Label: AMOXI-TABS- amoxicillin tablet, film coated

  • NDC Code(s): 54771-6042-2, 54771-6043-3
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 24, 2021

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  • SPL UNCLASSIFIED SECTION

    For use in dogs and cats

  • CAUTION

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

  • DESCRIPTION

    Amoxi-Tabs (amoxicillin tablets) 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(-)-a-amino-p-hydroxybenzyl penicillin trihydrate.

  • 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: a- and b-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

  • 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.

  • CONTRAINDICATIONS

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

  • WARNING

    For use in dogs and cats only

  • 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

  • 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.

  • STORAGE AND HANDLING

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

    Keep Bottle Tightly Closed.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 055-078
    Approved by FDA under NADA # 055-081

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    P1523357
    Revised: January 2020

  • PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

    50 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

    100 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    AMOXI-TABS 
    amoxicillin tablet, film coated
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-6042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    (2S,5R,6R)-6-((R)-(-)-2-AMINO-2-(P-HYDROXYPHENYL)ACETAMIDO)-3,3-DIMETHYL-7-OXO-4-THIA-1-AZABICYCL(3.2.0)HEPTANE-2-CARBOXYLIC ACID TRIHYDRATE (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS50 mg
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code BMP193
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-6042-2500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA05508106/02/1978
    AMOXI-TABS 
    amoxicillin tablet, film coated
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-6043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    (2S,5R,6R)-6-((R)-(-)-2-AMINO-2-(P-HYDROXYPHENYL)ACETAMIDO)-3,3-DIMETHYL-7-OXO-4-THIA-1-AZABICYCL(3.2.0)HEPTANE-2-CARBOXYLIC ACID TRIHYDRATE (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS100 mg
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code BMP202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-6043-3500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA05508106/02/1978
    Labeler - Zoetis Inc. (828851555)