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            <name>Bimeda Inc.</name>
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                        <name>Exodus</name>
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                              <name>Pyrantel Pamoate</name>
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                              <name>PYRANTEL PAMOATE</name>
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                  <paragraph>
                     <content styleCode="bold">Read Entire Carton Carefully Before Using This Product</content>
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                  <paragraph>
                     <content styleCode="bold">DESCRIPTION:</content>
                  </paragraph>
                  <paragraph>Exodus® (pyrantel pamoate) Paste is a pale yellow to buff paste containing 43.9% w/w pyrantel pamoate in an inert vehicle. Each syringe contains 3.6 grams pyrantel base in 23.6 grams paste. Each mL contains 171 mg pyrantel base as pyrantel pamoate.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">COMPOSITION:</content>
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                  <paragraph>Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given above.</paragraph>
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                     <content styleCode="bold">CHEMICAL STRUCTURE:</content>
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                     <content>Chemical name: (E)-1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)-vinyl]-pyrimidine 4,4' methylenebis [3-hydroxy-2-naptholate] (1:1)</content>
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                     <content styleCode="bold">INDICATIONS FOR USE:</content>
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                  <paragraph>For the removal and control of mature infections of large strongyles (<content styleCode="italics">Strongylus vulgaris, S. edentatus, S. equinus</content>); small strongyles; pinworms (<content styleCode="italics">Oxyuris equi</content>); and large roundworms <content styleCode="italics">(Parascaris equorum</content>) in horses and ponies.</paragraph>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DOSAGE AND TREATMENT</content>:</paragraph>
                  <paragraph>Exodus® (pyrantel pamoate) Paste is to be administered as a single oral dose of 3 mg pyrantel base per lb of body weight. The syringe has 4 weight mark increments. Each weight mark indicates the recommended dose for 300 lb of body weight.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">            DOSAGE</content>
                  </paragraph>
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                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Body Weight Range</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Volume</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">mg Pyrantel Base</content>
                              </paragraph>
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                              <paragraph>up to 300 lb</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>¼ syringe</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>900 mg</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>301 – 600 lb</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>½ syringe</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>1800 mg</paragraph>
                           </td>
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                        <tr>
                           <td valign="top">
                              <paragraph>601 - 900 lb</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>¾ syringe</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>2700 mg</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>901 - 1200 lb</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>1 full syringe</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>3600 mg</paragraph>
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                     <content styleCode="bold">Note:</content> Position ring-gauge over appropriate mark on plunger. Each mL contains 171 mg of pyrantel base as pyrantel pamoate.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Do not underdose.</content> Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
                  <paragraph/>
                  <paragraph>For maximum control of parasitism, it is recommended that foals (2-8 months of age) be dosed every 4 weeks. To minimize the potential source of infection that the mare may pose to the foal, the mare should be treated 1 month prior to anticipated foaling date by retreatment 10 days to 2 weeks after birth of foal. Horses and ponies over 8 months of age should be routinely dosed every 6 weeks.</paragraph>
                  <paragraph>It is recommended that severely debilitated animals not be treated with this preparation.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">ADMINISTRATION:</content>
                  </paragraph>
                  <paragraph>After removing the cap, the paste should be deposited on the dorsum of the tongue. Introduce the nozzle end of the syringe at the corner of the mouth. Direct the syringe backwards and depress the plunger to deposit the paste onto the tongue. Given in this manner, it is unlikely that rejection of the paste will occur. Raising the horse’s head sometimes assists in the swallowing process. When only part of the paste has been used, replace the cap on the syringe nozzle.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">EFFICACY:</content>
                  </paragraph>
                  <paragraph>Critical (worm count) studies in horses demonstrated that pyrantel pamoate administered at the recommended dosage was efficacious against mature infections of <content styleCode="italics">Strongylus vulgaris</content> (&gt;90%), <content styleCode="italics">S. edentatus</content> (69%), <content styleCode="italics">S. equinus</content> (&gt;90%), <content styleCode="italics">Oxyuris equi</content> (81%), <content styleCode="italics">Parascaris equorum</content> (&gt;90%), and small strongyles (&gt;90%).</paragraph>
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                  <paragraph>
                     <content styleCode="bold">WARNINGS </content>
                  </paragraph>
                  <paragraph>For oral animal use only. Do not use in horses intended for human consumption.</paragraph>
                  <paragraph>
                     <content styleCode="bold">HUMAN WARNINGS: </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Keep out of the reach of children.</content>
                  </paragraph>
                  <paragraph>It is recommended that severely debilitated animals not be treated with this preparation.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">OTHER WARNINGS: </content>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
                  <paragraph/>
                  <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at <linkHtml href="http://www.fda.gov/reportanimalae">www.fda.gov/reportanimalae</linkHtml>.</paragraph>
                  <paragraph/>
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                  <paragraph>
                     <content styleCode="bold">RECOMMENDED STORAGE</content>: Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F).</paragraph>
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                  <paragraph>Approved by FDA under ANADA # 200-350</paragraph>
                  <paragraph>Exodus®</paragraph>
                  <paragraph>(pyrantel pamoate) Paste</paragraph>
                  <paragraph>Horse Dewormer</paragraph>
                  <paragraph>
                     <content>Net Wt. 23.6 g</content>
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