<text/> <effectiveTime value="20190913"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="23243-6771" codeSystem="2.16.840.1.113883.6.69"/> <name>Sul-Q-Nox</name> <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Solution"/> <asEntityWithGeneric> <genericMedicine> <name>sulfaquinoxaline</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value=".3192" unit="g"/> <denominator value="1" unit="mL"/> </quantity> <ingredientSubstance> <code code="WNW8115TM9" codeSystem="2.16.840.1.113883.4.9"/> <name>SULFAQUINOXALINE</name> <activeMoiety> <activeMoiety> <code code="WNW8115TM9" codeSystem="2.16.840.1.113883.4.9"/> <name>SULFAQUINOXALINE</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="3785" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <formCode code="C43233" displayName="PACKAGE" codeSystem="2.16.840.1.113883.3.26.1.1"/> <asContent> <quantity> <numerator value="4" unit="1"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="23243-6771-2" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43178" displayName="BOX" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <approval> <id extension="NADA006891" root="2.16.840.1.113883.3.150"/> <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20190709"/> </effectiveTime> </marketingAct> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="L01cfba05-12e3-4765-8560-8bc14998d9d5"> <id root="556015a3-fbcd-4372-96d7-06c8b1fa8f98"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold">Sul-Q-Nox®</content> </paragraph> <paragraph> <content styleCode="bold">31.92% (Sulfaquinoxaline as sodium and potassium salts)</content> </paragraph> <paragraph>ANTIMICROBIAL</paragraph> </text> <effectiveTime value="20231006"/> </section> </component> <component> <section ID="Ldc0a1dd5-5048-4adc-9f49-d2daf6210e6b"> <id root="81ee2ca3-8f48-4c73-aac5-7e82744ad26d"/> <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">Caution: Federal (USA) law restricts this drug to use by or on the</content> <br/> <content styleCode="bold">order of a licensed veterinarian.</content> <br/> <content styleCode="bold">For Use in Animal Drinking Water Only</content> <br/> <content styleCode="bold">Sulfonamide</content> </paragraph> <paragraph> <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content> <br/> <content styleCode="bold">KEEP TIGHTLY SEALED WHEN NOT IN USE</content> </paragraph> <paragraph>Restricted Drug (California) - Use only as directed. Not for human use.</paragraph> <paragraph> <content styleCode="bold">Net Contents: 1 Gallon (128 fl. oz.)</content> </paragraph> </text> <effectiveTime value="20231006"/> </section> </component> <component> <section ID="Lff303ccb-7ec7-47d7-901d-ce208de18862"> <id root="71d17de2-a68b-4492-8d94-6114fc46c634"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph>Manufactured for:<br/>Huvepharma, Inc.<br/>525 Westpark Drive, Suite 230<br/>Peachtree City, GA 30269</paragraph> <paragraph> <content styleCode="bold">HUVEPHARMA®</content> </paragraph> <paragraph>HUVEPHARMA and Sul-Q-Nox are registered<br/>trademarks of Huvepharma EOOD</paragraph> <paragraph> <renderMultiMedia referencedObject="L80f20974-bf4c-41bd-80df-4cc8f1159fd0"/> </paragraph> <paragraph>Approved by FDA under NADA # 006-891<br/>P08-4001SL<br/>Rev. 01-2022</paragraph> </text> <effectiveTime value="20231006"/> <component> <observationMedia ID="L80f20974-bf4c-41bd-80df-4cc8f1159fd0"> <text>Take Time</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Take time.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="L623acd83-a3ac-4dd5-aee6-287a3652a789"> <id root="549261ab-4851-4fc1-b8be-7d0a41e8653c"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CAUTION:</content> </paragraph> <paragraph>• May cause toxic reactions unless drug is evenly mixed in water at dosages indicated and used according<br/>to directions.<br/>• Levels of sulfaquinoxaline higher than 0.025% in feed or 0.012% in water for more than 24 to 36 hours<br/>may result in reduced growth rate in chickens as a result of reduced feed or water intake.<br/>• For control of disease outbreaks, medication should be initiated as soon as diagnosis is determined.<br/>• Treated animals must actually consume enough medicated water to provide a necessary dosage of<br/>approximately 10 to 45 mg/lb/day in chickens and 3.5 to 55 mg/lb/day in turkeys and 6 mg/lb/day in<br/>cattle and calves, depending on class of animal, ambient temperature, age, and other factors.