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   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <title>NEOSOL™ Soluable Powder</title>
   <effectiveTime value="20260403"/>
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            <name>Dechra Veterinary Products, LLC</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="17033-417" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>NEOSOL</name>
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                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Neomycin Sulfate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator value="50" unit="g"/>
                              <denominator value="100" unit="g"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="057Y626693" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>NEOMYCIN SULFATE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="I16QD7X297" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>NEOMYCIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
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                           <quantity>
                              <numerator value="22600" unit="g"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">(neomycin sulfate)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Antibacterial</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: </content>
                     <content>﻿Federal law restricts this drug to use by or on the order of a licensed veterinarian.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR USE IN ANIMALS ONLY KEEP OUT OF REACH OF CHILDREN</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"/>
                  </paragraph>
                  <paragraph>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.</paragraph>
                  <paragraph/>
                  <paragraph>Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin</paragraph>
                  <paragraph/>
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                  <paragraph>
                     <content styleCode="bold">Restricted Drug - Use only as Directed (California)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Oral Use in Animals Only</content>
                  </paragraph>
                  <paragraph>Add to drinking water - Not for use in liquid supplements.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dosage and Administration:</content> Administer 10 mg neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Using measuring spoons, the recommended dosage can be determined as follows:</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Daily Schedule for Drinking Water</content>
                  </paragraph>
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                     <tbody>
                        <tr>
                           <td colspan="2">
                              <paragraph>
                                 <content styleCode="bold">SWINE</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>One tablespoonful* of Neosol</paragraph>
                              <paragraph>Solubel Powder added to water</paragraph>
                              <paragraph>consumed in one day will treat</paragraph>
                           </td>
                           <td>
                              <paragraph> Weight of each pig</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>50 pigs </paragraph>
                           </td>
                           <td>
                              <paragraph>10 pounds</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>20 pigs</paragraph>
                           </td>
                           <td>
                              <paragraph>25 pounds </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>10 pigs</paragraph>
                           </td>
                           <td>
                              <paragraph>50 pounds </paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
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                     <tbody>
                        <tr>
                           <td colspan="2">
                              <paragraph>
                                 <content styleCode="bold">CATTLE (Not to be used in veal calves)</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>One tablespoonful* of Neosol<br/> Solubel Powder added to water or<br/>  milk consumed in one day will treat</paragraph>
                           </td>
                           <td>
                              <paragraph> Weight of calf</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph> 10 calves</paragraph>
                           </td>
                           <td>
                              <paragraph>  50 pounds</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>  7 calves  </paragraph>
                           </td>
                           <td>
                              <paragraph>  75 pounds </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <paragraph>  4 calves </paragraph>
                           </td>
                           <td>
                              <paragraph>125 pounds </paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content>* Level Tablespoonful = US Standard Measure</content>
                  </paragraph>
                  <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 stock solution, add six level tablespoonfuls to one gallon of water. Each pint of this stock solution will medicate 5 gallons of drinking water. For use in Automatic Proportioners delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoonfuls in a gallon of water to make the stock solution.</paragraph>
                  <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>
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               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="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<br/>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. 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. Animals not drinking or eating should be treated individually by drench.</paragraph>
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                     <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Warning:</content> Not for human use. Keep out of reach of children.</paragraph>
                        <paragraph>Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species.</paragraph>
                        <paragraph>Cattle...............................................................................1 day<br/>Swine and goats ............................................................3 days<br/>Sheep.............................................................................2 days</paragraph>
                        <paragraph>A withdrawal period has not been established for this product in pre-rumination 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.</paragraph>
                        <paragraph>Do not use in female dairy cattle 20 months of age or older.</paragraph>
                        <paragraph>Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.</paragraph>
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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.</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>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>Store in a dry place. When storing partially used containers, securely close bags to prevent contents from caking.</paragraph>
                  <paragraph>
                     <content styleCode="bold">KEEP CONTAINER TIGHTLY CLOSED. STORE AT ROOM TEMPERATURE</content>
                  </paragraph>
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               <text>
                  <paragraph>Approved by FDA under ANADA # 200-235</paragraph>
                  <paragraph>Manufactured for: Dechra Veterinary Products, Overland Park, KS 66211 USA</paragraph>
                  <paragraph>NEOSOL is a trademark of Med-Pharmex, Inc.</paragraph>
                  <paragraph>Rev. March 2023</paragraph>
               </text>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL </title>
               <text>
                  <paragraph>NDC 17033-417-50</paragraph>
                  <paragraph>
                     <content styleCode="bold">NEOSOL™ Soluble Powder</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content>(neomycin sulfate)</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Antibacterial</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">FOR USE IN ANIMALS ONLY KEEP OUT OF REACH OF CHILDREN</content>
                  </paragraph>
                  <paragraph>For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin</content>
                  </paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-235</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Weight: 50 lbs (22.6 kg)</content>
                  </paragraph>
                  <paragraph>Dechra</paragraph>
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                     <text>NEOSOL Label</text>
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