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            <name>Bimeda, Inc.</name>
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                        <code code="61133-5442" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>NeoMed 325</name>
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                              <name>neomycin sulfate</name>
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                              <denominator value="0.454" unit="kg"/>
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                              <name>NEOMYCIN SULFATE</name>
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                                    <code code="I16QD7X297" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>Neomycin</name>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>100 g pouch</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NeoMed® 325</content>
                     <br/>
                     <content styleCode="bold">(<content styleCode="italics">neomycin sulfate</content>)</content>
                     <br/>
                     <content styleCode="bold">Soluble Powder (Commercial Grade)</content>
                     <br/>
                     <content styleCode="bold">FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS &amp; TURKEYS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For the treatment and control of colibacillosis (bacterial enteritis) caused by <content styleCode="italics">Escherichia coli</content> susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.</content>
                     <br/>
                     <content styleCode="bold">For the control of mortality associated with<content styleCode="italics"> Escherichia coli</content> organisms susceptible to neomycin sulfate in growing turkeys.</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">Antibacterial</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Each Packet Contains:</content> 71.4 g neomycin sulfate (commercial grade) equivalent to 50 g neomycin.</paragraph>
                  <paragraph>
                     <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>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-050</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET WEIGHT:</content>
                     <br/>
                     <content styleCode="bold">100 g (3.5 oz)</content>
                  </paragraph>
               </text>
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               <title>100 g pouch</title>
               <text>
                  <paragraph>Add to drinking water - Not for use in liquid supplements.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DOSAGE AND ADMINISTRATION:</content> Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days.<br/>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Herd/Flock Treatment:</content> Each packet will treat 7,150 pounds body weight. Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion thereof) for each 7,150 pounds. The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.<br/>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Individual Animal Treatment:</content> To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.<br/>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Drinking Water: Swine</content> Use the number of packets indicated below in 256 gallons of water, or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.</paragraph>
                  <table width="40%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td> Pigs Weighing 25 to 50 Pounds</td>
                           <td> 2 Packets</td>
                        </tr>
                        <tr>
                           <td> Pigs Weighing 50 to 100 Pounds</td>
                           <td> 3 Packets</td>
                        </tr>
                        <tr>
                           <td> Pigs Weighing Over 100 Pounds</td>
                           <td> 4 Packets</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>200 g Pouch</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NeoMed® 325</content>
                     <br/>
                     <content styleCode="bold">(<content styleCode="italics">neomycin sulfate</content>)</content>
                     <br/>
                     <content styleCode="bold">Soluble Powder (Commercial Grade)</content>
                     <br/>
                     <content styleCode="bold">FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS &amp; TURKEYS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For the treatment and control of colibacillosis (bacterial enteritis) caused by<content styleCode="italics"> Escherichia coli</content> susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.</content>
                     <br/>
                     <content styleCode="bold">For the control of mortality associated with <content styleCode="italics">Escherichia coli</content> organisms susceptible to neomycin sulfate in growing turkeys.</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">Antibacterial</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Each Packet Contains: </content>142.8 g neomycin sulfate (commercial grade) equivalent to 100 g neomycin.<br/>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <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>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-050</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET WEIGHT:</content>
                     <br/>
                     <content styleCode="bold">200 g (7 oz)</content>
                  </paragraph>
               </text>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>200 g Pouch</title>
               <text>
                  <paragraph>Add to drinking water - Not for use in liquid supplements.<br/>
                     <content styleCode="bold">DOSAGE AND ADMINISTRATION:</content> Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days.<br/>
                     <content styleCode="bold">Herd/Flock Treatment:</content> Each packet will treat 14,300 pounds body weight. Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion thereof) for each 14,300 pounds. The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.<br/>
                     <content styleCode="bold">Individual Animal Treatment:</content> To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.<br/>
                     <content styleCode="bold">Drinking Water: Swine</content> Use the number of packets indicated below in 256 gallons of water, or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.</paragraph>
                  <table width="40%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td> Pigs Weighing 25-50 Pounds</td>
                           <td> 1 Packet</td>
                        </tr>
                        <tr>
                           <td> Pigs Weighing 50 to 100 Pounds</td>
                           <td> 1.5 Packets</td>
                        </tr>
                        <tr>
                           <td> Pigs Weighing Over 100 Pounds</td>
                           <td> 2 Packets</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>50 Pounds</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NeoMed® 325</content>
                     <br/>
                     <content styleCode="bold">(<content styleCode="italics">neomycin sulfate</content>)</content>
                     <br/>
                     <content styleCode="bold">Soluble Powder (Commercial Grade)</content>
                     <br/>
                     <content styleCode="bold">FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS &amp; TURKEYS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For the treatment and control of colibacillosis (bacterial enteritis) caused by<content styleCode="italics"> Escherichia coli</content> susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.</content>
                     <br/>
