TETRA-BAC 324- tetracycline hydrochloride powder, for solution

Tetra-Bac by

Drug Labeling and Warnings

Tetra-Bac by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

NDC: 23243-3000-9

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

NET WEIGHT:
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

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.

PRECAUTIONS

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

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

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

PRECAUTIONS

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 PRECAUTIONS

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

Manufactured for

Huvepharma, Inc.                                                          Made in Bulgaria
525 Westpark Dr., Suite 230
Peachtree City, GA 30269      ® Registered trademark of Huvepharma, Inc.

DOSAGE & ADMINISTRATION

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 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 1-877-994-4883 or
www.huvepharma.us. For additional information about adverse drug experience
reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.

STORAGE AND HANDLING

Store between 59-77ºF (15-25ºC)

LB6262v2TetraB-324wsp2.27-USA062024

SPL UNCLASSIFIED SECTION

LOT NO.:       EXP. DATE:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TETRA-BAC  324
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)