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   <title>panacur<sup>®</sup>
      <br/> (fenbendazole) <br/> Dewormer</title>
   <effectiveTime value="20241115"/>
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            <name>Merck Sharp &amp; Dohme Corp.</name>
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                  <name>Intervet Production S.A.</name>
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                        <name>Panacur</name>
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                              <name>Fenbendazole</name>
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                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FENBENDAZOLE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FENBENDAZOLE</name>
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                              <low value="20090916"/>
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                  <paragraph>
                     <content styleCode="bold">INDICATIONS: Beef and Dairy Cattle</content> - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: <content styleCode="bold">Lungworms:</content> Adult <content styleCode="italics">Dictyocaulus viviparus</content>; <content styleCode="bold">Stomach worms:</content> Adult brown stomach worms (<content styleCode="italics">Ostertagia ostertagi</content>), Adult and fourth stage larvae barberpole worms (<content styleCode="italics">Haemonchus contortus</content> &amp; <content styleCode="italics">H. placei</content>), and Adult and fourth stage larvae small stomach worms (<content styleCode="italics">Trichostrongylus axei</content>); <content styleCode="bold">Intestinal worms</content> (Adult and fourth stage larvae): hookworms (<content styleCode="italics">Bunostomum phlebotomum</content>), thread-necked intestinal worms (<content styleCode="italics">Nematodirus helvetianus</content>), small intestinal worms (<content styleCode="italics">Cooperia punctata</content> &amp; <content styleCode="italics">C. oncophora</content>), bankrupt worms (<content styleCode="italics">Trichostrongylus colubriformis</content>), and nodular worms (<content styleCode="italics">Oesophagostomum radiatum</content>).</paragraph>
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                        <paragraph>
                           <content styleCode="bold">Beef Cattle Only</content> – 4.6 mg/lb (10 mg/kg) body weight for the treatment and control of: <content styleCode="bold">Stomach worms</content> (4th stage inhibited larvae): <content styleCode="italics">Ostertagia ostertagi</content> (Type II Ostertagiasis);  <content styleCode="bold">Tapeworms:</content>
                           <content styleCode="italics"> Moniezia benedeni.</content>
                        </paragraph>
                        <paragraph>
                           <content styleCode="bold">Do not use in dairy cattle at 10 mg/kg.</content>
                        </paragraph>
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                     <effectiveTime value="20241107"/>
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                  <paragraph>
                     <content styleCode="bold">DIRECTIONS:</content> Administer orally. In beef and dairy cattle, the recommended dose of 2.3 mg/lb (5 mg/ kg) is achieved when 2.3 mL of the drug are given for each 100 lb of body weight. In beef cattle only, the recommended dose of 4.6 mg/lb (10 mg/kg) for treatment and control of Type II Ostertagiasis (4th stage inhibited larvae) or tapeworms is achieved when 4.6 mL of the drug is given for each 100 lb of body weight.</paragraph>
                  <paragraph>
                     <content styleCode="bold">EXAMPLES:</content>
                  </paragraph>
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                     <thead>
                        <tr>
                           <th>Cattle Weight</th>
                           <th>Dose<br/>(2.3 mg/lb)</th>
                           <th>Dose<br/>4.6 mg/lb</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold">100 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">2.3 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">4.6 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">200 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">4.6 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">9.2 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">300 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">6.9 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">13.8 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">400 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">9.2 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">18.4 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">500 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">11.5 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">23.0 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">1000 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">23.0 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">46.0 mL</content>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">1500 lb</content>
                           </td>
                           <td>
                              <content styleCode="bold">34.5 mL</content>
                           </td>
                           <td>
                              <content styleCode="bold">69.0 mL</content>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>Do not underdose. 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>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content> NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or <content styleCode="underline">http://www.fda.gov/reportanimalae.</content>
                  </paragraph>
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               <text>
                  <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>
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                  <paragraph>
                     <content styleCode="bold">Store at or below 25°C (77°F). Protect from freezing. Shake well before use.</content>
                  </paragraph>
               </text>
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               <text>
                  <paragraph>Fenbendazole (active ingred.) made in: see imprint. Formulated in France.</paragraph>
                  <paragraph>Distributed by: Intervet Inc (d/b/a Merck Animal Health), Rahway, NJ 07065</paragraph>
                  <paragraph>Approved by FDA under NADA # 128-620<br/>©2024 Intervet Inc., a subsidiary of Merck &amp; Co. Inc.<br/>Rev. 04/2024</paragraph>
                  <paragraph>217030 R1</paragraph>
               </text>
               <effectiveTime value="20241112"/>
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               <title>PRINCIPAL DISPLAY PANEL - 1 Gallon (3785 mL) Bottle Label</title>
               <text>
                  <paragraph>panacur<sup>®</sup>
                     <br/> (fenbendazole)</paragraph>
                  <paragraph>Dewormer<br/> for Beef &amp; Dairy Cattle</paragraph>
                  <paragraph>Suspension 10%<br/>(100 mg/mL)</paragraph>
                  <paragraph>Withdrawal Periods and Residue Warnings: Milk<br/>taken from cows during treatment and for 48 hours<br/>after the last treatment must not be used for human<br/>consumption. Cattle must not be slaughtered for<br/>human consumption within 8 days following last<br/>treatment with this drug product. Not for use in beef<br/>calves less than 2 months of age, dairy calves, and veal<br/>calves. A withdrawal period has not been established<br/>for this product in pre-ruminating calves.</paragraph>
                  <paragraph>CAUTION: Federal law restricts this drug to use<br/>by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>1 Gallon (3,785 mL)</paragraph>
                  <paragraph>API MADE IN:</paragraph>
                  <paragraph>LOT NUMBER:</paragraph>
                  <paragraph>EXPIRATION DATE:</paragraph>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>165509 R1</paragraph>
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                     <text>PRINCIPAL DISPLAY PANEL - 1 Gallon (3785 mL) Bottle Label</text>
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