Label: GEN-GARD SOLUBLE POWDER- gentamicin sulfate powder, for solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated July 9, 2023

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

  • SPL UNCLASSIFIED SECTION

    NDC 23243-4740-3
    GEN-GARD®
    (gentamicin sulfate)
    Soluble Powder
    Antibacterial

  • GENERAL PRECAUTIONS

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

  • SPL UNCLASSIFIED SECTION

    Contains 120 grams of
    Gentamicin per jar

    Approved by FDA under ANADA # 200-185
    NET WEIGHT:
    360 g (12.7 oz.)

  • INDICATIONS & USAGE

    For use in swine drinking water only.
    INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatment of colibacillosis in weanling
    swine caused by strains of E. coli sensitive to gentamicin, and for the control and treatment of swine dysentery
    associated with Brachyspira hyodysenteriae.

  • DOSAGE & ADMINISTRATION

    DOSE: Colibacillosis - 1 level scoop per 240 gallons of drinking water for 3 consecutive days, 0.5 mg/lb/day.
    For proportioner use, add 1 level scoop to 2 gallons stock solution and dispense at the rate of 1 oz./gal. drinking
    water (25 mg/gal.).
    Swine Dysentery - 1 level scoop per 120 gallons of drinking water for 3 consecutive days, 1.0 mg/lb/day.
    For proportioner use, add 1 level scoop to 1 gallon stock solution and dispense at the rate of 1 oz./gal. drinking
    water (50 mg/gal.).

  • USER SAFETY WARNINGS

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN

    G-7473-03         Rev. 04-2022

  • RESIDUE WARNING

    Each gram contains: gentamicin sulfate equivalent to
    333.33 mg gentamicin base.

    RESIDUE WARNING: Swine treated with the recommended dose of GEN-GARD
    Soluble Powder must not be slaughtered for food for at least ten (10) days following
    the last treatment.

  • STORAGE AND HANDLING

    Do not store or offer medicated water in rusty metal containers.

    Read package insert directions carefully.
    Store between 2º and 30ºC (36º and 86ºF).
    For use in swine drinking water only.
    Restricted drug (California)- 
    Use only as directed.

    ®Registered trademark of Huvepharma, Inc.
    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269

    Lot No.             Exp. Date

  • SPL UNCLASSIFIED SECTION

    GEN-GARD®
    (gentamicin sulfate)
    Soluble Powder
    Antibacterial

  • GENERAL PRECAUTIONS

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

    For Swine Drinking Water Only.

  • RESIDUE WARNING

    DESCRIPTION: Each gram of GEN-GARD Soluble Powder contains gentamicin sulfate
    equivalent to 333.33 mg gentamicin base.

    RESIDUE WARNING: Swine treated with the recommended dose of
    GEN-GARD Soluble Powder must not be slaughtered for food for at least ten
    (10) days following the last treatment.

  • INDICATIONS & USAGE

    INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatment
    of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin
    and for the control and treatment of swine dysentery associated with Brachyspira
    hyodysenteriae.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: GEN-GARD Soluble Powder is available in a 360 gram
    jar. The 360 gram jar contains a scoop that provides approximately 18 grams of product
    when level full.

    For Control and Treatment of Colibacillosis - Administer GEN-GARD Soluble Powder in
    drinking water at the recommended level of 25 mg per gallon (1 scoop/240 gallons) for
    three consecutive days.

    For Control and Treatment of Swine Dysentery - Administer GEN-GARD Soluble Powder in
    drinking water at the recommended level of 50 mg per gallon (1 scoop/120 gallons) for
    three consecutive days.

    The concentration of the medication should be adjusted in extremely hot or cold
    weather to ensure a gentamicin dosage of approximately 0.5 mg/lb/day for 3 days for
    colibacillosis or 1.0 mg/lb/day for 3 days for swine dysentery. A 50-lb pig will, under
    average conditions, consume 0.9 gallon of water per day.

    For swine dysentery, if the condition recurs, the medication may be repeated. Because
    of the tendency for the disease to recur on a premise with a history of swine dysentery,
    a control program should be used following treatment.

  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR USE: To prepare medicated water, mix GEN-GARD Soluble Powder and
    drinking water according to the following tables:

    Proportioner Use:
    For Control and Treatment of Colibacillosis
       Add 18 g (1 scoop) GEN-GARD to 2 gallons of water to make stock solution and
       dispense at the rate of one ounce per gallon of drinking water. This will result in
       drinking water that contains 25 mg/gallon.

    For Control and Treatment of Swine Dysentery
       Add 18 g (1 scoop) GEN-GARD to 1 gallon of water to make stock solution and
       dispense at the rate of one ounce per gallon of drinking water. This will result in
       drinking water that contains 50 mg/gallon.

    Bulk Preparation:
    For Control and Treatment of Colibacillosis
       Add 18 g (1 scoop) GEN-GARD to 240 gallons of water.

    For Control and Treatment of Swine Dysentery
       Add 18 g (1 scoop) GEN-GARD to 120 gallons of water.

    Medicated drinking water should not be stored or offered in rusty containers since the
    drug is quickly destroyed in such containers.

    Medicated water should be prepared daily and be the sole source of drinking water for
    3 consecutive days.

    The daily water consumption figures shown below are approximations for mild
    temperatures and are presented as a guide only. Actual water consumption varies with
    environmental temperature, humidity, and diet.

    Water Table

  • ADVERSE REACTIONS

    SIDE EFFECTS: There have been no reported side effects following the recommended use
    of GEN-GARD Soluble Powder in swine.

    To report suspected adverse drug events, for technical assistance or to obtain
    a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse drug experience reporting
    for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: There are no known contraindications to this drug when used
    as directed.

  • STORAGE AND HANDLING

    STORAGE CONDITIONS: Store between 2° and 30°C (36° and 86°F)

  • SPL UNCLASSIFIED SECTION

    HOW SUPPLIED: GEN-GARD Soluble Powder is available in a 360 gram jar with 2 jars
    per shipper.

    Approved by FDA under ANADA # 200-185
    Not for Use in Humans
    Keep Out of Reach of Children
    Restricted Drug (California) –
    use only as directed

    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269         Rev. 04-2022

  • PRINCIPAL DISPLAY PANEL

    GenGard Jar

    Insert_Page 1

    Insert_Page 2

  • INGREDIENTS AND APPEARANCE
    GEN-GARD  SOLUBLE POWDER
    gentamicin sulfate powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-4740
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN333.33 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-4740-3360 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20018504/04/2011
    Labeler - Huvepharma, Inc (619153559)
    Registrant - Huvepharma EOOD (552671651)