Tetra-Bac

Manufacturer
Agri Laboratories, Ltd.
Effective date
2017-05-04
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-02 01:16:37

Label at a glance#

ProductTetra-Bac 324
Active ingredientTETRACYCLINE HYDROCHLORIDE
Label structure6 sections

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 : ...

Storage and handling

Store at 59°-86°F

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION


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

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 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. 

RESIDUE WARNING

RESIDUE WARNING 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.

CAUTION

PRECAUTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

Store at 59°-86°F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AL-Tetracycline PowderAL-Tetracycline Powder

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KV5
TETRACYCLINEACTIVE MOIETYF8VB5M810T5

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
57561-30057561-300-09, 57561-300-70

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.