Label: TETRAMED 324 HCA - tetracycline hydrochloride powder

  • NDC Code(s): 61133-5803-1, 61133-5803-2, 61133-5803-3, 61133-5803-4, view more
    61133-5803-5
  • Packager: Bimeda, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated December 5, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    TetraMed® 324 HCA

    (tetracycline hydrochloride)

    Soluble Powder

    FOR ORAL USE IN SWINE, CALVES, CHICKENS, AND TURKEYS

    Antibiotic

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

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN

    Restricted Drug (California) - Use Only as Directed

    ANADA 200-374, Approved by FDA

    Each pound contains 324 g of tetracycline hydrochloride.

    Close
  • INDICATIONS & USAGE

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

    FOR SWINE AND CALVES

    INDICATIONS: Use for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli; bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride.

    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.

    Close
  • 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.

    CAUTION:  Do not use for more than 5 consecutive days.

    DIRECTIONS FOR USE:  Administer for 3-5 days.

    Close
  • INDICATIONS & USAGE

    FOR CHICKENS

    INDICATIONS:  Use for the 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.


    FOR TURKEYS

    INDICATIONS:  Use for the control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms sensitive to tetracycline hydrochloride.

    RECOMMENDED DOSAGE LEVEL:  Infectious synovitis: Use soluble powder in the drinking water at a drug level of 400 mg tetracycline hydrochloride per gallon. Bluecomb: Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 25 mg/lb of body weight per day in divided doses.

    Close
  • RESIDUE WARNING

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

    CAUTION:  Not for use in turkeys and 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 a problem.

    Close
  • GENERAL PRECAUTIONS

    GENERAL CAUTION:  When used in plastic or stainless steel waterers prepare fresh solution every 24 hours.  When used in galvanized waterers or automatic medicators, prepare fresh solution every 12 hours.  Prepare fresh stock solution every 12 hours.  Use as 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.

    Close
  • DOSAGE & ADMINISTRATION

    MIXING DIRECTIONS

    FOR SWINE, CALVES AND TURKEYS:  2.52 oz. (two scoops) dissolved in 500 mL (approximately 17 fl. oz.) of warm water will provide a stock solution of 100 mg of tetracycline hydrochloride activity per mL.

    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 two scoops are sufficient to deliver the recommended daily dosage levels as follows:

    At 25 mg/lb of body weight................2,040 total lbs. of turkeys to be medicated.

    At 10 mg/lb of body weight................5,100 total lbs. of swine or calves to be medicated.

    Individual calf treatment....................5 mL (1 measuring teaspoonful) twice daily for each 100 lbs. of body weight administered as a drench or by dose syringe.


    FOR CHICKENS AND TURKEYS:  To arrive at the recommended dosages, use the contents of 2 scoops to prepare stock solutions as follows:

    200 mg/gallon - dissolve 2 scoops (2.52 oz.) in 7,570 mL warm water (2 gallons)

    400 mg/gallon - dissolve 2 scoops (2.52 oz.) in 3,785 mL warm water (1 gallon)

    800 mg/gallon - dissolve 2 scoops (2.52 oz.) in 1,892 mL warm water (0.5 gallon)

    These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon.

    At 200-800 mg/gallon two scoops will provide 63.8 to 255 gallons of 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.

    Close
  • STORAGE AND HANDLING

    Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

    Close
  • INGREDIENTS AND APPEARANCE
    TETRAMED 324 HCA 
    tetracycline hydrochloride powder
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-5803
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    tetracycline hydrochloride (UNII: P6R62377KV) (tetracycline - UNII:F8VB5M810T) tetracycline hydrochloride 1620 g  in 2.27 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-5803-4 2.27 kg in 1 PAIL
    2 NDC:61133-5803-5 11.34 kg in 1 PAIL
    3 NDC:61133-5803-1 .1417 kg in 1 POUCH
    4 NDC:61133-5803-2 .9072 kg in 1 POUCH
    5 NDC:61133-5803-3 1.134 kg in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200374 05/13/2009
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    Name Address ID/FEI Business Operations
    Bimeda, Inc. 060492923 manufacture
    Close