Tetroxy 25: Product Information

TETROXY 25- oxytetracycline hydrochloride powder
Bimeda, Inc.

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

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

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: 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: 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).

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TETROXY 25
oxytetracycline hcl powder
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-5025
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE ANHYDROUS) OXYTETRACYCLINE HYDROCHLORIDE 10 g in 181.5 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61133-5025-1 181.5 g in 1 POUCH None
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 Operations
Bimeda, Inc. 060492923 manufacture
Establishment
Name Address ID/FEI Operations
Yangzhou Liberty Pharmaceutical Co., Ltd. 529588375 api manufacture
Establishment
Name Address ID/FEI Operations
Hebei Jianmin Starch Glucose Co., Ltd. 529723751 api manufacture

Revised: 07/2022 Bimeda, Inc.

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