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 January 5, 2022

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-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.

  • Inactive Ingredients

    Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benozate, 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 gramnegative bacteria have demonstrated susceptibility to: amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and betahemolytic 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 improvment 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.

    image description

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

  • SUPPLY

    Bimox® (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 07/19 Rev.-03

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    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
    Centrient Pharmaceuticals Netherlands860184986api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcami Missouri Corporation117877975analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcami Carolinas Corporation831351445analysis