Tetrasol

Manufacturer
Med-Pharmex, Inc
Effective date
2024-02-21
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:10:58

Label at a glance#

ProductTetrasol
Active ingredientTETRACYCLINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

DESCRIPTION SECTION

(tetracycline hydrochloride)

Antibiotic

Approved by FDA under ANADA # 200-234

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

FOR USE IN ANIMALS ONLY - - KEEP OUT OF REACH OF CHILDREN

Each pound contains 324 g of tetracycline hydrochloride.
Net Wt.: 5 lbs. (2.27 kg)

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

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

SWINE AND CALVES

INDICATIONS: 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.

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

_________________________

CHICKENS

INDICATIONS: 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.

_________________________

TURKEYS

INDICATIONS: 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.

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 sign of disease or when experience indicates the disease may be a problem.

WARNINGS:

WARNINGS SECTION

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.

____

POULTRY - Do not slaughter birds for food within 4 days of treatment.

GENERAL CAUTION:

GENERAL PRECAUTIONS SECTION

Prepare fresh solutions at least once a day. Solutions are not stable for more than 24 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 AND ADMINISTRATION:

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 of 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 enclosed 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 - Net Weight: 5 lbs. (2.27 kg)

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 lbs) 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.

RESTRICTED DRUG (California) – USE ONLY AS DIRECTED

TAKE TIME OBSERVE LABEL DIRECTIONS

HOW SUPPLIED SECTION

CONTACT INFORMATION:
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae

Manufactured by:
Med-Pharmex, Inc.
Pomona, CA 91767

Rev. Feb. 2024

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MPX Tetrasol - 5 lbs - LabelMPX Tetrasol - 5 lbs - Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54925-033TETRASOL (TETRACYCLINE HYDROCHLORIDE) POWDER, FOR SOLUTION [MED-PHARMEX, INC]5Unmatched20240224_65ba2f62-ddb1-48d4-84bf-e824957969af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KV1
TETRACYCLINEACTIVE MOIETYF8VB5M810T1

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
54925-03354925-033-50

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.