Label: TETROXY 343- oxytetracycline hcl powder

Tetroxy® 343
(oxytetracycline hydrochloride)
Soluble Powder

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

A broad spectrum ANTIBIOTIC

FOR CONTROL AND TREATMENT OF SPECIFIC DISEASES IN POULTRY, CATTLE, SHEEP, SWINE AND HONEY BEES.
FOR THE MARKING OF SKELETAL TISSUES IN FINFISH FRY AND FINGERLINGS AS AN AID IN IDENTIFICATION.

This pouch contains 1,715 grams of oxytetracycline hydrochloride.

For oral use only in poultry, cattle, sheep, swine and honey bees.
Fish should be treated by immersion.

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

Approved by FDA under ANADA # 200-247

INDICATIONS AND DIRECTIONS FOR USE:

POULTRY

For the control of the following poultry diseases caused by organisms susceptible to oxytetracycline: Add the following amount to two gallons of stock solution when proportioner is set to meter at the rate of one ounce per gallon. The enclosed measuring cup holds 68 g (2.4 oz) of product when leveled at the 80 mL mark.

Medicate continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. If improvement is not noted within 24-48 hours, consult a poultry diagnostic laboratory or poultry pathologist to determine diagnosis and advice on dosage. See Residue Warnings.

For the control and treatment of the following diseases caused by organisms susceptible to oxytetracycline:

ADVERSE REACTIONS: Oxytetracycline hydrochloride will acidify the water. The pH should be maintained at an acceptable level for fish by the addition of a buffer. Monitor water quality and temperature.

DISPOSAL OF TREATED WATER: Do not discharge marking immersion water containing oxytetracycline into surface waters.

PRECAUTION: 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, feed consumption rate and the environmental temperature and humidity, each of which affects water consumption.

RESIDUE WARNINGS: Use as sole source of oxytetracycline. Do not administer to 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 or milk replacers. Administer 1 hour before or 2 hours after feeding milk or milk replacers. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. An additional withdrawal time beyond the grow-out period is not needed for fish. 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.

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

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).