Label: TETRASOL- tetracycline hydrochloride powder, for solution

  • NDC Code(s): 54925-033-02, 54925-033-05, 54925-033-50
  • Packager: Med-Pharmex, Inc
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated July 18, 2017

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  • DESCRIPTION

    Antibiotic

    (Tetracycline Hydrochloride Soluble Powder)

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

    FOR USE IN ANIMALS ONLY

    KEEP OUT OF REACH OF CHILDREN

    Each pound contains 324 g of tetracycline hydrochloride.
    Net Wt.: 2 lbs. (907.2 g)

    Net Wt.: 5 lbs. (2.27 kg)

    Each 5 oz. package contains 101.2 g of tetracycline hydrochloride.
    Net Weight: 5 oz (141.7 g)

    MED-PHARMEX
    INCORPORATED
    POMONA, CA 91767

    ANADA # 200-234 APPROVED BY FDA

  • INDICATIONS & USAGE

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

    SWINE AND CALVES

    INDICATIONS: 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.

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

    CHICKENS

    INDICATIONS: 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.

    TURKEYS

    INDICATIONS: 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.

    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 a problem.

  • WARNINGS

    WARNING:

    SWINE – Do not slaughter animals for food purposes within 4 days if treatment.

    CALVES – Do not slaughter animals for food purposes within 5 days if 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.

    POULTRY - Do not slaughter birds for food within 4 days of treatment.

  • GENERAL PRECAUTIONS

    GENERAL CAUTION:

    Prepare fresh solutions at least once a day. Solution are not stable for more than 24 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.

  • DOSAGE & ADMINISTRATION

    Net Wt.: 2 lbs. (907.2 g)
    Net Wt.: 5 lbs. (2.27 kg)
    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 enclosed 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.

    Net Weight: 5 oz (141.7 g)
    MIXING DIRECTIONS

    FOR SWINE, CALVES AND TURKEYS: 5 oz. dissolved in 1000 mL (approximately 34 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 this package are sufficient to deliver the recommended daily dosage levels as follows:
    At 25 mg/lb of body weight .... 4,048 total lbs of turkeys to be medicated.
    At 10 mg/lb of body weight .... 10,120 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, prepare stock solutions as follows:
    200 mg/gallon - dissolve 1 package (5 oz.) in 15,140 mL warm water (4 gallons)
    400 mg/gallon - dissolve 1 package (5 oz.) in 7,570 mL warm water (2 gallon)
    800 mg/gallon - dissolve 1 package (5 oz.) in 3,785 mL warm water (1 gallon)
    These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon.
    At 200-800 mg/gallon this package will provide 126.5 to 506 gallons of medicated drinking water.


    Net Weight: 5 oz (141.7 g)

    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.

    Net Wt.: 2 lbs. (907.2 g)

    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 (2 lb) will provide sufficient drug to treat 64,800 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 25,920 lbs of turkeys when supplied at 25 mg/lb or at 200-800 mg/gallon will provide 810 to 3,240 gallons of medicated drinking water for chickens or turkeys.

    Net Wt.: 5 lbs. (2.27 kg)

    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.

    RESTRICTED DRUG (California) – USE ONLY AS DIRECTED

    TAKE TIME OBSERVE LABEL DIRECTIONS

    Lot # /Exp. Date:

  • PRINCIPAL DISPLAY PANEL

    Tetrasol Soluble Powder 5lbs. label

    Tetrasol Soluble Powder 2lbs. label

    Tetrasol Soluble Powder 5oz. label

  • INGREDIENTS AND APPEARANCE
    TETRASOL 
    tetracycline hydrochloride powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE714 g  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54925-033-050.1417 kg in 1 POUCH
    2NDC:54925-033-020.9072 kg in 1 CONTAINER
    3NDC:54925-033-502.27 kg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20023407/22/1997
    Labeler - Med-Pharmex, Inc (025353699)