<br/>• Prolonged administration of sulfaquinoxaline at higher doses may result in depressed feed or water<br/>intake, deposition of sulfaquinoxaline crystals in kidney and interference with normal blood clotting.<br/>• Do not mix or administer in galvanized containers.<br/>• The follwing word is required on this product to comply with Agricultural Code of California:<br/>HAZARDOUS<br/>• CAUSES SKIN AND EYE BURNS. Avoid contact with eyes, skin, or clothing. In case of contact, flush<br/>immediately with water for at least 15 minutes; for eye get medical attention.</paragraph> </text> <effectiveTime value="20231006"/> </section> </component> <component> <section ID="Ld6aa5d28-e4ba-4e86-a231-9d66b3903c5d"> <id root="4b7fbacb-9ac0-4954-9d97-a617ae87726f"/> <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/> <text> <paragraph> <content styleCode="bold">WARNING:</content> </paragraph> <paragraph>• Withdraw use of product 10 days before slaughter.<br/>• A withdrawal period has not been established for this product in pre-ruminating<br/>calves. Do not use in calves to be processed for veal.<br/>• Do not medicate chickens or turkeys producing eggs for human<br/>consumption.<br/>• Not for use in lactating dairy cattle.<br/>• DISPOSE OF ANY WASTE OR UNUSED PORTION PROPERLY.<br/>• KEEP ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.<br/>• Store between 20°- 25°C (68°- 77°F); excursions permitted between<br/>15°- 40°C (59°- 104°F).</paragraph> </text> <effectiveTime value="20231006"/> </section> </component> <component> <section ID="L92b56893-bd4a-45fb-89c4-c9c8990abd53"> <id root="84914469-68bc-464f-8ee0-ce48db514ca8"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">FOR AUTOMATIC DRINKING WATER PROPORTIONERS</content> <br/>FOR CONTROL OR TREATMENT OF THE FOLLOWING DISEASES WHEN CAUSED BY ONE<br/>OR MORE PATHOGENIC ORGANISMS SUSCEPTIBLE TO SULFAQUINOXALINE<br/> <content styleCode="bold">PREPARE MEDICATED DRINKING WATER FRESH DAILY</content> </paragraph> <table width="100%"> <caption/> <tbody> <tr> <td> <content styleCode="bold"> INDICATIONS</content> </td> <td> <content styleCode="bold">DOSAGE PER 128 GALLONS OF</content> <br/> <content styleCode="bold">WATER</content> </td> <td> <content styleCode="bold"> TREATMENT</content> </td> </tr> <tr> <td rowspan="2"> <content styleCode="bold">COCCIDIOSIS — CHICKENS:</content> <br/>Control of coccidiosis caused by <content styleCode="italics">Eimeria tenella,</content> <br/> <content styleCode="italics">E. necatrix, E. maxima, E. brunetti, E. acervulina</content>,<br/>susceptible to sulfaquinoxaline. </td> <td> <content styleCode="bold">20½ fl. oz.</content> <br/> <content styleCode="bold">(0.04%)</content> </td> <td> <paragraph> Give for 2-3 days, skip 3 days.</paragraph> <paragraph> <content styleCode="bold"> Then</content> </paragraph> </td> </tr> <tr> <td> <content styleCode="bold">13 fl. oz.</content> <br/> <content styleCode="bold">(0.025%)</content> </td> <td>Give for 2 days more. If bloody droppings appear, repeat<br/>treatment at this level for 2 more days.<br/> <content styleCode="bold">CAUTION:</content> Do not change litter unless absolutely<br/>necessary. Do not give flushing mashes.</td> </tr> <tr> <td> <content styleCode="bold">COCCIDIOSIS — TURKEYS:</content> <br/>Control of coccidiosis caused by <content styleCode="italics">Eimeria</content> <br/> <content styleCode="italics">meleagrimitis, E. adenoeides</content>, susceptible to<br/>sulfaquinoxaline.</td> <td> <content styleCode="bold">13 fl. oz.</content> <br/> <content styleCode="bold">(0.025%)</content> </td> <td>Give for 2 days - skip 3 days - give for 2 days - skip 3 days<br/>and give 2 more days. Repeat if necessary.<br/> <content styleCode="bold">CAUTION:</content> Do not change litter unless absolutely<br/>necessary. Do not give flushing mashes.</td> </tr> <tr> <td> <content styleCode="bold">ACUTE FOWL CHOLERA — CHICKENS AND</content> <br/> <content styleCode="bold">TURKEYS:</content> <br/>Control of acute fowl cholera caused by<br/> <content styleCode="italics">Pasteurella multocida</content> susceptible to<br/>sulfaquinoxaline.<br/> <content styleCode="bold">FOWL TYPHOID — CHICKENS AND TURKEYS:</content> <br/>Control of fowl typhoid caused by <content styleCode="italics">Salmonella</content> <br/> <content styleCode="italics">gallinarum</content>, susceptible to sulfaquinoxaline.