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   <title>Praziquantel Tablets<br/> 23 mg<br/> Feline Cestocide<br/>
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                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.</content>
                     <br/> Each Chewable Tablet contains 23 mg praziquantel.</paragraph>
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               <title>DESCRIPTION</title>
               <text>
                  <paragraph>Praziquantel Tablets 23 mg Feline Cestocide are sized for easy oral administration to either adult cats or kittens. The tablets may be crumbled and mixed with the feed.</paragraph>
                  <br/>
                  <br/>
               </text>
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               <title>INDICATIONS</title>
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                  <paragraph>Praziquantel Tablets 23 mg Feline Cestocide are indicated for the removal of the following canine cestodes: <content styleCode="italics">Dipylidium caninum and Taenia,taeniaeformis.</content>
                  </paragraph>
                  <content styleCode="italics">
                     <br/>
                  </content>
                  <br/>
                  <paragraph>
                     <content styleCode="italics">  </content>
                  </paragraph>
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               <title>CONTRAINDICATIONS</title>
               <text>
                  <paragraph>There are no known contraindications to the use of praziquantel in cats.</paragraph>
               </text>
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               <title>ACTION</title>
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                  <paragraph>Praziquantel Tablets are absorbed, metabolized in the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is exhibited.<sup>1</sup>
                     <br/>
                     <br/> Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the mammalian host. Because of this, whole tapeworms, including the scolex, are very rarely passed after administration of praziquantel. In many instances only disintegrated and partially digested pieces of tapeworms will be seen in the stool. The majority of tapeworms killed are digested and are not found in the feces.</paragraph>
                  <br/>
                  <br/>
               </text>
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               <title>USE DIRECTIONS</title>
               <text>
                  <paragraph>Praziquantel Tablets 23 mg Feline Cestocide may be administered directly per os or crumbled and mixed with the feed. The recommended dosage of praziquantel varies according to body weight. Smaller animals require a relatively larger dosage because of their higher metabolic rate. The optimum dose for each individual animal will be achieved by utilizing the following dosage schedule:</paragraph>
                  <br/>
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                     <tbody>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" colspan="2" valign="middle">Cats and Kittens*</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" valign="middle"> 4 pound and under</td>
                           <td styleCode="Rrule" valign="middle"> ½ tablet</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" valign="middle"> 5-11 pounds.</td>
                           <td styleCode="Rrule" valign="middle"> 1 tablet</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" valign="middle">Over 11 pounds</td>
                           <td styleCode="Rrule" valign="middle"> 1½ tablets</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph> *Not intended for use in kittens less than 6 weeks of age.</paragraph>
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               <title>FASTING</title>
               <text>
                  <paragraph>The recommended dosage of praziquantel is not affected by the presence or absence of food in the gastrointestinal tract, therefore, <content styleCode="bold">FASTING IS NEITHER NECESSARY NOR RECOMMENDED.</content>
                  </paragraph>
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               <title>RETREATMENT</title>
               <text>
                  <paragraph>For those animals maintained on premises where reinfections are likely to occur, clients should be instructed in the steps necessary to prevent reinfection; otherwise, retreatment may be necessary. This is especially true in cases of <content styleCode="italics">Dipylidium caninum</content> infections where reinfection is almost certain to occur if ﬂeas are not removed from the animal and its environment.</paragraph>
                  <br/>
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               <title>ANIMAL SAFETY</title>
               <text>
                  <paragraph>The safety index has been derived from controlled safety evaluations, clinical trials and prior approved use in foreign countries. </paragraph>
                  <paragraph>Dosages of 5 times the labeled rate at 14 day intervals to cats as young as 5½ weeks did not produce clinical signs of toxicity. No significant clinical chemistry, hematological, or histopathological changes occurred. Symptoms of gross overdosage include vomition, salivation, diarrhea and depression.</paragraph>
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               <title>PREGNANCY</title>
               <text>
                  <paragraph>Praziquantel tablets have been tested in breeding and pregnant dogs. No adverse effects were noted.</paragraph>
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               <title>ADVERSE REACTIONS</title>
               <text>
                  <paragraph>One instance of diarrhea and one of salivation (1.5%) were reported during the ﬁeld trials in which 135 cats were administered praziquantel tablets 23 feline cestocide.<br/>
                     <br/>
                  </paragraph>
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               <title>CONTACT INFORMATION</title>
               <text>
