TETROXY 25- oxytetracycline hcl powder

Tetroxy 25 by

Drug Labeling and Warnings

Tetroxy 25 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Yangzhou Liberty Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Tetroxy® 25

(oxytetracycline HCl)

Soluble Powder

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

A broad spectrum ANTOBIOTIC

FOR CONTROL AND TREATMENT OF SPECIFIC DISEASES

IN POULTRY, CATTLE, SHEEP, SWINE AND HONEY BEES.

This packet contains 10 grams of oxytetracycline hydrochloride

For oral use in poultry, cattle, sheep, swine and honey bees.

FOR USE IN DRINKING WATER ONLY

NOT FOR USE IN LIQUID FEED SUPPLEMENTS

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) - Use Only as Directed

ANADA 200-146, Approved by FDA

INDICATIONS & USAGE

CONTRAINDICATIONS

CONTRAINDICATION: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.

PRECAUTIONS

PRECAUTIONS: Use as sole source of oxytetracycline. Prepare fresh solutions every 24 hours.

Special Note: The concentration of drug required in medicated water must be adequate to compensate for variation in the age of the animal, feedconsumption rate and the environmental temperature and humidity, each of which affects water consumption.

RESIDUE WARNING

RESIDUE WARNING: Do not administer turkeys, cattle or sheep within 5 days of slaughter. Zero-day slaughter withdrawal in swine.  Do not administer to chickens or turkeys producing eggs for human consumption. Do not administer this product with milk replacers. Adminster 1 hour before or 2 hours after feeding milk or milk replacers. A milk discard period has not been estblished for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. For honey bees, the drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.

STORAGE AND HANDLING

STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TETROXY 25 
oxytetracycline hcl powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5025
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	10 g  in 181.5 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-5025-1	181.5 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200146	09/28/2017

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Liberty Pharmaceutical Co., Ltd.		529588375	api manufacture