</td> <td> <content styleCode="bold">20½ fl. oz.</content> <br/> <content styleCode="bold">(0.04%)</content> </td> <td>Use for 2-3 days. Move birds to clean ground. If disease<br/>recurs, repeat treatment. Poultry that have survived fowl<br/>typhoid outbreaks should not be kept for laying house<br/>replacements or breeders unless tests show they are not<br/>carriers.</td> </tr> <tr> <td> <content styleCode="bold">COCCIDIOSIS — CATTLE AND CALVES:</content> <br/>For the control and treatment of coccidiosis<br/>caused by <content styleCode="italics">Eimeria bovis</content>,<content styleCode="italics"> E. zuernii</content>, susceptible<br/>to sulfaquinoxaline.</td> <td> <content styleCode="bold">7¾ fl. oz.</content> <br/> <content styleCode="bold">(0.015%)</content> <br/> <content styleCode="bold">6 mg/lb</content> <br/> <content styleCode="bold">of body wt.</content> </td> <td> <paragraph>Give for 3-5 days. As a generalization, cattle and calves<br/>will consume approx. 1 gal/100 lbs body weight/day. Cattle<br/>or calves not eating or drinking must be treated</paragraph> <paragraph>individually.</paragraph> </td> </tr> <tr> <td colspan="3"> <content styleCode="bold">To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, </content> <content styleCode="bold">Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, </content> <content styleCode="bold">contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</content> </td> </tr> </tbody> </table> <paragraph/> </text> <effectiveTime value="20231006"/> </section> </component> <component> <section ID="L4d72a8f1-45d9-4b49-b6c2-3ab4f1f49af9"> <id root="e176a78e-4d3c-42e2-aa6d-b56d897066d9"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="L0e1ebc4c-9751-4dc0-921d-ebf07d1f4409"/> </paragraph> </text> <effectiveTime value="20231006"/> <component> <observationMedia ID="L0e1ebc4c-9751-4dc0-921d-ebf07d1f4409"> <text>image description</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Sul-Q-Nox 1 gal bottle label.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>


               
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                              <name>SULFAQUINOXALINE</name>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
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                  <paragraph>
                     <content styleCode="bold">Sul-Q-Nox®</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">31.92% (Sulfaquinoxaline as sodium and potassium salts)</content>
                  </paragraph>
                  <paragraph>ANTIMICROBIAL</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Caution: Federal (USA) law restricts this drug to use by or on the</content>
                     <br/>
                     <content styleCode="bold">order of a licensed veterinarian.</content>
                     <br/>
                     <content styleCode="bold">For Use in Animal Drinking Water Only</content>
                     <br/>
                     <content styleCode="bold">Sulfonamide</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content>
                     <br/>
                     <content styleCode="bold">KEEP TIGHTLY SEALED WHEN NOT IN USE</content>
                  </paragraph>
                  <paragraph>Restricted Drug (California) - Use only as directed. Not for human use.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents: 1 Gallon (128 fl. oz.)</content>
                  </paragraph>
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                  <paragraph>Manufactured for:<br/>Huvepharma, Inc.<br/>525 Westpark Drive, Suite 230<br/>Peachtree City, GA 30269</paragraph>
                  <paragraph>
                     <content styleCode="bold">HUVEPHARMA®</content>
                  </paragraph>
                  <paragraph>HUVEPHARMA and Sul-Q-Nox are registered<br/>trademarks of Huvepharma EOOD</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L80f20974-bf4c-41bd-80df-4cc8f1159fd0"/>
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                  <paragraph>Approved by FDA under NADA # 006-891<br/>P08-4001SL<br/>Rev. 01-2022</paragraph>
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                     <content styleCode="bold">CAUTION:</content>
