Label: BIOMOX- amoxicillin suspension

  • NDC Code(s): 51311-300-15, 51311-300-30
  • Packager: Virbac AH, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 10, 2017

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

  • SPL UNCLASSIFIED SECTION

    Veterinary For Oral Suspension
    For use in DOGS only.

  • DESCRIPTION

    BIOMOX® (amoxicillin) is 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-(-)a-amino-p-hydroxybenzyl penicillin trihydrate.

  • Inactive Ingredients

    Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sucrose.

  • ACTION

    Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial wall mucopeptides. Most strains of the following gram-positive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta-hemolytic streptococci, Streptococcus 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) for oral suspension is indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:

    BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and E. coli.

    SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp., E. coli, Proteus mirabilis and Staphylococcus spp.

    As is true 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) for oral suspension 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. Continue for 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

  • DIRECTIONS FOR MIXING ORAL SUSPENSION

    Add sufficient water to the bottle as indicated in the table below and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.

    Bottle SizeAmount of Water to
    Add for Reconstitution
    15 mL11 mL
    30 mL21 mL

    Note: When stored at room temperature or in refrigerator, discard unused portion of reconstituted suspension after 14 days.

  • SUPPLY

    Biomox® (amoxicillin) for oral suspension is supplied in bottles containing 0.75 g of amoxicillin activity in bottles of 15 mL or 1.5 g of amoxicillin activity in bottles of 30 mL. After reconstitution with the required amount of water, each mL will contain 50 mg of amoxicillin as the trihydrate.

  • SPL UNCLASSIFIED SECTION

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

    92515

    05/08

    Rev.-02

  • PRINCIPAL DISPLAY PANEL - 15 mL Powder Bottle

    NDC-051311-300-15

    Virbac
    ANIMAL HEALTH

    BIOMOX®
    (amoxicillin)

    VETERINARY FOR ORAL SUSPENSION

    Equivalent to 0.75 g amoxicillin
    When reconstituted, concentration is
    50 mg/mL amoxicillin as the trihydrate

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

    NADA # 65-495, Approved by FDA

    15 mL (when mixed)

    image description
  • PRINCIPAL DISPLAY PANEL - 30 mL Powder Bottle

    NDC-051311-300-30

    Virbac
    ANIMAL HEALTH

    BIOMOX®
    (amoxicillin)

    VETERINARY FOR ORAL SUSPENSION

    Equivalent to 1.5 g amoxicillin
    When reconstituted, concentration is
    50 mg/mL amoxicillin as the trihydrate

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

    NADA # 65-495, Approved by FDA

    30 mL (when mixed)

    image description
  • INGREDIENTS AND APPEARANCE
    BIOMOX 
    amoxicillin suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS0.75 g  in 15 mL
    Product Characteristics
    ColorWHITE (off-white to pinkish) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-300-1515 mL in 1 BOTTLE, DROPPER
    2NDC:51311-300-3030 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA06549505/24/2010
    Labeler - Virbac AH, Inc. (131568396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medispray Laboratories Private Ltd915793457MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Teva Pharmaceutical USA, Inc.611568031api manufacture