Tetra-Bac 324

(tetracycline hydrochloride) SOLUBLE POWDER

ANTIBIOTIC

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

Tetra-Bac 324 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.

Tetra-Bac 324 Caution

Do not use for more than 5 consecutive days.

Directions For Use

Administer for 3-5 days.

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.

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

Tetra-Bac 324 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 the problem.

GENERAL CAUTION: Use as sole source of tetracycline. When used in 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. Diagnosis should be reconsidered if improvement is not noticed within 3 days.

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.

MIXING DIRECTIONS:

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) of stock solution twice daily for each 100 lbs body weight as a drench or by dose syringe.

The contents of the enclosed scoop are sufficient to deliver the recommended daily dosage levels as follows:

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.

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.

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. The same container will treat 64,800 lb of turkeys when supplied at 25 mg/lb.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

Store between 59-86°F (15-30°C)

Manufactured for Huvepharma, Inc., 525 Westpark Dr., Suite 230, Peachtree City, GA 30269

^® Registered trademark of Huvepharma, Inc.

CPN: 1309074.0