TERRAMYCIN 200- oxytetracycline powder

Terramycin 200 by

Drug Labeling and Warnings

Terramycin 200 by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Drug Ingredient:

Oxytetracycline (from oxytetracycline dihydrate base) equivalent to

oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 g/lb

CAUTION:

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

CAUTION: For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions–seek prompt medical treatment if such reactions are suspected.

STORE AT OR BELOW 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

Mixing and Use Directions

Thoroughly mix the amount of this Type A medicated article according to the directions below with at least an equal amount by weight of feed formula ingredients prior to blending into a complete feed.

Indications for Use	Oxytetracycline Amount	lb of Terramycin 200/ton
CHICKENS
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline	100-200 g/ton Feed continuously for 7-14 days	0.5-1
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline	400 g/ton Feed continuously for 7-14 days	2
Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline	500 g/ton Feed continuously for 5 days	2.5
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. Do not use in low-calcium feed containing less than 0.55 dietary calcium. Use in such may result in violative residues. Do not administer to chickens producing eggs for human consumption.

TURKEYS
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	100 g/ton Feed continuously for 7-14 days	0.5
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline	200 g/ton Feed continuously for 7-14 days	1
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline	25 mg/lb of body weight daily Feed continuously for 7-14 days	4.151
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.
SWINE
Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	2.52
For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for not more than 14 days	2.52
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For growing cattle (over 400 lb) for reduction of incidence of liver abscesses	75 mg/head/day Feed continuously	0.3753
Prevention and treatment of the early stages of shipping fever complex. (Feed 3-5 days before and after arrival in feedlots.)	0.5-2.0 g/head/day	2.5-103
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	254
SHEEP
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	65
WARNING: 5-day withdrawal before slaughter.
1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day 2Pig consuming 4 lb of complete feed per 100 lb body weight per day 3Include in feed supplement based on consumption of 2 lb of supplement per head per day 4If animal weighs 500 lb, consuming 2 lb of supplement per head per day 5If lamb weighs 60 lb, consuming 1 lb of supplement per head per day

RESTRICTED DRUG (CALIFORNIA) – USE ONALY AS DIRECTED

NOT FOR HUMAN USE

SPL UNCLASSIFIED SECTION

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation, for Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates.

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.7 kg)

NADA #95-143, Approved by FDA

8845000

101-9010-09

Principal Display Panel

INGREDIENTS AND APPEARANCE

TERRAMYCIN 200 
oxytetracycline powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-7868
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	200 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
RICE BRAN (UNII: R60QEP13IC)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
MINERAL OIL (UNII: T5L8T28FGP)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-7868-0	22.7 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA095143	03/31/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)