Label: TETRA-BAC 324- tetracycline hydrochloride powder, for solution
- NDC Code(s): 57561-300-09, 57561-300-70
- Packager: Agri Laboratories, Ltd.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated May 4, 2017
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INDICATIONS & USAGE
TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER 324 ANTIBIOTIC
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Each pound contains 324g of tetracycline hydrochloride.
ANADA 200-049, Approved by FDA
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California)-Use Only as Directed
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 byEscherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., Klebsiella spp. susceptible to tetracycline.
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.
RECOMMENDED DOSAGE LEVEL: CRD air sac disease; 400-800 mg tetracycline hydrochloride per gallon of drinking water.
Infectious synovitis; 200-400 mg tetracycline hydrochloride per gallon of drinking water.
TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae, bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline.
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.
- SPL UNCLASSIFIED SECTION
Do not slaughter swine for food purposes within 4 days of treatment. Do not slaughter cattle for food purposes within 5 days of treatment. Do not slaughter poultry for food within 4 days of treatment. Not for use in poultry producing eggs for human consumption. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
Use as sole source of tetracycline. Not to be used in swine or calves for more than 5 days. Not to be used in chickens or turkeys for more than 14 consecutive days. When using plastic or stainless steel waterers or automatic medicators, prepare fresh solution every 24 hours. When used in galvanized waterers, prepare fresh solution every 12 hours. If condition does not improve within 2 to 3 days, consult your veterinarian.
DOSAGE AND ADMINISTRATION
Administer TETRA-BAC 324 in the drinking water of swine and calves for 3 to 5 days at a drug level of tetracycline hydrochloride per gallon to provide approximately 10 mg/lb of body weight, per day in divided doses. In turkeys, for bluecomb only, administer in the drinking water for 7 - 14 days at a drug level of 25 mg/lb of body weight, per day in divided doses.
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 2957 mg of tetracycline hydrochloride activity per gallon.
Calves: Calves may be treated individually by administering 5 mL (1 measuring teaspoonful) to stock solution twice daily for each 100 lbs body weight 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 3785 mL warm water (1 gallon) - Provides 128 gallons medicated drinking water.
400 mg/gallon - dissolve 1 level scoop (1.26 oz) in 1892 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.
NOTE: The concentration of the drug required in medicated water must be adequate to compensate for variation in the age of the animal, feed consumption and the environmental temperature and humidity, each of which affects water consumption.
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. The same container will treat 25,920 lb of turkeys when supplied at 25 mg/lb.
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INGREDIENTS AND APPEARANCE
tetracycline hydrochloride powder, for solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57561-300 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:57561-300-09 2268.0 g in 1 PAIL 2 NDC:57561-300-70 907.2 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200049 06/10/2010 Labeler - Agri Laboratories, Ltd. (155594450)