TETROXY 343- oxytetracycline hcl powder

Tetroxy 343 by

Drug Labeling and Warnings

Tetroxy 343 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

ANADA 200-247, Approved by FDA

INDICATIONS & USAGE

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.

CHICKENS	DOSAGE	SCOOPS/2 GALLONS STOCK SOLUTION
Infectious synovitis caused by Mycoplasma synoviae.	200-400 mg/gal	1-2
Chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli.	400-800 mg/gal	2-4
Fowl cholera caused by Pasteurella multocida.	400-800 mg/gal	2-4
TURKEYS
Hexamitiasis caused by Hexamita meleagridis.	200-400 mg/gal	1-2
Infectious synovitis caused by Mycoplasma synoviae.	400 mg/gal	2
Growing Turkeys-Complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).	25 mg/lb body weight daily	varies with age & water consumption (1 pound will treat 13,720 pounds of turkeys.)

INDICATIONS & USAGE

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:

• SWINE: DOSAGE
• Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis. Bacterial pneumonia caused by Pasteurella multocida. For Breeding Swine: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona.: Administer in the drinking water at a level of 10 mg oxytetracycline hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings.
• CALVES, BEEF CATTLE AND NON-LACTATING CATTLE: DOSAGE
• Bacterial enteritis caused by Escherichia coli. Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.: Administer in the drinking water at a level of 10 mg oxytetracycline hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings.
• SHEEP: DOSAGE
• Bacterial enteritis caused by Escherichia coli. Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.: Administer in the drinking water at a level of 10 mg oxytetracycline hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings.
• HONEY BEES: DOSAGE
• For control of American Foulbrood caused by Paenibacillus larvae susceptible to oxytetracycline.:

  200 mg/colony

  Administer in 3 applications of sugar syrup or 3 dustings at 4 to 5 day intervals. Apply dust on the outer parts or ends of the frames. See Residue Warnings.

• FISH: DOSAGE
• For the marking of skeletal tissues in finfish fry and fingerlings as an aid in identification.: Immerse fry or fingerling finfish in 200 to 700 mg OTC (buffered)/liter of water for 2-6 hours. Solution should be tested on a small number of fish before full-scale use. Once mixed with water, solution should be used immediately. See Residue Warnings.

ADVERSE REACTIONS

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.

PRECAUTIONS

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 WARNING

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.

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 343 
oxytetracycline hcl powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-3401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	102.4 g  in 135.5 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-3401-1	135.5 g in 1 POUCH
2	NDC: 61133-3401-2	272.2 g in 1 POUCH
3	NDC: 61133-3401-3	2260 g in 1 PAIL
4	NDC: 61133-3401-4	907.2 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200247	07/16/2013

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

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