Label: BIOMOX- amoxicillin tablet

  • NDC Code(s): 51311-201-50, 51311-203-50, 51311-205-50
  • Packager: Virbac AH, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated January 5, 2022

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  • SPL UNCLASSIFIED SECTION

    For use in DOGS only.

  • DESCRIPTION

    BIOMOX® (amoxicillin tablets) are a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.

  • Inactive Ingredients

    Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

  • ACTION

    Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial cell wall mucopeptides. Most strains of the following grampositive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta- hemolytic streptococci, Enterococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Enterobacter and Klebsiella and all strains of Pseudomonas are resistant. Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.

  • INDICATIONS

    BIOMOX® (amoxicillin tablets) are indicated for treatment of the following infections in dogs when caused by susceptible strains of organisms:

    BACTERIAL DERMATITIS due to Staphylococcus aureus, Strepto-coccus spp., Staphylococcus spp., and Escherichia coli.

    SOFT TISSUE INFECTIONS
    (abscesses, wounds, lacerations) due to Staphylococcus aureus,Enterococcus faecalis, Escherichia coli, Proteus mirabilis, and Staphylococcus spp.

    With all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

  • CONTRAINDICATIONS

    Use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.

  • ADVERSE REACTIONS

    Amoxicillin is a semisynthetic penicillin and, therefore, has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.

  • WARNINGS

    For use in dogs only.

  • PRECAUTIONS

    Until adequate reproductive studies are accomplished, Biomox® (amoxicillin tablets) should not be used in pregnant or breeding animals.

  • CAUTION

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

  • DOSAGE AND ADMINISTRATION

    The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

  • SUPPLY

    Biomox® (amoxicillin tablets) are supplied in 50 mg, 100 mg and 200 mg concentrations in bottles of 500 tablets.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Virbac AH, Inc.
    P.O. Box 162059
    Fort Worth, TX 76161
    1-800-338-3659

    Printed in USA Rev. -06 05/19

    ©2019 Virbac Corporation. All Rights Reserved.BIOMOX is a registered trademark of Virbac AH, Inc.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BIOMOX 
    amoxicillin tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS50 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-201-50500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA06549205/24/2010
    BIOMOX 
    amoxicillin tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS100 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-203-50500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA06549205/24/2010
    BIOMOX 
    amoxicillin tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS200 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-205-50500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA06549205/24/2010
    Labeler - Virbac AH, Inc. (131568396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medispray Laboratories Private Ltd915793457manufacture
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    NameAddressID/FEIBusiness Operations
    Centrient Pharmaceuticals Netherlands860184986api manufacture
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    Alcami Missouri Corporation117877975analysis
    Establishment
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    Alcami Carolinas Corporation831351445analysis