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   <title>SULFASOL SOLUBLE POWDER</title>
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                        <name>SULFASOL </name>
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                              <name>SULFADIMETHOXINE SODIUM</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="94.6" unit="g"/>
                              <denominator value="107" unit="g"/>
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                              <code code="49DG2B481W" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SULFADIMETHOXINE SODIUM</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="30CPC5LDEX" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SULFADIMETHOXINE</name>
                                 </activeMoiety>
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               <text>
                  <paragraph>(Brand of Sulfadimethoxine)</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Antibacterial</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">CAUTION:  </content>Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph/>
                  <paragraph>Approved by FDA under ANADA #200-238</paragraph>
                  <paragraph/>
                  <paragraph>Restricted Drug (California) - Use Only as Directed. Not for Human Use.</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Net Wt.: 3.77 oz (107g)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Each packet contains 3.34 oz. (94.6 g) sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.</content>
                  </paragraph>
                  <paragraph/>
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                  <paragraph>
                     <content styleCode="bold">INDICATIONS FOR USE:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Broiler and Replacement Chickens Only - </content>
                     <content>Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Meat-producing Turkeys Only - </content>Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For Dairy Calves, Dairy Heifers, and Beef Cattle - </content>Use for the treatment of shipping fever complex and bacterial pneumonia associated with <content styleCode="italics">Pasteurella</content> spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with <content styleCode="italics">Sphaerophorus necrophorus</content> sensitive to sulfadimethoxine.</paragraph>
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               <text>
                  <table border="1" cellspacing="0" cellpadding="0">
                     <tbody>
                        <tr>
                           <td colspan="4" valign="top"/>
                           <td colspan="4" valign="top">
                              <paragraph>
                                 <content styleCode="bold">SULFADIMETHOXINE</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="4" valign="top"/>
                           <td colspan="4" valign="top">
                              <paragraph>SOLUBLE POWDER</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="8" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Dosage and Administration:</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Species</content>
                              </paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Concentration</content>
                              </paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Use of Directions</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>Chickens</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>0.050%</paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>Contents of packet to 50 gal of water</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>Turkeys</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>0.025%</paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>Contents of packet to 100 gal of water</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="8" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Automatic Proportioners:</content> To make stock solution, add contents of 5 packets to 2 gal of water for chickens and to 4 gal of water for turkeys. Set proportioner to feed at a rate of 1 fl oz stock solution per gal of water.</paragraph>
                              <paragraph>
                                 <content styleCode="bold">Treatment Period: 6 consecutive days</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="8" valign="top">
                              <paragraph/>
                              <paragraph>
                                 <content styleCode="bold">Dairy Calves, Dairy Heifers, and Beef Cattle</content>
                              </paragraph>
                              <paragraph>
                                 <content styleCode="bold">Dosage:</content> 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="5" valign="top"/>
                           <td colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Sulfadimethoxine in Water</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="5" valign="top"/>
                           <td colspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Water Consumption</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top"/>
                           <td colspan="4" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Amount of Stock Solution </content>
                              </paragraph>
                              <paragraph>
                                 <content styleCode="bold">for Cattle*</content>
                              </paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>
                                 <content styleCode="bold">(Summer)*</content>
                              </paragraph>
                              <paragraph>
                                 <content styleCode="bold">1 gal/100 lb body weight**</content>
                              </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">(Winter)*</content>
                              </paragraph>
                              <paragraph>
                                 <content styleCode="bold">1 gal/150 lb body weight**</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td rowspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">First Day Add</content>
                              </paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>1 qt</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>10 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>  7 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>2 qt</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>20 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>14 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>1 gal</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>40 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>28 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td rowspan="3" valign="top">
                              <paragraph>
                                 <content styleCode="bold">Next 4 Days Add</content>
                              </paragraph>
                           </td>
                           <td colspan="2" valign="top">
                              <paragraph>1 qt</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>20 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>14 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>2 qt</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>40 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>28 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="2" valign="top">
                              <paragraph>1 gal</paragraph>
                           </td>
                           <td colspan="4" valign="top">
                              <paragraph>80 gal</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>56 gal</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="8" valign="top">
                              <paragraph>
                                 <content styleCode="bold">*Note:</content> Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water.</paragraph>
                              <paragraph>*Twenty fl oz of cattle stock solution will medicate 1-600 lb animal initially or 2-600 lb animals on maintenance dose. Contents of packet will medicate 6-600 lb animals initially or 12-600 lb animals on maintenance dose.</paragraph>
                              <paragraph>**This dosage recommendation is based on a water consumption of 1 gal per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30%-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake.</paragraph>
                              <paragraph>For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.</paragraph>
                              <paragraph>
                                 <content styleCode="bold">Treatment Period: 5 consecutive days</content>
                              </paragraph>
                           </td>
                        </tr>
                     </tbody>
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                  <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>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">Chickens and Turkeys</content> - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily.  Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication.  Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.</paragraph>
                  <paragraph>
                     <content styleCode="italics">Cattle </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/>
                  <paragraph>
                     <content styleCode="bold">WARNINGS:</content>
                     <br/>
                     <content styleCode="italics">Chickens</content> and <content styleCode="italics">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.</paragraph>
                  <paragraph>
                     <content styleCode="italics">Cattle </content>- Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only.</paragraph>
                  <paragraph>
                     <content>A withdrawal period has not been established for this product in pre-ruminating calves.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Do Not Use in Calves to be Processed For Veal</content>
                  </paragraph>
                  <paragraph/>
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               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
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                  <paragraph>
                     <content styleCode="bold">CONTACT INFORMATION:</content> To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472.   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>SULFASOL is a trademark of Med-Pharmex, Inc.</paragraph>
                  <paragraph/>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>Dechra Veterinary Products, LLC<br/>Overland Park, KS 66211</paragraph>
                  <paragraph/>
                  <paragraph/>
                  <paragraph>
                     <content>Rev. 05/2023</content>
                  </paragraph>
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