                     <content styleCode="bold">For the control of mortality associated with <content styleCode="italics">Escherichia coli</content> organisms susceptible to neomycin sulfate in growing turkeys.</content>
                     <br/>
                     <content styleCode="italics">
                        <content styleCode="bold">Antibacterial</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Each Pound Contains: </content>325 g neomycin sulfate (commercial grade) equivalent to 227.5 g neomycin.</paragraph>
                  <paragraph>
                     <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>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under ANADA # 200-050</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NET WEIGHT:</content>
                     <br/>
                     <content styleCode="bold">50 Pounds (22.7 kg)</content>
                  </paragraph>
               </text>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>50 Pounds</title>
               <text>
                  <paragraph/>
                  <paragraph>Add to drinking water - Not for use in liquid supplements.<content styleCode="bold">
                        <br/>Dosage and Administration: </content>Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days. Using measuring spoons, the recommended dosage can be determined as follows:</paragraph>
                  <paragraph>
                     <content styleCode="bold">Daily Schedule For Drinking Water:</content>
                  </paragraph>
                  <table width="40%">
                     <caption>SWINE </caption>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold"> One level tablespoon of NeoMed 325 added to water consumed in one day will treat</content>
                           </td>
                           <td>
                              <content styleCode="bold">Weight of each pig </content>
                           </td>
                        </tr>
                        <tr>
                           <td> 50 pigs</td>
                           <td> 10 pounds</td>
                        </tr>
                        <tr>
                           <td> 20 pigs</td>
                           <td> 25 pounds</td>
                        </tr>
                        <tr>
                           <td> 10 pigs</td>
                           <td> 50 pounds</td>
                        </tr>
                     </tbody>
                  </table>
                  <table width="40%">
                     <caption>CATTLE </caption>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold">One level tablespoon of NeoMed 325 added to water consumed in one day will treat</content>
                           </td>
                           <td>
                              <content styleCode="bold">Weight of each calf </content>
                           </td>
                        </tr>
                        <tr>
                           <td> 10 calves</td>
                           <td> 50 pounds</td>
                        </tr>
                        <tr>
                           <td> 7 calves</td>
                           <td> 75 pounds</td>
                        </tr>
                        <tr>
                           <td> 4 calves</td>
                           <td> 125 pounds</td>
                        </tr>
                     </tbody>
                  </table>
                  <table width="40%">
                     <caption>TURKEYS </caption>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold"> One level tablespoon of NeoMed 325 added to water consumed in one day will treat</content>
                           </td>
                           <td>
                              <content styleCode="bold">Weight of each bird </content>
                           </td>
                        </tr>
                        <tr>
                           <td> 1000 birds</td>
                           <td> 0.5 pounds</td>
                        </tr>
                        <tr>
                           <td> 500 birds</td>
                           <td> 1 pounds</td>
                        </tr>
                        <tr>
                           <td> 100 birds</td>
                           <td> 5 pounds</td>
                        </tr>
                        <tr>
                           <td> 50 birds</td>
                           <td> 10 pounds</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day. For a <content styleCode="bold">stock solution,</content> add six level tablespoons to one gallon of water. Each pint of this stock solution will medicate 5 gallons of drinking water.<br/>For use in <content styleCode="bold">Automatic Proportioners</content> delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoons in a gallon of water to make the stock solution.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Individual Animal Treatment</content>: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.</paragraph>
               </text>
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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> To administer the stated dosage, the concentration of neomycin required in medicated water must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.</paragraph>
                  <paragraph>If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. If symptoms such as fever, depression, or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Important:</content> Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days for cattle, swine, sheep and goats and 5 days for turkeys. Animals not drinking or eating should be treated individually by drench.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Warning:</content> Not for human use. Keep out of reach of children.</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20240328"/>
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               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Residue Warnings:</content> Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:</paragraph>
                  <table width="30%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td> Cattle </td>
                           <td> 1 day</td>
                        </tr>
                        <tr>
                           <td> Swine and Goats</td>
                           <td> 3 days</td>
                        </tr>
                        <tr>
                           <td> Sheep</td>
                           <td> 2 days</td>
                        </tr>
                        <tr>
                           <td> Turkeys</td>
                           <td> 0 days</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.</paragraph>
                  <paragraph>The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.</paragraph>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>100 g and 200 g Pouches</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">When storing partially used packet, securely close protect from moisture. Store in a dry place.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Store at controlled room temperature 20°C-25°C (68°F-77°F), with excursions permitted to</content>
                     <br/>
                     <content styleCode="bold">15°C- 30°C (59°-86°F).</content>
                  </paragraph>
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               <title>50 Pounds</title>
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                     <content styleCode="bold">When storing partially used containers, securely close bags and keep container tightly closed to prevent contents from caking. Store in a dry place.</content>
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                     <content styleCode="bold">Store at controlled room temperature 20°C-25°C (68°F-77°F), with excursions permitted to</content>
                     <br/>
                     <content styleCode="bold">15°C- 30°C (59°-86°F).</content>
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