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   <title>amoxi-drop<sup>®</sup>
      <br/>(amoxicillin)</title>
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            <name>Zoetis Inc.</name>
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                              <name>AMOXICILLIN</name>
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                                 <activeMoiety>
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                                    <name>AMOXICILLIN ANHYDROUS</name>
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                              <numerator unit="mL" value="30"/>
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                              <formCode code="C43171" displayName="BOTTLE, DROPPER" codeSystem="2.16.840.1.113883.3.26.1.1"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title/>
               <text>
                  <paragraph>Amoxi-Drop </paragraph>
                  <paragraph>(amoxicillin for oral suspension), USP<br/>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For veterinary oral suspension</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For use in dogs and cats</content>
                  </paragraph>
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               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>CAUTION</title>
               <text>
                  <paragraph>Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
               </text>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION</title>
               <text>
                  <paragraph>Amoxi-Drop (amoxicillin for oral suspension), USP is a semisynthetic antibiotic with a broad spectrum of activity. It provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.</paragraph>
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               <title>CLINICAL PHARMACOLOGY</title>
               <text>
                  <paragraph>Amoxi-Drop is stable in the presence of gastric acid and may be given without regard to meals. It is rapidly absorbed after oral administration. It diffuses readily into most body tissues and fluids with the exception of brain and spinal fluid, except when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine.</paragraph>
                  <paragraph>Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms. It acts through the inhibition of biosynthesis of cell wall mucopeptide. <content styleCode="italics">In vitro</content> and/or <content styleCode="italics">in vivo</content> studies have demonstrated the susceptibility of most strains of the following gram-positive and gram-negative bacteria: α- and β-haemolytic streptococci, nonpenicillinase-producing staphylococci, <content styleCode="italics">Streptococcus faecalis</content>, <content styleCode="italics">Escherichia coli</content>, and <content styleCode="italics">Proteus mirabilis</content>. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. All strains of Pseudomonas and most strains of Klebsiella and Enterobacter are resistant.</paragraph>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS</title>
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                     <title>Dogs</title>
                     <text>
                        <paragraph>Amoxi-Drop is indicated in the treatment of susceptible strains of the organisms causing the following infections:</paragraph>
                        <paragraph>Respiratory tract infections (tonsillitis, tracheobronchitis) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                        <paragraph>Genitourinary tract infections (cystitis) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                        <paragraph>Gastrointestinal tract infections (bacterial gastroenteritis) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                        <paragraph>Bacterial dermatitis due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                        <paragraph>Soft tissue infections (abscesses, lacerations, and wounds) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                     </text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Cats</title>
                     <text>
                        <paragraph>Amoxi-Drop is indicated in the treatment of susceptible strains of the organisms causing the following infections:</paragraph>
                        <paragraph>Upper respiratory tract infections due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Staphylococcus</content> spp., <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">Haemophilus</content> spp., <content styleCode="italics">E. coli</content>, <content styleCode="italics">Pasteurella</content> spp., and <content styleCode="italics">Proteus mirabilis</content>.</paragraph>
                        <paragraph>Genitourinary tract infections (cystitis) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, <content styleCode="italics">Proteus mirabilis</content>, and <content styleCode="italics">Corynebacterium</content> spp.</paragraph>
                        <paragraph>Gastrointestinal tract infections due to <content styleCode="italics">E. coli</content>, <content styleCode="italics">Proteus</content> spp., <content styleCode="italics">Staphylococcus</content> spp., and <content styleCode="italics">Streptococcus</content> spp.</paragraph>
                        <paragraph>Skin and soft tissue infections (abscesses, lacerations, and wounds) due to <content styleCode="italics">Staphylococcus aureus</content>, <content styleCode="italics">Staphylococcus</content> spp., <content styleCode="italics">Streptococcus</content> spp., <content styleCode="italics">E. coli</content>, and <content styleCode="italics">Pasteurella multocida</content>.</paragraph>
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               <title>CONTRAINDICATIONS</title>
               <text>
                  <paragraph>The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.</paragraph>
               </text>
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               <title>WARNINGS</title>
               <text>
                  <paragraph>For use in dogs and cats only. Not for use in animals which are raised for food production.</paragraph>
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               <title>ADVERSE REACTIONS</title>
               <text>
                  <paragraph>Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.</paragraph>
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               <title>DOSAGE AND ADMINISTRATION</title>
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                     <title>Dogs</title>
                     <text>
                        <paragraph>The recommended dosage is 5 mg/lb of body weight. Administer twice daily for 5–7 days. Continue for 48 hours after all symptoms have subsided.</paragraph>
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                     <title>Cats</title>
                     <text>
                        <paragraph>The recommended dosage is 50 mg (5–10 mg/lb). Administer once daily for 5–7 days. Continue for 48 hours after all symptoms have subsided.</paragraph>
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                     <title>Directions for Mixing Oral Suspension:</title>
                     <text>
                        <paragraph>Add required amount of water (see following table) to the bottle and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.</paragraph>
                        <table>
                           <col/>
                           <col/>
                           <thead>
                              <tr>
                                 <th align="center" valign="bottom"> Bottle Size</th>
                                 <th align="center" valign="bottom"> Amount of Water Required for Reconstitution</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td align="center" valign="bottom"> 15 mL</td>
                                 <td align="center" valign="bottom"> 12 mL</td>
                              </tr>
                              <tr>
                                 <td align="center" valign="bottom"> 30 mL</td>
                                 <td align="center" valign="bottom"> 23 mL</td>
                              </tr>
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                        <paragraph>
                           <content styleCode="bold">Note:</content> Any unused portion of the reconstituted suspension must be discarded after 14 days. After mixing, refrigeration preferable, but not required.</paragraph>
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                     <title/>
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                        <paragraph>
                           <content styleCode="bold">Do Not Store Dry Powder at Temperatures Above 25°C (77°F)</content>
                        </paragraph>
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               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>Amoxi-Drop is supplied in 15-mL bottles containing 0.75 g and 30-mL bottles containing 1.5 g of amoxicillin activity. When reconstituted with required amount of water, each mL contains 50 mg of amoxicillin as the trihydrate.</paragraph>
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               <title/>
               <text>
                  <paragraph>Approved by FDA under NADA # 055-085<br/>
                     <br/>PRODUCT OF SPAIN<br/>
                     <br/>
                     <content styleCode="bold">zoetis</content>
                     <br/>
                     <br/>Distributed by:<br/>Zoetis Inc.<br/>Kalamazoo, MI 49007</paragraph>
                  <paragraph>Revised: February 2019<br/>P1518394</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 15 mL Label</title>
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                     <text>15 mL Label</text>
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