TetraMed 324 HCA - Bimeda, Inc.

Manufacturer
Bimeda, Inc.
Effective date
2024-10-07
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:43:34

Label at a glance#

ProductTetraMed 324 HCA
Active ingredienttetracycline hydrochloride
Label structure10 sections

Storage and handling

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 by: Bimeda, Inc. Le Sueur, MN 56058 www.bimeda.com

Label contents#

Full prescribing information#

DESCRIPTION SECTION

TetraMed® 324 HCA
(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.)

INDICATIONS & USAGE SECTION

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 SECTION

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.

INDICATIONS & USAGE SECTION

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 SECTION

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.

GENERAL PRECAUTIONS SECTION

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

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

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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

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 by:
Bimeda, Inc.
Le Sueur, MN 56058
www.bimeda.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TETRACYCLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61133-5803-1TetraMed 324 HCA.1417 kg in 1 POUCHPOWDER.141712
61133-5803-2TetraMed 324 HCA.9072 kg in 1 POUCHPOWDER.907212
61133-5803-3TetraMed 324 HCA1.134 kg in 1 POUCHPOWDER1.13412
61133-5803-4TetraMed 324 HCA2.27 kg in 1 PAILPOWDER2.2712
61133-5803-5TetraMed 324 HCA11.34 kg in 1 PAILPOWDER11.3412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-5803TETRAMED 324 HCA (TETRACYCLINE HYDROCHLORIDE) POWDER [BIMEDA, INC.]125 package rows20241009_bc723e31-99f6-40cb-94ab-1b64d359fa0d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
tetracycline hydrochlorideACTIVE INGREDIENTP6R62377KV3
tetracyclineACTIVE MOIETYF8VB5M810T3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61133-580361133-5803-4, 61133-5803-5, 61133-5803-1, 61133-5803-2, 61133-5803-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
tetracycline hydrochlorideP6R62377KVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack02e88b4a-57ae-4ef6-ba48-97c657202b942026-08-11Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc. .ccd30048-a226-455f-971b-5dbf14b22e9d2026-06-11Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.00acf413-c5d2-4a54-9d0d-56266cbc9edc2026-05-22Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack22208459-3e6f-46a7-9f7f-f2c254a381322026-05-12Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEProficient Rx LPd48071a0-c397-42f8-b8ad-158282e745e32026-05-01Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCb504e612-5aef-47fa-8f7b-dfb754011b9f2026-04-14Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3ce3e8dc-7fbd-4f8d-a65f-092e1ef217252025-11-06Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCae29aa18-6efb-47c9-bbd7-cbe8af1b7f382025-04-24Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEActavis Pharma, Inc.32a409a0-fea6-411a-8218-c1c7df46d6642025-04-09Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4202cbfb-52e9-47f2-bd3a-1003319ca3cb2025-03-24Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.eaa5b1bd-0927-46e4-b941-32fcc492d2582025-03-18Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack58e4b5b3-e093-46e7-b28e-a2c4821c5b632024-11-12Warnings, Adverse reactionsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.