Tetra-Bac

Manufacturer
Huvepharma, Inc
Effective date
2025-03-17
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:44:27

Label at a glance#

ProductTetra-Bac 324
Active ingredientTETRACYCLINE HYDROCHLORIDE
Label structure15 sections

Storage and handling

Store between 59-77ºF (15-25ºC) LB6262v2TetraB-324wsp2.27-USA062024

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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 SECTION

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 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.

PRECAUTIONS SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

PRECAUTIONS SECTION

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 SECTION

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 SECTION

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
www.fda.gov/reportanimalae.

STORAGE AND HANDLING SECTION

Store between 59-77ºF (15-25ºC)

LB6262v2TetraB-324wsp2.27-USA062024

SPL UNCLASSIFIED SECTION

Take Time ImageTake Time Image

LOT NO.:       EXP. DATE:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HVP TetraBac V11HVP TetraBac V11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TetraBac 06-024TetraBac 06-024

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
23243-3000-9Tetra-Bac3242268.0 g in 1 PAILPOWDER, FOR SOLUTION2268.04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-3000TETRA-BAC 324 (TETRACYCLINE HYDROCHLORIDE) POWDER, FOR SOLUTION [HUVEPHARMA, INC]41 package rows20250319_1fad526a-6b75-445a-8bda-a89727709651.zip

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
23243-300023243-3000-9

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.