Label: TETRA-BAC 324- tetracycline hydrochloride powder, for solution

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

Drug Label Information

Updated February 19, 2021

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

  • Front Panel

    NDC 23243-300-09

    TETRA-BAC® 324

    (tetracycline hydrochloride)
    Soluble Powder
    Antibiotic

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

    Each pound contains 324g of tetracycline hydrochloride.

    FOR USE IN ANIMALS ONLY

    KEEP OUT OF REACH OF CHILDREN

    Restricted Drug (California)-Use Only as Directed

    Approved by FDA under ANADA # 200-049

    NET WEIGHT:
    5 lb (2.27g)

  • INDICATIONS & USAGE

    INDICATIONS: For use in the control and treatment of the following conditions in swine, calves and poultry.

    SWINE AND CALVES: Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., Klebsiella spp. susceptible to tetracycline.


    RECOMMENDED DOSAGE LEVEL: Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 10 mg/lb of body weight per day in divided doses.

  • RESIDUE WARNING

    RESIDUE WARNING: SWINE- Do not slaughter animals for food purposes within 4 days of treatment. CALVES- Do not slaughter animals for food purposes within 5 days of treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

  • PRECAUTIONS

    CAUTION: Do not use for more than 5 consecutive days.
    DIRECTIONS FOR USE: Administer for 3-5 days.

  • INDICATIONS & USAGE

    CHICKENS: Control of chronic respiratory disease (CRD) and air sac disease caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.

    RECOMMENDED DOSAGE LEVEL: CRD and air sac disease: Use soluble powder in the drinking water at a drug level of 400-800 mg tetracycline hydrochloride per gallon. Infectious synovitis: Use soluble powder in the drinking water at a drug level of 200-400 mg tetracycline hydrochloride per gallon.

  • INDICATIONS & USAGE

    TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline hydrochloride.
    RECOMMENDED DOSAGE LEVEL: Infectious synovitis; 400 mg tetracycline hydrochloride per gallon of drinking water. Bluecomb; 25 mg/lb body weight of tetracycline hydrochloride per day in divided doses.

  • RESIDUE WARNING

    RESIDUE WARNING: Do not slaughter birds for food within 4 days of treatment.

  • PRECAUTIONS

    CAUTION: Not for use in turkeys or chickens producing eggs for human consumption. Do not use for more than 14 consecutive days.
    DIRECTIONS FOR USE: Administer for 7-14 days. Medicate at first clinical signs of disease or when experience indicates the disease may be the problem.

  • GENERAL PRECAUTIONS

    GENERAL CAUTION: Prepare fresh solutions at least once a day. Solutions are not stable
    for more than 24 hours. Use as a sole source of tetracycline. Diagnosis should be
    reconsidered if improvement is not noticed within 3 days. The concentration of drug
    required in medicated water must be adequate to compensate for variations in the age
    and class of animals; feed consumption, and environmental temperature and humidity,
    each of which affects water consumption.

  • SPL UNCLASSIFIED SECTION

    Manufactured for

    Huvepharma, Inc.
    525 Westpark Dr., Suite 230
    Peachtree City, GA 30269

    ® Registered trademark of Huvepharma, Inc.

  • DOSAGE & ADMINISTRATION

    MIXING DIRECTIONS:
    FOR SWINE, CALVES AND TURKEYS: Add one level scoop (1.26 oz) to 250 mL (8.5 oz) of
    warm water and dissolve. This will provide stock solution of 100 mg/mL of tetracycline
    hydrochloride. FOR TURKEYS ONLY: This stock solution when metered at approximately
    1 oz per gallon, will provide drinking water containing 2,957 mg of tetracycline
    hydrochloride activity per gallon.

    The contents of the enclosed scoop are sufficient to deliver the recommended
    daily dosage levels as follows:

    At 25 mg/lb of body weight   1,020 total lbs of turkey to be medicated

    At 10 mg/lb of body weight   2,550 total lbs of swine or calves to be medicated

    Individual calf treatment       5 mL (1 measuring teaspoon) twice daily for each 100 lbs

                                              of body weight administered as a drench or by dose syringe

    CHICKENS AND TURKEYS: To arrive at the recommended dosages, prepare stock
    solutions as follows and meter into the drinking water at 1 oz per gallon.

    200 mg/gallon - dissolve 1 level scoop (1.26 oz) in 3,785 mL warm water (1 gallon)-
                            Provides 128 gallons medicated drinking water.
    400 mg/gallon - dissolve 1 level scoop (1.26 oz) in 1,892 mL warm water (0.5 gallon)-
                            Provides 64 gallons medicated drinking water.
    800 mg/gallon - dissolve 1 level scoop (1.26 oz) in 946 mL warm water (0.25 gallon)-
                            Provides 32 gallons medicated drinking water.

    SPECIAL DIRECTIONS FOR BABY CALVES AND BABY PIGS: Administer this product one
    hour before or two hours after feeding milk or milk replacers. Provide clean (unmedicated)
    drinking water at all times. NOTE: When using a watering trough, this product is to be
    administered twice a day in the drinking water of swine, calves and poultry. One-half of the
    recommended daily dosage level of antibiotic is to be consumed during each administration
    period, thus providing the drug in divided doses.


    The contents of this container (5 lb) will provide sufficient drug to treat 162,000 total
    pounds of swine or calves for a single day at the recommended dosage level of 10 mg/lb
    of body weight in divided doses. Or the contents of this container will treat 64,800 lbs of
    turkeys when supplied at 25 mg/lb or at 200-800 mg/gallon will provide 2,025 to 8,100
    gallons of medicated drinking water for chickens or turkeys.


    To report suspected adverse drug events, for technical assistance or to obtain a copy of
    the Safety Data Sheet, contact Huvepharma, Inc., at 1-877-426-7765 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.

  • STORAGE AND HANDLING

    Store between 59-86ºF (15-30ºC)

    T-3897-09
    Rev. 02-2021

  • Take Time

    Take Time Image

    LOT NO.:       EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

    HVP TetraBac V11

  • INGREDIENTS AND APPEARANCE
    TETRA-BAC  324
    tetracycline hydrochloride powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-3000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE324 g  in 453.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-3000-92268.0 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20004902/19/2021
    Labeler - Huvepharma, Inc (619153559)