MedPath

Tetracycline

Approved
Approval ID

80c8372b-c43e-4803-889c-c9deac815339

Product Type

PRESCRIPTION ANIMAL DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Aspen Veterinary Resources

DUNS: 627265361

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tetracycline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46066-256
Application NumberANADA200374
Product Classification
M
Marketing Category
C73583
G
Generic Name
Tetracycline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (1)

TETRACYCLINEActive
Quantity: 324 g in 2.27 kg
Code: F8VB5M810T
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/6/2025

INDICATIONS: For use in the control and treatment of the following conditions in swine, calves and poultry.

FOR SWINE AND CALVES
INDICATIONS: Use for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli; bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride.
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.
CAUTION: Do not use for more than 5 consecutive days.
DIRECTIONS FOR USE: Administer for 3-5 days.

FOR CHICKENS
INDICATIONS: Use for the 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.

FOR TURKEYS
INDICATIONS: Use for the control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms sensitive to tetracycline hydrochloride.
RECOMMENDED DOSAGE LEVEL: Infectious synovitis: Use soluble powder in the drinking water at a drug level of 400 mg tetracycline hydrochloride per gallon. Bluecomb: Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 25 mg/lb of body weight per day in divided doses.
RESIDUE WARNING: Do not slaughter birds for food within 4 days of treatment.
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 dictates the disease may be a problem.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 8/20/2025

Tetracycline SP 324 Powder
(tetracycline hydrochloride)
Soluble Powder

FOR ORAL USE IN SWINE, CALVES, CHICKENS, AND TURKEYS

Antibiotic

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN

Approved by FDA under ANADA # 200-374

Each pound contains 324 g of tetracycline hydrochloride.

Net Weight: 2.27 kg (5 lb.)

GENERAL PRECAUTIONS SECTION

LOINC: 34072-9Updated: 3/6/2025

GENERAL CAUTION: When used in plastic or stainless steel waterers prepare fresh solution every 24 hours. When used in galvanized waterers or automatic medicators, prepare fresh solution every 12 hours. Prepare fresh stock solution every 12 hours. Use as 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/6/2025

MIXING DIRECTIONS:
FOR SWINE, CALVES, AND TURKEYS: 2.52 oz. (two scoops) dissolved in 500 mL (approximately 17 fl. oz.) of warm water will provide a stock solution of 100 mg of tetracycline hydrochloride activity per mL.
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 two scoops are sufficient to deliver the recommended daily dosage levels as follows:
At 25 mg/lb of body weight 2,040 total lbs. of turkeys to be medicated.
At 10 mg/lb body weight 5,100 total lbs. of swine or calves to be medicated.
Individual calf treatment 5 mL (1 measuring teaspoonful) twice daily for each 100 lbs. of body weight administered as a drench or by dose syringe.

FOR CHICKENS AND TURKEYS: To arrive at the recommended dosages, use the contents of 2 scoops to prepare stock solutions as follows:
200 mg/gallon – dissolve 2 scoops (2.52 oz.) in 7,570 mL warm water (2 gallons)
400 mg/gallon – dissolve 2 scoops (2.52 oz.) in 3,785 mL warm water (1 gallon)
800 mg/gallon – dissolve 2 scoops (2.52 oz.) in 1,892 mL warm water (0.5 gallon)
These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon.
At 200-800 mg/gallon two scoops will provide 63.8 to 255 gallons of 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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/6/2025

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aspen Veterinary Resources at info@aspenveterinaryresources.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/6/2025

Store at controlled room temperature 20°C – 25°C (68°F-77°F), with excursions permitted to 15°C-30°C (59°F-86°F).

Manufactured for:
Aspen Veterinary Resources®, LTD.
Liberty, MO 64068, USA
www.aspenveterinaryresources.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.