                  </paragraph>
                  <paragraph>• May cause toxic reactions unless drug is evenly mixed in water at dosages indicated and used according<br/>to directions.<br/>• Levels of sulfaquinoxaline higher than 0.025% in feed or 0.012% in water for more than 24 to 36 hours<br/>may result in reduced growth rate in chickens as a result of reduced feed or water intake.<br/>• For control of disease outbreaks, medication should be initiated as soon as diagnosis is determined.<br/>• Treated animals must actually consume enough medicated water to provide a necessary dosage of<br/>approximately 10 to 45 mg/lb/day in chickens and 3.5 to 55 mg/lb/day in turkeys and 6 mg/lb/day in<br/>cattle and calves, depending on class of animal, ambient temperature, age, and other factors.<br/>• Prolonged administration of sulfaquinoxaline at higher doses may result in depressed feed or water<br/>intake, deposition of sulfaquinoxaline crystals in kidney and interference with normal blood clotting.<br/>• Do not mix or administer in galvanized containers.<br/>• The follwing word is required on this product to comply with Agricultural Code of California:<br/>HAZARDOUS<br/>• CAUSES SKIN AND EYE BURNS. Avoid contact with eyes, skin, or clothing. In case of contact, flush<br/>immediately with water for at least 15 minutes; for eye get medical attention.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING:</content>
                  </paragraph>
                  <paragraph>• Withdraw use of product 10 days before slaughter.<br/>• A withdrawal period has not been established for this product in pre-ruminating<br/>calves. Do not use in calves to be processed for veal.<br/>• Do not medicate chickens or turkeys producing eggs for human<br/>consumption.<br/>• Not for use in lactating dairy cattle.<br/>• DISPOSE OF ANY WASTE OR UNUSED PORTION PROPERLY.<br/>• KEEP ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.<br/>• Store between 20°- 25°C (68°- 77°F); excursions permitted between<br/>15°- 40°C (59°- 104°F).</paragraph>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR AUTOMATIC DRINKING WATER PROPORTIONERS</content>
                     <br/>FOR CONTROL OR TREATMENT OF THE FOLLOWING DISEASES WHEN CAUSED BY ONE<br/>OR MORE PATHOGENIC ORGANISMS SUSCEPTIBLE TO SULFAQUINOXALINE<br/>
                     <content styleCode="bold">PREPARE MEDICATED DRINKING WATER FRESH DAILY</content>
                  </paragraph>
                  <table width="100%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold">               INDICATIONS</content>
                           </td>
                           <td>
                              <content styleCode="bold">DOSAGE PER 128 GALLONS OF</content>
                              <br/>
                              <content styleCode="bold">WATER</content>
                           </td>
                           <td>
                              <content styleCode="bold">                                 TREATMENT</content>
                           </td>
                        </tr>
                        <tr>
                           <td rowspan="2">
                              <content styleCode="bold">COCCIDIOSIS — CHICKENS:</content>
                              <br/>Control of coccidiosis caused by <content styleCode="italics">Eimeria tenella,</content>
                              <br/>
                              <content styleCode="italics">E. necatrix, E. maxima, E. brunetti, E. acervulina</content>,<br/>susceptible to sulfaquinoxaline. </td>
                           <td>
                              <content styleCode="bold">20½ fl. oz.</content>
                              <br/>
                              <content styleCode="bold">(0.04%)</content>
                           </td>
                           <td>
                              <paragraph>            Give for 2-3 days, skip 3 days.</paragraph>
                              <paragraph>
                                 <content styleCode="bold">                                          Then</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">13 fl. oz.</content>
                              <br/>
                              <content styleCode="bold">(0.025%)</content>
                           </td>
