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   <title>safe-guard<sup>®</sup>
      <br/> (fenbendazole)<br/> Dewormer</title>
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            <name>Merck Sharp &amp; Dohme Corp.</name>
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                        <code code="57926-088" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Safe-Guard</name>
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                           <genericMedicine>
                              <name>Fenbendazole</name>
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                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="mL"/>
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                              <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FENBENDAZOLE</name>
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                                 <activeMoiety>
                                    <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FENBENDAZOLE</name>
                                 </activeMoiety>
                              </activeMoiety>
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                           <quantity>
                              <numerator value="3785" unit="mL"/>
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                              <numerator value="10000" unit="mL"/>
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               <title>INDICATIONS:</title>
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                        <paragraph>
                           <content styleCode="bold">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 &amp; 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">Goats -</content> 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: <content styleCode="bold">Stomach worms</content> (adults): <content styleCode="italics">Haemonchus contortus</content> and <content styleCode="italics">Teladorsagia circumcincta</content>.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DIRECTIONS:</content> Administer orally. The recommended dose of 2.3 mg/lb (5 mg/kg) of body weight is achieved when 2.3 mL of the drug are given for each 100 lb body weight.</paragraph>
                  <paragraph>
                     <content styleCode="bold">EXAMPLES:</content>
                  </paragraph>
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                     <col width="20%" align="center" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <col width="20%" align="center" valign="top"/>
                     <thead>
                        <tr>
                           <th colspan="2">Cattle:</th>
                           <th/>
                           <th colspan="2">Goats:</th>
                        </tr>
                        <tr>
                           <th>Body Weight</th>
                           <th>Amount</th>
                           <th/>
                           <th>Body Weight</th>
                           <th>Amount</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr>
                           <td>100 lb</td>
                           <td>2.3 mL</td>
                           <td/>
                           <td>25 lb</td>
                           <td>0.6 mL</td>
                        </tr>
                        <tr>
                           <td>200 lb</td>
                           <td>4.6 mL</td>
                           <td/>
                           <td>50 lb</td>
                           <td>1.2 mL</td>
                        </tr>
                        <tr>
                           <td>300 lb</td>
                           <td>6.9 mL</td>
                           <td/>
                           <td>75 lb</td>
                           <td>1.7 mL</td>
                        </tr>
                        <tr>
                           <td>400 lb</td>
                           <td>9.2 mL</td>
                           <td/>
                           <td>100 lb</td>
                           <td>2.3 mL</td>
                        </tr>
                        <tr>
                           <td>500 lb</td>
                           <td>11.5 mL</td>
                           <td/>
                           <td>125 lb</td>
                           <td>2.9 mL</td>
                        </tr>
                        <tr>
                           <td>1000 lb</td>
                           <td>23.0 mL</td>
                           <td/>
                           <td/>
                           <td/>
                        </tr>
                        <tr>
                           <td>1500 lb</td>
                           <td>34.5 mL</td>
                           <td/>
                           <td/>
                           <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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                  <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.</paragraph>
                  <paragraph>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.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Shake well before use.</content>
                  </paragraph>
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                  <paragraph>Fenbendazole (active ingred.) made in: see imprint.<br/>Formulated in France.<br/>Distributed by: Intervet Inc.<br/>(d/b/a Merck Animal Health), Rahway, NJ 07065</paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted drug (California) - Use only as directed.</content>
                  </paragraph>
                  <paragraph>Approved by FDA under NADA # 128-620</paragraph>
                  <paragraph>©2024 Merck &amp; Co., Inc., Rahway, NJ,<br/>USA and its affiliates. All rights reserved.</paragraph>
                  <paragraph>Rev. 04/2024<br/>217157 R1</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label</title>
               <text>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Dewormer</paragraph>
                  <paragraph>for Beef &amp; Dairy Cattle<br/>and Goats</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<br/> veal calves. A withdrawal period has not been<br/>established for this product in pre-ruminating calves.<br/>Goats must not be slaughtered for human consumption<br/>within 6 days following last treatment with this drug<br/>product. Because a milk discard time has not been<br/>established, do not use in lactating goats.</paragraph>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis,<br/>treatment and control of parasitism.</paragraph>
                  <paragraph>1 Gallon (3,785 mL)</paragraph>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>LOT NUMBER:<br/>EXPIRATION DATE:</paragraph>
                  <paragraph>386508 R4</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label</title>
               <text>
                  <paragraph>safe-guard<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Dewormer</paragraph>
                  <paragraph>for Beef &amp; Dairy Cattle<br/> and Goats</paragraph>
                  <paragraph>Suspension 10%<br/> (100 mg/mL)</paragraph>
                  <paragraph>Withdrawal Periods and Residue Warnings: <br/>Milk taken from cows during treatment and for 48 hours<br/>after the last treatment must not be used for human consumption.<br/>Cattle must not be slaughtered for human consumption<br/>within 8 days following last treatment with this drug product.<br/>Not for use in beef calves less than 2 months of age, dairy<br/>calves, and veal calves. A withdrawal period has not been<br/>established for this product in pre-ruminating calves. Goats<br/>must not be slaughtered for human consumption within<br/>6 days following last treatment with this drug product.<br/>Because a milk discard time has not been established,<br/>do not use in lactating goats.</paragraph>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis,<br/>treatment and control of parasitism.</paragraph>
                  <paragraph>1,000 mL (33.8 fl oz)</paragraph>
                  <paragraph>MERCK<br/> Animal Health</paragraph>
                  <paragraph>361394 R9</paragraph>
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                     <text>PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label</text>
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