                  <paragraph>Contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. To report suspected adverse drug experiences, contact Felix Pharmaceuticals Private<br/> Limited at 1-833-571-1525. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae<br/> To obtain a Safety Data Sheet(s), contact Felix Pharmaceuticals Private Limited at 1-833-571-1525.</paragraph>
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               <title>WARNING</title>
               <text>
                  <paragraph>Keep out of the reach of children. Not for human use. </paragraph>
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               <title>STORAGE</title>
               <text>
                  <paragraph>Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].</paragraph>
               </text>
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               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>Bottle of 3, 50 and 150 scored tablets.</paragraph>
                  <paragraph>Each scored tablet contains 23 mg praziquantel.</paragraph>
                  <br/>
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                              <br/>NDC Number </td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>Tablet Size</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>Tablets/Bottle</td>
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                           <td styleCode="Lrule Rrule" align="center" valign="middle">
                              <br/> 86101-020-21</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>23 mg </td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>3 Tablets </td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" align="center" valign="middle">
                              <br/> 86101-020-50</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>23 mg</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>50 Tablets</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" align="center" valign="middle">
                              <br/> 86101-020-13</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>23 mg</td>
                           <td styleCode="Rrule" align="center" valign="middle">
                              <br/>150 Tablets </td>
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                  <br/>
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               <code code="34093-5" codeSystem="2.16.840.1.113883.6.1" displayName="REFERENCES SECTION"/>
               <title>REFERENCES</title>
               <text>
                  <paragraph>
                     <sup>1</sup>Andrews, P. Pharmacokinetic Studies with Droncit<sup>®</sup> in Animals Using a Biological Assay. <content styleCode="italics">Veterinary Medical Review</content> 2/76: 154-165.<br/>
                     <br/>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-834</paragraph>
                  <br/>
                  <paragraph>
                     <content styleCode="bold">Distributed by:</content>
                     <br/> Felixvet Inc.,<br/> 1300 NW Briarcliff Parkway,<br/> Suite 100, Kansas City, Missouri 64150</paragraph>
                  <br/>
                  <paragraph>
                     <content styleCode="bold">Made in India</content>
                  </paragraph>
                  <br/>
                  <paragraph>Neutral Code No. MP/DRUGS/25/90/2020</paragraph>
                  <br/>
                  <paragraph>Rev. November 2025 </paragraph>
               </text>
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               <text>
                  <paragraph>NDC 86101-020-21</paragraph>
                  <paragraph>
                     <content styleCode="bold">Praziquantel Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">23 mg</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Feline Cestocide</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNING: </content>KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.</paragraph>
                  <paragraph>
                     <content styleCode="bold">EACH TABLET CONTAINS: </content>23 mg praziquantel</paragraph>
                  <paragraph>
                     <content styleCode="bold">3 Chewable Tablets</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-834</paragraph>
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                  <paragraph>NDC 86101-020-50</paragraph>
                  <paragraph>
                     <content styleCode="bold">Praziquantel Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">23 mg</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Feline Cestocide</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNING: </content>KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.</paragraph>
                  <paragraph>
                     <content styleCode="bold">EACH TABLET CONTAINS: </content>23 mg praziquantel</paragraph>
                  <paragraph>
                     <content styleCode="bold">50 Chewable Tablets</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-834</paragraph>
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               <title>PACKAGE LABEL.PRINCIPAL DISPLAY PANEL</title>
               <text>
                  <paragraph>NDC 86101-020-13</paragraph>
                  <paragraph>
                     <content styleCode="bold">Praziquantel Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">23 mg</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Feline Cestocide</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">WARNING: </content>KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.</paragraph>
                  <paragraph>
                     <content styleCode="bold">EACH TABLET CONTAINS: </content>23 mg praziquantel</paragraph>
                  <paragraph>
                     <content styleCode="bold">150 Chewable Tablets</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-834</paragraph>
                  <paragraph>
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                  </paragraph>
                  <paragraph>    </paragraph>
                  <br/>
               </text>
               <effectiveTime value="20260122"/>
               <component>
                  <observationMedia ID="MM3">
                     <text>container label-150 count</text>
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