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                        <name>Sulfadimethoxine Concentrated Solution 12.5%</name>
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                                    <name>SULFADIMETHOXINE</name>
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                              <numerator value="3.8" unit="L"/>
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                  <paragraph>
                     <content styleCode="bold">Sulfadimethoxine 12.5%</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">(sulfadimethoxine)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CONCENTRATED SOLUTION 12.5%</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTI</content>
                     <content styleCode="bold">ON: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Antibacterial for use in drinking water</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Oral Use in Chickens, Turkeys and Cattle</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">3.75 g sulfadimethoxine/fl oz</content>
                     <br/>
                     <content styleCode="bold">Protect From Light</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-030</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET CONTENTS:<br/>3.8 L<br/>(1 GALLON)</content>
                  </paragraph>
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                  <paragraph>
                     <content styleCode="bold">INDICATIONS:</content>
                     <br/>
                     <content styleCode="bold">BROILER AND REPLACEMENT CHICKENS–</content> Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.<br/>
                     <content styleCode="bold">MEAT PRODUCING TURKEYS–</content> Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.<br/>
                     <content styleCode="bold">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">Fusobacterium necrophorum</content> (<content styleCode="italics">Sphaerophorus necrophorus</content>) sensitive to sulfadimethoxine.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">PRECAUTION:</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">CHICKENS AND TURKEYS–</content> If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. 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="bold">CATTLE–</content> During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>
                     <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">CATTLE–</content> Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">STORE AT CONTROLLED ROOM TEMPERATURE 20-25°C (68-77°F).</content>
                     <br/>
                     <content styleCode="bold">NOT FOR USE IN HUMANS</content>
                     <br/>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                     <br/>
                     <content styleCode="bold">Restricted Drug (California) – Use Only as Directed</content>
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               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <text>
                  <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>Aspen Veterinary Resources<sup>®</sup>, Ltd.<br/>Liberty, MO 64068<br/>www.aspenveterinaryresources.com</paragraph>
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                     <content styleCode="bold">LOT NO.:                              EXP. DATE:</content>
                  </paragraph>
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                     <text>Take Time</text>
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                  <paragraph>
                     <content styleCode="bold">Dosage and Administration</content>
                  </paragraph>
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                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Chickens and Turkeys</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Treatment Period: 6 consecutive days</content>
                              </paragraph>
                           </td>
                           <td/>
                           <td/>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Recommended Concentration: </content>Chickens – 0.05%; Turkeys <content styleCode="bold">– </content>0.025%</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Chickens</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>Add 1 fl oz (30 mL) to 2 gal of drinking water or 25 fl oz to 50 gal of drinking water.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Turkeys</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>Add 1 fl oz (30 mL) to 4 quarts of drinking water or 25 fl oz to 100 gal of drinking water.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Automatic Proportioners *Stock Solution </content>– To make 2 gal of stock solution:</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Chickens</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>Add 1 gal of Sulfadimethoxine Concentrated Solution 12.5% to 1 gal of water.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Turkeys</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>Add 2 gal of Sulfadimethoxine Concentrated Solution 12.5% to 6 qt of water</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>*Set proportioner to a feed rate of 1 fl oz of stock solution per gal of water</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Dairy Calves, Dairy Heifers, and Beef Cattle</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Treatment Period: 5 consecutive days</content>
                              </paragraph>
                           </td>
                           <td/>
                           <td/>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Dosage:</content> Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day.</paragraph>
                              <paragraph>
                                 <content styleCode="bold">Summer Administration</content>
                              </paragraph>
                              <paragraph>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/>
                           <td>
                              <paragraph>
                                 <content styleCode="bold"> Sulfadimethoxine Concentrated Solution 12.5%</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Daily Drinking Water Supply</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Initial Dose</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Maintenance Dose</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>25 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 pt (16 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>1 cup (8 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>50 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 qt (32 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>1 pt (16 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>200 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 gal (128 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>2 qt (64 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Winter Administration</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>Dosage recommendations for winter 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/>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Sulfadimethoxine Concentrated Solution 12.5%</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Daily Drinking Water Supply</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Initial Dose</content>
                              </paragraph>
                           </td>
                           <td>
                              <paragraph>
                                 <content styleCode="bold">Maintenance Dose</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>16 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 pt (16 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>1 cup (8 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>33 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 qt (32 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>1 pt (16 fl oz)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>127 gal</paragraph>
                           </td>
                           <td>
                              <paragraph>1 gal (128 fl oz)</paragraph>
                           </td>
                           <td>
                              <paragraph>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.</paragraph>
                              <paragraph>Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day.</paragraph>
                              <paragraph>One fl oz will medicate one 150-lb animal initially and ½ fl oz will dedicate one 150-lb animal on maintenance dose.</paragraph>
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