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   <title>NEOSOL ORAL
(neomycin sulfate)</title>
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            <name>Med-Pharmex, Inc</name>
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               <text>
                  <paragraph>
                     <content styleCode="bold">ANADA #200-289, Approved by FDA</content>
                     <br/>
                     <br/>  <content styleCode="bold">Antibacterial</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR ORAL USE ONLY</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">FOR ANIMAL USE ONLY</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                     <br/>
                     <br/>
                     <content styleCode="bold">Net Contents 1 </content>
                     <content styleCode="bold">Pint (473 mL) <br/>
                     </content>(NDC # 54925-043-47)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents 1 </content>
                     <content styleCode="bold">Gallon (3.785 L) <br/>
                     </content>(NDC # 54925-043-11)</paragraph>
                  <paragraph>
                     <content styleCode="underline">
                        <content styleCode="bold">
                           <content styleCode="bold">MED-</content>
                        </content>PHARMEX</content>
                     <content styleCode="bold">
                        <content styleCode="bold"/>
                        <br/>INCORPORATED <br/>POMONA, CA 91767</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted Drug (California) - Use Only as Directed.<br/>                 Not for Human use.</content>
                  </paragraph>
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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">INDICATIONS</content>: 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>For the control of mortallty associated with <content styleCode="italics">Escherichia coli<content styleCode="italics">
                           <content styleCode="bold">
                              <content styleCode="bold">  </content>
                           </content>
                        </content>
                     </content>organisms susceptible to neomycin sulfate in growing turkeys.</paragraph>
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                        <code code="54925-043" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>NEOSOL ORAL<suffix/>
                        </name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Neomycin Sulfate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <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>
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                              <numerator value="473" unit="mL"/>
                              <denominator value="1"/>
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                              <numerator value="3785" unit="mL"/>
                              <denominator value="1"/>
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                           <statusCode code="active"/>
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                        <approval>
                           <id extension="ANADA200289" 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="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE AND ADMINISTRATION</content>: 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. Administer to turkeys at a dose 10 mg neomycin sulfate per pound of body weight per day for 5 days.</paragraph>
                  <paragraph>                                               Amount of NEOSOL Oral solution<br/>
                     <content styleCode="underline">Pounds of Body Weight             Per Day in Divided Doses</content>
                     <br/>     25 lbs                                   1.2 mL (1/4 teaspoonful)<br/>     50 lbs                                   2.5 mL (1/2 teaspoonful)<br/>     100 lbs                                 5 mL (1 teaspoonful)<br/>     300 lbs                                 15 mL (1 tablespoonful)<br/>     <content styleCode="underline">591.5 lbs                               29.5 mL (1 fluid ounce)</content>
                     <br/>Teaspoon = U.S. Standard Measure</paragraph>
                  <paragraph>NEOSOL ORAL solution may may be given undiluted or diluted with water.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents 1 Pint (473 mL) </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> HERD TREATMENT</content>: Each 473.1 mL (1 Pt.) will treat 9464 pounds of body weight. Therefore, estimate the total number of pounds of <br/>body weight of the animals to be treated and administer 29.5 mL (1 Fl. Oz.) for each 591.5 lbs. The product should be added to the amount <br/>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.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents 1 Gallon (3.785 L)</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">HERD TREATMENT</content>: Each 3.785 L (1 Gallon) will treat 75,700 pounds of body weight.  Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer 29.5 mL (1 Fl. Oz.) for each 591.5 lbs.  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.</paragraph>
                  <paragraph>
                     <content styleCode="bold">INDIVIDUAL ANIMAL TREATMENT</content>: To provide 10 mg neomycin sulfate per pound of body weight, mix 5 mL (1 tsp) in water or milk for each 100 lbs. of body weight. Administer daily either as a drench in divided dosages or in the drinking water to be consumed in 12-24 hours.</paragraph>
                  <paragraph>
                     <content styleCode="bold">COMPOSITION</content>: Each mL contains 200 mg of Neomycin Sulfate equivalent to 140 mg neomycin base.<content styleCode="underline"/>
                  </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">PRECAUTIONS</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.<br/>
                     <br/>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 poor absorption from the gastrointestinal tract.<br/>
                     <br/>
                     <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="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">RESIDUE WARNINGS:</content>
                     <br/>Discontinue treatment prior to slaughter follows:<br/>        <content styleCode="bold">Turkeys</content>
                     <content styleCode="bold"> -</content> 0 days<br/>        <content styleCode="bold">Cattle</content>
                     <content styleCode="bold">-</content> 1 day<br/>        <content styleCode="bold">Sheep</content>
                     <content styleCode="bold">- </content>2 days<br/>        <content styleCode="bold">Swine and Goats</content>
                     <content styleCode="bold"> -</content> 3 days<br/>
                  </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.<br/>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>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Controlled Room Temperature 15</content>
                     <content>°</content>
                     <content styleCode="bold">C</content>
                     <content styleCode="bold"> to 30</content>
                     <content>°</content>
                     <content styleCode="bold">C (59</content>
                     <content>°</content>
                     <content styleCode="bold"> to 86</content>
                     <content>°</content>
                     <content styleCode="bold">F) </content>
                     <br/>
                     <br/>
                     <content styleCode="bold">TAKE TIME OBSERVE LABEL DIRECTIONS</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Lot #/Exp. Date</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"/>rev. 08/12</paragraph>
               </text>
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                     <text>Neosol Oral 1 Pint label</text>
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