Label: TET-SOL 324- tetracycline hydrochloride powder, for solution 

  • NDC Code(s): 46573-217-10, 46573-217-26
  • Packager: Alpharma Inc. Animal Health
  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/09

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  • INDICATIONS — CHICKENS

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

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  • RECOMMENDED DOSAGE LEVEL

    Administer for 7-14 days.

    CRD air sac disease

    Use soluble powder in the drinking water at a drug level of 400-800 mg tetracycline hydrochloride per gallon per day

    Infectious synovitis

    Use soluble powder in the drinking water at a drug level of 200-400 mg tetracycline hydrochloride per gallon per day

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  • INDICATIONS — TURKEYS

    Control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, corona viral enteritis) complicated by organisms susceptible to tetracycline hydrochloride.

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  • RECOMMENDED DOSAGE LEVEL

    Administer for 7-14 days.

    Infectious synovitis

    Use soluble powder in the drinking water at a drug level of 400 mg tetracycline hydrochloride per gallon per day

    Bluecomb

    Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 25 mg/pound of body weight per day in divided doses.

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  • INDICATIONS — SWINE AND CALVES

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

    RECOMMENDED DOSAGE LEVEL

    Administer for 3-5 days.

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

    SPECIAL DIRECTIONS FOR BABY CALVES AND BABY PIGS

    Administer this product 1 hour before or 2 hours after feeding milk or milk replacers. Provide clean (unmedicated) drinking water at all times.

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  • WARNING

    Do not slaughter birds or swine for food within 4 days of treatment or calves 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. Not for use in turkeys or chickens producing eggs for human consumption.

    Do not use for more than 5 consecutive days in swine and calves, or 14 consecutive days in birds.

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  • DIRECTIONS FOR USE

    Prepare fresh solutions at least once a day. Solutions are not stable for more than 24 hours. Use as a sole source of tetracycline. Deliver the recommended dosage level in divided doses. Medicate at first clinical signs of disease or when experience indicates the disease may be a problem. 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.

    MIXING DIRECTIONS FOR TURKEYS, SWINE AND CATTLE

    40 oz dissolved in 8000 ml (approximately 2.1 gallons) of warm water will provide a stock solution of 100 mg of tetracycline hydrochloride activity per ml. This stock solution, when metered at approximately 1 ounce/gallon, will provide drinking water containing 2957 mg of tetracycline hydrochloride activity per gallon for turkeys. The contents of this packet are sufficient to deliver the recommended daily dosage levels as follows:

    At 25 mg/pound of body weight – 32,400 total pounds of turkeys to be medicated in divided doses.

    At 10 mg/pound of body weight – 81,000 total pounds of calves or swine to be medicated in divided doses.

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

    MIXING DIRECTIONS FOR CHICKENS AND TURKEYS

    To arrive at the recommended dosages, prepare stock solutions as follows:

    200 mg/gallon – dissolve 1 packet (40 oz) in 121,120 ml warm water (32 gallons)

    400 mg/gallon – dissolve 1 packet (40 oz) in 60,560 ml warm water (16 gallons)

    800 mg/gallon – dissolve 1 packet (40 oz) in 30,280 ml warm water (8 gallons)

    These stock solutions should then be metered into drinking water at approximately 1 ounce per gallon. At 200-800 mg/gallon this packet will medicate 1012 to 4050 gallons of drinking water.

    NOTE

    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.

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  • HOW SUPPLIED

    Each pound contains 324 g of tetracycline hydrochloride activity.

    This package contains 810 g of tetracycline hydrochloride activity.

    Store below 77°F (25°C.)

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  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Restricted Drug (California) - Use only as directed.

    Net Weight 40 oz (1134 Grams)

    Take Time Observe Label Directions

    Alpharma Inc.
    Bridgewater, NJ 08807

    33924BF 0903
    NADA #65-140, Approved by FDA
    Trademarks registered by Alpharma Inc.

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  • PRINCIPAL DISPLAY PANEL - 1134 Gram Label

    RUSSELL®

    Tetracycline
    Hydrochloride

    Soluble Powder

    Antibiotic

    Tet-Sol®
    324

    For use in drinking water

    For swine, calves, and poultry

    Each pound contains 324 g of
    tetracycline hydrochloride activity.

    This package contains 810 g of
    tetracycline hydrochloride activity.

    Store below 77° F (25° C)

    For Animal Use Only

    Restricted Drug (California) -
    Use only as directed.

    Net Weight
    40 oz (1134 Grams)

    Take Time
    Observe Label
    Directions

    Alpharma Inc.
    Bridgewater, New Jersey 08807

    33924BF 0903
    NADA #65-140, Approved by FDA
    Trademarks registered by Alpharma Inc.

    Principal Display Panel - 1134 Gram Label
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  • PRINCIPAL DISPLAY PANEL - 10 pack Label

    RUSSELL®

    Tetracycline
    Hydrochloride
    Soluble Powder

    Antibiotic

    Tet-Sol®
    324

    Follow directions for use and mixing instructions on packet label.

    CAUTION: Not for human use / for oral use in animals only

    Store below 77°F (25°C.)

    Lot:

    Exp.:

    Contents: 10 packs, 40 oz (1134 grams) each

    Take Time
    Observe Label
    Directions

    List # 33924
    33924CL 0912
    Restricted Drug (California) - Use
    only as directed.
    NADA #65-140, Approved by FDA

    Trademarks registered by Alpharma Inc.

    Alpharma Inc.
    Bridgewater, New Jersey 08807

    Principal Display Panel - 10 pack Label
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  • INGREDIENTS AND APPEARANCE
    TET-SOL 324 
    tetracycline hydrochloride powder, for solution
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:46573-217
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tetracycline Hydrochloride (Tetracycline) Tetracycline Hydrochloride 324 g  in 0.45 kg
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46573-217-10 10 in 1 CONTAINER
    1 NDC:46573-217-26 1.134 kg in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA065140 01/01/2009
    Labeler - Alpharma Inc. Animal Health (070954094)
    Establishment
    Name Address ID/FEI Business Operations
    Alpharma Inc. Animal Health 090610770 MANUFACTURE, ANALYSIS, RELABEL, REPACK
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