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   <title>Sulforal (sulfadimethoxine)</title>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Concentrated Solution 12.5%</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Antibacterial for use in drinking water.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">3.75g sulfadimethoxine/fl.oz. / 1 Gallon (3.8L)</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA #200-251</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Protect From Light - </content>
                     <content styleCode="bold">For oral use in chickens, turkeys, and cattle.</content>
                  </paragraph>
                  <paragraph/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Broiler and Replacement Chickens - </content>Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Meat-producing Turkeys -</content>
                     <content> Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Dairy Calves, Dairy Heifers, and Beef Cattle - </content>
                     <content>Use for the treatment of shipping fever complex and bacterial pneumonia associated with </content>
                     <content styleCode="italics">Pasteurella </content>
                     <content>spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with </content>
                     <content styleCode="italics">Fusobacterium necrophorum</content>
                     <content> (</content>
                     <content styleCode="italics">Sphaerophorus necrophorus</content>
                     <content>) sensitive to sulfadimethoxine.</content>
                  </paragraph>
                  <paragraph/>
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               <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Store at room temperature; if freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily.</paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Chickens and Turkeys</content>
                     <content styleCode="bold">
                        <content styleCode="bold">-</content>
                     </content>If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.0.25%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication.</paragraph>
                  <paragraph>Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.</paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle</content>
                     <content styleCode="bold">-</content> During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days.</paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted Drug (California) - Use Only as Directed. Not for Human Use.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">CONTACT INFORMATION:</content>
                     <content>To report suspected adverse drug events, for technical </content>
                     <content>assistance or to obtain a copy of the Safety Data Sheet (SDS), </content>
                     <content>contact Dechra at (866) 933-2472.</content>
                  </paragraph>
                  <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Chickens and Turkeys</content>-Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.<br/>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Cattle</content>
                     <content styleCode="bold">
                        <content styleCode="bold">
                           <content styleCode="bold">-</content>
                        </content>
                     </content>Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only.</paragraph>
                  <paragraph>A withdrawal period has not been established for this product in preruminating calves.</paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Do Not Use in Calves to be Processed For Veal</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT</content>
                  </paragraph>
                  <paragraph/>
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                        <name>Sulforal</name>
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                              <name>sulfadimethoxine oral solution</name>
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                              <name>Sulfadimethoxine</name>
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                                    <name>Sulfadimethoxine</name>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Dosage and Administration:</content>
                  </paragraph>
                  <table width="527px" border="1" cellspacing="0" cellpadding="0">
                     <tbody>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Chickens and Turkeys</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold"> Treatment Period:</content> 6 consecutive days<br/>
                                 <content styleCode="bold"> Recommended Concentration:</content> Chickens<content styleCode="bold"> -</content>0.05%; Turkeys -0.025%<br/>
                                 <content styleCode="bold"> Chickens  </content>Add 1 fl oz (30 mL)  to 2  gal of drinking water or <br/>                      25 fl oz to 50 gal of drinking water.<br/>
                                 <content styleCode="bold"> Turkeys   </content>Add 1 fl oz (30 mL) 4 gal of drinking water or <br/>                     25 fl oz to 100 gal of drinking water.<br/>
                                 <content styleCode="bold"> Automatic Proportioners* Stock Solution - </content>To make 2 gal of stock solution:<br/>
                                 <content styleCode="bold"> Chickens </content>Add 1 gal of Sulforal Concentrated Solution 12.5% to 1gal of water.<br/>
                                 <content styleCode="bold"> Turkeys   </content>Add 2 qt of Sulforal Concentrated Solution 12.5% to 6 qt of water.<br/>  *Set proportioner to a feed rate of 1 fl oz of stock solution per gal of water</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td/>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Dairy Calvers, Dairy Heifers and Beef Cattle</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold"> Treatment Period:</content> 5 consecutive days<br/>
                                 <content styleCode="bold"> Dosage:</content> Initial dose of 25 mg/lb followed by four maintenance dose<br/>                of 12.5 mg/lb/day.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td/>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Summer Administration</content>
                                 <br/> Dosage recommendations for summer are based on an estimated water intake of 1 gal of water for every 100 lb of body weight per day.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">         Sulfadimethoxine Concentrated Solution 12.5%</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Daily Drinking Water Supply         Initial Dose         Maintenance Dose</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>      25 gal                                       1 pt (16 fl oz)                 1 cup (8 fl oz)<br/>       50 gal                                       1 qt (32 fl oz)                 1 pt (16 fl oz)<br/>     200 gal                                       1 gal (128 fl oz)              2 qt (64 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td/>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Winter Administration</content>
                                 <br/> Dosage recommendations for summer are based on an estimated water intake of 1 gal of water for every 150 lb of body weight per day.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Sulfadimethoxine Concentrated Solution 12.5%</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Daily Drinking Water Supply         Initial Dose         Maintenance Dose</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>      16 gal                                       1 pt (16 fl oz)                 1 cup (8 fl oz)<br/>       33 gal                                       1 qt (32 fl oz)                 1 pt (16 fl oz)<br/>     127 gal                                       1 gal (128 fl oz)              2 qt (64 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">For individual treatment of cattle,</content> Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicated one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.<br/>
                                 <br/>
                              </paragraph>
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                  <paragraph>
                     <content styleCode="bold">STORAGE:  </content> Store at Controlled Room Temperature 15°-30°C (59°-86°F).</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>Dechra Veterinary Products, LLC<br/>Overland Park, KS 66211</paragraph>
                  <paragraph/>
                  <paragraph>Rev. 05/2023</paragraph>
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