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   <title>RofenAid 40<br/>
   </title>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="54771-1446" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Rofenaid 40</name>
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                              <name>Sulfadimethoxine and Ormetoprim</name>
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                              <name>SULFADIMETHOXINE</name>
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                                    <name>SULFADIMETHOXINE</name>
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                                    <name>ORMETOPRIM</name>
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                              <originalText>beige to light tan</originalText>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION</title>
               <text>
                  <paragraph>RofenAid<br/>40</paragraph>
                  <paragraph>Sulfadimethoxine &amp; Ormetoprim</paragraph>
                  <paragraph>Type A Medicated Article </paragraph>
                  <paragraph>Antibacterial</paragraph>
                  <paragraph>Anticoccidial</paragraph>
                  <paragraph>For use in broiler, replacement (breeder and layer) chickens, turkeys, ducks and chukar partridges only.</paragraph>
               </text>
               <effectiveTime value="20190320"/>
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               <title>Active Drug Ingredients</title>
               <text>
                  <paragraph>Sulfadimethoxine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.5 grams per pound (25%),</paragraph>
                  <paragraph>Ormetoprim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.1 grams per pound (15%)</paragraph>
                  <paragraph>in a carrier suitable for incorporation in feed.</paragraph>
                  <paragraph>
                     <content styleCode="bold">For use in manufacturing medicated feeds only</content>
                  </paragraph>
               </text>
               <effectiveTime value="20170512"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Chickens<br/>
               </title>
               <text>
                  <paragraph>Broiler and replacement (breeder and layer) chickens</paragraph>
                  <paragraph>
                     <content styleCode="bold">Indications:</content>
                     <br/>
                  </paragraph>
                  <paragraph>As an aid in the prevention of coccidiosis caused by <content styleCode="italics">Eimeria tenella, E. necatrix, E. acervulina, </content>
                     <content styleCode="italics">E. maxima, E. brunetti </content>and <content styleCode="italics">E. mivati; </content>as an aid in the prevention of bacterial infections caused by <content styleCode="italics">Haemophilus gallinarum </content>(infectious coryza), <content styleCode="italics">Escherichia coli </content>(colibacillosis) and <content styleCode="italics">Pasteurella </content>
                     <content styleCode="italics">multocida </content>(fowl cholera).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Use directions:</content>
                  </paragraph>
                  <paragraph>Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Warning:</content>
                  </paragraph>
                  <paragraph>Do not feed to chickens over 16 weeks (112 days) of age.</paragraph>
               </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Turkeys</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Indications:</content>
                  </paragraph>
                  <paragraph>As an aid in the prevention of coccidiosis caused by <content styleCode="italics">Eimeria adenoeides, E. gallopavonis, </content>and <content styleCode="italics">E. meleagrimitis; </content>for the prevention of bacterial infections caused by <content styleCode="italics">Pasteurella multocida </content>(fowl cholera).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Use directions:</content>
                  </paragraph>
                  <paragraph>Add 1/2 lb of RofenAid 40 to one ton of feed to provide 0.01% (56.75 g/ton [0.00625%] sulfadimethoxine and 34.05 g/ton [0.00375%] ormetoprim) concentration in feed. Feed continuously as the sole ration.</paragraph>
               </text>
               <effectiveTime value="20190320"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Ducks</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Ducks, including breeding ducks</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> </content>
                     <content styleCode="bold">Indications:</content>
                  </paragraph>
                  <paragraph>As an aid in the control of bacterial infections due to <content styleCode="italics">Pasteurella multocida </content>(fowl cholera) in ducks including breeding ducks.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Use directions:</content>
                  </paragraph>
                  <paragraph>Add 2 lbs of RofenAid 40 to one ton of feed to provide 0.04% (227 g/ton [0.025%] sulfadimethoxine and 136.2 g/ton [0.015%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.</paragraph>
                  <paragraph>
                     <content styleCode="bold"> </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Ducks</content>
                     <br/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Indications:</content>
                  </paragraph>
                  <paragraph>As an aid in the control of bacterial infections due to <content styleCode="italics">Escherichia coli, Riemerella anatipestifer </content>(strains 2, 3 &amp; 4) and severe challenge of <content styleCode="italics">P. multocida </content>(fowl cholera).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Use directions:</content>
                  </paragraph>
                  <paragraph>Add 4 lbs of RofenAid 40 to one ton of feed to provide 0.08% (454 g/ton [0.050%] sulfadimethoxine and 272.4 g/ton [0.030%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content>
                  </paragraph>
                  <paragraph>Not for breeding ducks. The safety of feeding sulfadimethoxine and ormetoprim at levels higher than 0.025% and 0.015%, respectively, in breeding ducks has not been established.</paragraph>
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               <title>Chukar Partridges</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Indications:</content>
                     <br/>
                  </paragraph>
                  <paragraph>For the prevention of coccidiosis caused by <content styleCode="italics">Eimeria kofoidi </content>and <content styleCode="italics">E. legionensis.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Use directions:</content>
                  </paragraph>
                  <paragraph>Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration to young birds up to 8 weeks of age.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution</content>:</paragraph>
                  <paragraph>The safety of feeding RofenAid 40 to breeding stock has not been established.</paragraph>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warning<br/>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Do not feed to turkeys and ducks producing eggs for food. Withdraw 5 days </content>
                     <content styleCode="bold">prior to slaughter of broiler and replacement chickens, turkeys and ducks.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20190320"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Note</title>
               <text>
                  <paragraph>Manufacture of Type B or C feeds from this product requires a Medicated Feed Mill License.<br/>
                     <br/>Labels for feeds containing RofenAid 40 must contain appropriate indications, limitations and warnings as well as required feed ingredient information.</paragraph>
               </text>
               <effectiveTime value="20200407"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Restricted Drug (California) - Use only as directed. Not for human use.<br/>Approved by FDA under NADA # 040-209<br/>Store below 25°C (77°F), excursions permitted to 37°C (99°F).<br/>
                     <br/>zoetis<br/>
                     <br/>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007<br/>
                     <br/>Product of China<br/>
                     <br/>10010602</paragraph>
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                     <text>Bag label</text>
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