                           <td>Give for 2 days more. If bloody droppings appear, repeat<br/>treatment at this level for 2 more days.<br/>
                              <content styleCode="bold">CAUTION:</content> Do not change litter unless absolutely<br/>necessary. Do not give flushing mashes.</td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">COCCIDIOSIS — TURKEYS:</content>
                              <br/>Control of coccidiosis caused by <content styleCode="italics">Eimeria</content>
                              <br/>
                              <content styleCode="italics">meleagrimitis, E. adenoeides</content>, susceptible to<br/>sulfaquinoxaline.</td>
                           <td>
                              <content styleCode="bold">13 fl. oz.</content>
                              <br/>
                              <content styleCode="bold">(0.025%)</content>
                           </td>
                           <td>Give for 2 days - skip 3 days - give for 2 days - skip 3 days<br/>and give 2 more days. Repeat if necessary.<br/>
                              <content styleCode="bold">CAUTION:</content> Do not change litter unless absolutely<br/>necessary. Do not give flushing mashes.</td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">ACUTE FOWL CHOLERA — CHICKENS AND</content>
                              <br/>
                              <content styleCode="bold">TURKEYS:</content>
                              <br/>Control of acute fowl cholera caused by<br/>
                              <content styleCode="italics">Pasteurella multocida</content> susceptible to<br/>sulfaquinoxaline.<br/>
                              <content styleCode="bold">FOWL TYPHOID — CHICKENS AND TURKEYS:</content>
                              <br/>Control of fowl typhoid caused by <content styleCode="italics">Salmonella</content>
                              <br/>
                              <content styleCode="italics">gallinarum</content>, susceptible to sulfaquinoxaline.</td>
                           <td>
                              <content styleCode="bold">20½ fl. oz.</content>
                              <br/>
                              <content styleCode="bold">(0.04%)</content>
                           </td>
                           <td>Use for 2-3 days. Move birds to clean ground. If disease<br/>recurs, repeat treatment. Poultry that have survived fowl<br/>typhoid outbreaks should not be kept for laying house<br/>replacements or breeders unless tests show they are not<br/>carriers.</td>
                        </tr>
                        <tr>
                           <td>
                              <content styleCode="bold">COCCIDIOSIS — CATTLE AND CALVES:</content>
                              <br/>For the control and treatment of coccidiosis<br/>caused by <content styleCode="italics">Eimeria bovis</content>,<content styleCode="italics"> E. zuernii</content>, susceptible<br/>to sulfaquinoxaline.</td>
                           <td>
                              <content styleCode="bold">7¾ fl. oz.</content>
                              <br/>
                              <content styleCode="bold">(0.015%)</content>
                              <br/>
                              <content styleCode="bold">6 mg/lb</content>
                              <br/>
                              <content styleCode="bold">of body wt.</content>
                           </td>
                           <td>
                              <paragraph>Give for 3-5 days. As a generalization, cattle and calves<br/>will consume approx. 1 gal/100 lbs body weight/day. Cattle<br/>or calves not eating or drinking must be treated</paragraph>
                              <paragraph>individually.</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td colspan="3">
                              <content styleCode="bold">To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, </content>
                              <content styleCode="bold">Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, </content>
                              <content styleCode="bold">contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</content>
                           </td>
                        </tr>
                     </tbody>
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