Label: AMOXI-TABS- amoxicillin tablet, film coated 

  • Label RSS
  • NDC Code(s): 61106-6044-4, 61106-6046-6, 61106-8007-7
  • Packager: Pfizer Animal Health
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Veterinary Tablets

    For use in dogs and cats

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  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • DESCRIPTION

    Amoxi-Tabs (amoxicillin) 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.

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  • CLINICAL PHARMACOLOGY

    Amoxi-Tabs 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.

    Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms. It acts through the inhibition of biosynthesis of cell wall mucopeptide. In vitro and/or in vivo 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, Streptococcus faecalis, Escherichia coli, and Proteus mirabilis. 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.

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  • INDICATIONS AND USAGE

    Dogs

    Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:

    Respiratory tract infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

    Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

    Gastrointestinal tract infections (bacterial gastroenteritis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

    Bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., and Proteus mirabilis.

    Soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

    Cats

    Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:

    Upper respiratory tract infections due to Staphylococcus aureus, Streptococcus spp., and E. coli.

    Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

    Gastrointestinal tract infections due to E. coli.

    Skin and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Pasteurella multocida.

    As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted.

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  • CONTRAINDICATIONS

    The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

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  • WARNING

    For use in dogs and cats only.

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  • ADVERSE REACTIONS

    Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

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  • DOSAGE AND ADMINISTRATION

    Dogs

    The recommended dosage is 5 mg/lb of body weight twice a day.

    Cats

    The recommended dosage is 50 mg (5–10 mg/lb) once a day.

    Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy.

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  • STORAGE AND HANDLING

    Do Not Store at Temperatures Above 25°C (77°F)

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  • HOW SUPPLIED

    Amoxi-Tabs are supplied in 5 strengths: 50 mg, 100 mg, 150 mg, and 200 mg in bottles of 500 tablets; 400 mg in bottles of 250 tablets.

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  • SPL UNCLASSIFIED SECTION

    NADA #55-078 & #55-081, Approved by FDA

    MADE IN INDIA

    Distributed by:
    Pfizer Animal Health
    Div. of Pfizer Inc
    NY, NY 10017

    P1501359
    75-8004-06IN.00
    Jan 2008

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  • PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label

    amoxitabs®
    (amoxicillin)
    Veterinary Tablets

    For use in dogs only

    Each film-coated tablet contains
    amoxicillin trihydrate equivalent
    to 150 mg of amoxicillin.

    Caution: Federal law restricts this
    drug to use by or on the order
    of a licensed veterinarian.

    150 mg

    500 tablets

    NADA #55-078, Approved by FDA

    Pfizer

    PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

    amoxitabs®
    (amoxicillin)
    Veterinary Tablets

    For use in dogs only

    Each film-coated tablet contains
    amoxicillin trihydrate equivalent
    to 200 mg of amoxicillin.

    Caution: Federal law restricts this
    drug to use by or on the order
    of a licensed veterinarian.

    200 mg

    500 tablets

    NADA #55-078, Approved by FDA

    Pfizer

    PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

    amoxitabs®
    (amoxicillin)
    Veterinary Tablets

    For use in dogs only

    Each film-coated tablet contains
    amoxicillin trihydrate equivalent
    to 400 mg of amoxicillin.

    Caution: Federal law restricts this
    drug to use by or on the order
    of a licensed veterinarian.

    400 mg

    250 tablets

    NADA #55-078, Approved by FDA

    Pfizer

    PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    AMOXI-TABS 
    amoxicillin tablet, film coated
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61106-8007
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous 150 mg
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code BMP208
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-8007-7 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA055078 02/04/1976
    AMOXI-TABS 
    amoxicillin tablet, film coated
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61106-6044
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous 200 mg
    Product Characteristics
    Color ORANGE (Coral) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code BMP203
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-6044-4 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA055078 02/04/1976
    AMOXI-TABS 
    amoxicillin tablet, film coated
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61106-6046
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous 400 mg
    Product Characteristics
    Color GREEN Score no score
    Shape ROUND Size 14mm
    Flavor Imprint Code BMP196
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-6046-6 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA055078 02/04/1976
    Labeler - Pfizer Animal Health (039055157)
    Registrant - Pfizer Inc (943955690)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Ltd. 918917683 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Beecham Pharmaceuticals 595132580 API MANUFACTURE
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