Inc.</name> </representedOrganization> </assignedEntity> </author> <component> <structuredBody> <component> <section> <id root="dc1c7d46-9f74-4b99-828f-658e2ca69387"/> <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/> <effectiveTime value="20221221"/> <subject> <manufacturedProduct> <manufacturedProduct> <code codeSystem="2.16.840.1.113883.6.69" code="30798-200"/> <name>Durvet Feline Tape Tabs<suffix>for Cats</suffix> </name> <formCode code="C42893" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, CHEWABLE"/> <asEntityWithGeneric> <genericMedicine> <name>praziquantel tablets</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator unit="mg" value="23"/> <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 unit="1" value="3"/> <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 unit="1" value="1"/> <denominator value="1"/> </quantity> <containerPackagedProduct> <code code="30798-200-62" 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> <approval> <id extension="NADA111798" 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> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20140516"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <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> <subjectOf> <characteristic classCode="OBS"> <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value unit="mm" value="10" xsi:type="PQ"/> </characteristic> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <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 classCode="OBS"> <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value value="2" 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="s1"> <id root="5a5f3e80-3bdb-4f3c-bd50-e59d73c62a19"/> <code codeSystem="2.16.840.1.113883.6.1" code="42229-5" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">durvet</content> </paragraph> <paragraph> <content styleCode="bold">Feline</content> </paragraph> <paragraph> <content styleCode="bold">Tape Tabs</content> <sub>™</sub> </paragraph> <paragraph>(praziquantel tablets) <content styleCode="bold">FOR CATS</content> </paragraph> <paragraph> <content styleCode="bold">Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.</content> </paragraph> <paragraph> <content styleCode="bold">Consult your veterinarian before administering the tablets to weak or debilitated animals.</content> </paragraph> <paragraph>Each tablet contains 23 mg praziquantel.</paragraph> </text> <effectiveTime value="20221221"/> </section> </component> <component> <section ID="s2"> <id root="451b381a-efe4-4fad-9790-9d01f74dd126"/> <code codeSystem="2.16.840.1.113883.6.1" code="34089-3" displayName="DESCRIPTION SECTION"/> <title>DESCRIPTION: Feline Tape Tabs (praziquantel tablets) are sized for easy oral administration to either adult cats or kittens. The tablets may be crumbled and mixed with the feed.
USES: Feline Tape Tabs (praziquantel tablets) will remove the common tapeworms, Dipylidium caninum and Taenia taeniaeformis, from cats and kittens.
DOSAGE AND ADMINISTRATION: Feline Tape Tabs (praziquantel tablets) may be given directly in the mouth or crumbled and mixed with the food. Administer to cats and kittens* only as follows:
*Not intended for use in kittens less than 6 weeks of age.
Body Weight (lbs) No. of Tablets
4 pounds and under ½ tablet
5-11 pounds 1 tablet
Over 11 pounds 1 ½ tablets
FASTING IS NEITHER NECESSARY NOR RECOMMENDED.
RETREATMENT: Steps should be taken to control fleas and rodents on the premises in order to prevent reinfection; otherwise, retreatment will be necessary. This is especially true in cases of tapeworms transmitted by fleas (Dipylidium caninum) where reinfection is almost certain to occur if fleas are not removed from the animal and its environment. If reinfection occurs, tapeworm segments may be observed within one month of the initial treatment.
SIDE EFFECTS: Isolated incident of either salivation or diarrhea have been reported following treatment, but were considered non-significant. If these signs are observed and they persist, consult your veterinarian. Questions? For product questions, to report side effects, or for a copy of the Safety Data Sheet (SDS), call Durvet, Inc. at 1-800-821-5570. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
WARNING: Keep out of the reach of children.
Not for human use.
HOW SUPPLIED: Bottle of 3 scored tablets. Each scored tablet contains 23 mg praziquantel.
STORAGE CONDITIONS: Store at less than or equal to 25°C (77°F). durvet Mfd. for: Durvet, Inc.
100 S.E. Magellan Drive
Blue Springs, MO 64014
www.durvet.com ISS22XB07 Approved by FDA under NADA # 111-798 Made in China 90211089_PA600301X
Principal Display Panel Feline Tape Tabs™ (praziquantel tablets) FOR CATS CONTAINS
3 TABLETS EACH TABLET CONTAINS:
23 mg praziquantel WARNING: KEEP OUT OF REACH OF
CHILDREN. NOT FOR HUMAN USE. Feline Tape Tabs™ (praziquantel tablets) FOR CATS Tapeworm Tablet
for Cats 3
TABLETS EACH TABLET
CONTAINS:
23 mg praziquantel durvet WARNING: KEEP OUT OF REACH OF
CHILDREN. NOT FOR HUMAN USE. Principal Display Panel - Bottle, Plastic Label Principal Display Panel - Carton Label