Label: TETRA-BAC 324- tetracycline hydrochloride powder, for solution
- NDC Code(s): 23243-3000-9
- Packager: Huvepharma, Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated February 19, 2021
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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
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: 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.
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
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
DOSAGE & ADMINISTRATION
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
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INGREDIENTS AND APPEARANCE
tetracycline hydrochloride powder, for solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:23243-3000 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE 324 g in 453.6 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-3000-9 2268.0 g in 1 PAIL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200049 02/19/2021 Labeler - Huvepharma, Inc (619153559)