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   <code code="50576-8" displayName="OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL" codeSystem="2.16.840.1.113883.6.1"/>
   <title>Strongid® 48</title>
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            <name>Zoetis Inc.</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="54771-0459" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Strongid<suffix>48</suffix>
                        </name>
                        <formCode code="C42938" displayName="GRANULE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>pyrantel tartrate</name>
                           </genericMedicine>
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                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="g" value="105.8"/>
                              <denominator unit="kg" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="SC82VF0480" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PYRANTEL TARTRATE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="4QIH0N49E7" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PYRANTEL</name>
                                 </activeMoiety>
                              </activeMoiety>
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                           <quantity>
                              <numerator unit="kg" value="22.6"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                              <low value="20180824"/>
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               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Strongid® 48</content>
                     <br/>
(pyrantel tartrate)</paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Type A Medicated Article</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Equine Anthelmintic</content>
                     </content>
                  </paragraph>
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               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Drug Ingredient:</title>
               <text>
                  <paragraph>Pyrantel tartrate.........................................10.6% (48 g/lb)</paragraph>
               </text>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Indications for Use:</title>
               <text>
                  <paragraph>For the prevention of <content styleCode="italics">Strongylus vulgaris</content> larval infestation in horses.</paragraph>
                  <paragraph>For control of the following parasites in horses:<br/>Large Strongyles (adults):<content styleCode="italics"> S. vulgaris, S. edentatus</content>
                     <br/>Small Strongyles (adults and fourth-stage larvae): <content styleCode="italics">Cyathostomum </content>spp., <content styleCode="italics">Cylicocyclus </content>spp., <content styleCode="italics">Cylicostephanus </content>spp., <content styleCode="italics">Cylicodontophorus </content>spp., <content styleCode="italics">Poteriostomum </content>spp., <content styleCode="italics">Triodontophorus </content>spp.<br/>Pinworms (adults and fourth-stage larvae):<content styleCode="italics"> Oxyuris equi</content>
                     <br/>Ascarids (adults and fourth-stage larvae): <content styleCode="italics">Parascaris equorum</content>
                  </paragraph>
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               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>CAUTION:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION</content>: For use in manufacturing of equine feeds only.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION</content>: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.<br/>
                     <br/>
Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.</paragraph>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">STORE IN A DRY, COOL PLACE<br/>SEE BACK PANEL FOR FURTHER USE DIRECTIONS</content>
                  </paragraph>
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               <title/>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Net Weight: 50 lb (22.6 kg)</content>
                     </content>
                  </paragraph>
                  <paragraph>Approved by FDA under NADA  # 140-819</paragraph>
                  <paragraph>51047200</paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Mixing and Use Directions</title>
               <text>
                  <paragraph>Strongid is to be administered on a continuous basis either as a top-dress or mixed in the horse’s daily grain ration at the rate of 1.2 mg/lb (2.64 mg/kg) of body weight daily. The duration of administration is for the period during which the horse is at risk of exposure to internal parasites.<br/>
                     <br/>
Foals may be treated at such time when consistent intake of grain mix is occurring. This is generally between 2 and 3 months of age. <br/>
                     <br/>
Strongid may be used in mares at any stage of pregnancy or lactation. Stallion fertility is not affected by the use of Strongid.<br/>
                     <br/>
                     <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>
                     <content styleCode="bold">Typical Mixing Directions to Deliver 1.2 mg/lb (2.64 mg/kg)</content>
                  </paragraph>
                  <table>
                     <col/>
                     <col/>
                     <col/>
                     <col/>
                     <tbody>
                        <tr>
                           <td styleCode=" Botrule">
                              <content styleCode="bold">lb of Medicated Grain Mix per 100 lb of Body Weight</content>
                           </td>
                           <td styleCode=" Botrule">
                              <content styleCode="bold">lb of Strongid 48</content>
                           </td>
                           <td styleCode=" Botrule">
                              <content styleCode="bold">lb of Nonmedicated Feed</content>
                           </td>
                           <td styleCode=" Botrule">
                              <content styleCode="bold">Resulting Concentration (g/ton)</content>
                           </td>
                        </tr>
                        <tr>
                           <td> 2.00</td>
                           <td>2.5</td>
                           <td>1997.5</td>
                           <td>120</td>
                        </tr>
                        <tr>
                           <td>1.5</td>
                           <td>3.3</td>
                           <td>1996.7</td>
                           <td>160</td>
                        </tr>
                        <tr>
                           <td>0.50</td>
                           <td>10.0</td>
                           <td>1990.0</td>
                           <td>480</td>
                        </tr>
                        <tr>
                           <td styleCode=" Botrule">0.20</td>
                           <td styleCode=" Botrule">25.0</td>
                           <td styleCode=" Botrule">1975.0</td>
                           <td styleCode=" Botrule">1200</td>
                        </tr>
                     </tbody>
                  </table>
                  <br/>
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                     <col/>
                     <col/>
                     <col/>
                     <col/>
                     <tbody>
                        <tr>
                           <td styleCode=" Botrule">lb of Medicated Top-Dress per 100 lb of Body Weight</td>
                           <td styleCode=" Botrule">lb of Strongid 48</td>
                           <td styleCode=" Botrule">lb of Nonmedicated Feed</td>
                           <td styleCode=" Botrule">Resulting Concentration (g/ton)</td>
                        </tr>
                        <tr>
                           <td>0.04</td>
                           <td>125.0</td>
                           <td>1875.0</td>
                           <td>6000</td>
                        </tr>
                        <tr>
                           <td>0.025</td>
                           <td>200.0</td>
                           <td>1800.0</td>
                           <td>9600</td>
                        </tr>
                        <tr>
                           <td>0.02</td>
                           <td>250.0</td>
                           <td>1750.0</td>
                           <td>12000</td>
                        </tr>
                        <tr>
                           <td styleCode=" Botrule">0.0125</td>
                           <td styleCode=" Botrule">400.0</td>
                           <td styleCode=" Botrule">1600.0</td>
                           <td styleCode=" Botrule">19200</td>
                        </tr>
                     </tbody>
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               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <title>WARNING</title>
               <text>
                  <paragraph>Do not use in horses intended for human consumption.</paragraph>
               </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>OTHER WARNINGS</title>
               <text>
                  <paragraph>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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               <title>CAUTION</title>
               <text>
                  <paragraph>Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not mix in feeds containing bentonite.</paragraph>
               </text>
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               <title/>
               <text>
                  <paragraph>51047200</paragraph>
                  <paragraph>
Zoetis<br/>
                     <br/>
Distributed by:<br/>
Zoetis Inc.<br/>
Kalamazoo, MI 49007<br/>
Product of Mexico</paragraph>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 50lb bag label</title>
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