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   <title>NEOMYCIN LIQUID</title>
   <effectiveTime value="20180212"/>
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            <name>Sparhawk Laboratories, Inc.</name>
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               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="58005-105" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Neomycin</name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Neomycin</name>
                           </genericMedicine>
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                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator value="140" unit="mg"/>
                              <denominator value="1" unit="mL"/>
                           </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>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="473" unit="mL"/>
                              <denominator value="1"/>
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                           <quantity>
                              <numerator value="3823" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
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                        <marketingAct>
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                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20070731"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="ANADA200379" root="2.16.840.1.113883.3.150"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Neomycin Sulfate</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Antibacterial</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR ANIMAL USE ONLY</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                  </paragraph>
                  <paragraph>Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by <content styleCode="italics">Escherichia coli </content>susceptible to neomycin sulfate in cattle, swine, sheep and goats.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin</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>Restricted Drug-Use Only As Directed (California)</paragraph>
                  <paragraph>For Oral Use in Animals only.</paragraph>
                  <paragraph>Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by <content styleCode="italics">﻿Escherichia coli </content>﻿susceptible to neomycin sulfate in cattle, swine, sheep and goats.</paragraph>
                  <paragraph>
                     <content>ANADA#: 200-379 Approved by F.D.A.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20180112"/>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Dosage and Administration</title>
               <text>
                  <paragraph>Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.</paragraph>
                  <paragraph>
                     <content styleCode="bold">       Dosage Schedule for treatment of colibacillosis:</content>
                  </paragraph>
                  <paragraph>   Pounds of                               Amount of Neomycin Liquid</paragraph>
                  <paragraph>
                     <content styleCode="underline"> Body Weight                              </content>
                     <content styleCode="underline">Per Day in Divided Doses   </content>
                  </paragraph>
                  <paragraph>      25 lbs                                           1/4 teaspoonful<br/>      50 lbs                                           1/2 teaspoonful<br/>    100 lbs                                            1 teaspoonful<br/>    300 lbs                                            1 tablespoonful<br/>    600 lbs                                            1 fluid ounce</paragraph>
                  <paragraph>Teaspoon = U.S. Standard Measure</paragraph>
                  <paragraph>Neomycin Liquid may be given undiluted or diluted with water.</paragraph>
                  <paragraph>Herd Treatment: Each bottle will treat 9,600 pounds body weight. Therefore, estimate the total number of pounds body weight of the animals to be treated and administer on (1) fluid ounce for each 600 pounds. The product should be added to the amount of drinking water 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.</paragraph>
                  <paragraph>Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) teaspoon in water or milk for each 100 pounds 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"/>
               <title>Precautions</title>
               <text>
                  <paragraph>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.<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20160825"/>
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               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
               <text>
                  <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. Animals not drinking or eating should be treated individually by drench.</paragraph>
               </text>
               <effectiveTime value="20180112"/>
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               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <title>Warnings</title>
               <text>
                  <paragraph>Not for human use. Keep out of reach of children. Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:</paragraph>
                  <paragraph>   Cattle .............................................. 1 day</paragraph>
                  <paragraph>   Sheep ............................................ 2 days</paragraph>
                  <paragraph>   Swine and Goats ............................. 3 days</paragraph>
                  <paragraph>Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues. </paragraph>
                  <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.</paragraph>
                  <paragraph>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.</paragraph>
               </text>
               <effectiveTime value="20180112"/>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>Store at controlled room temperature 20<sup>o</sup> to 25<sup>o</sup>C (68<sup>o</sup> to 77<sup>o</sup>F) (see USP)</paragraph>
                  <paragraph>
                     <content styleCode="bold">TAKE TIME OBSERVE LABEL DIRECTIONS</content>
                  </paragraph>
               </text>
               <effectiveTime value="20180112"/>
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                     <text>SLI Neomycin Liquid Unit</text>
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