Terramycin Powder

Dosage Form: FOR ANIMAL USE ONLY
Terramycin® 100

(oxytetracycline)

TYPE A MEDICATED ARTICLE

Active Drug Ingredient:

Oxytetracycline (from oxytetracycline dihydrate base) equivalent to

oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb

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 ROOM TEMPERATURE

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 100/ton
CHICKENS
Increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.1-0.5
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	1-2
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	4
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	5
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. In low calcium feeds withdraw 3 days before slaughter. Do not administer to chickens producing eggs for human consumption.
TURKEYS
For growing turkeys for increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.1-0.5
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	100 g/ton Feed continuously for 7-14 days	1
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline	200 g/ton Feed continuously for 7-14 days	2
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	8.31
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
Increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.1-0.5
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	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	52
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For calves (up to 250 lb) for increased rate of weight gain and improved feed efficiency	0.05-0.1 mg/lb of body weight daily Feed continuously	0.05-0.13
For calves (250-400 lb) for increased rate of weight gain and improved feed efficiency	25 mg/head/day Feed continuously	0.254
For growing cattle (over 400 lb) for increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses	75 mg/head/day Feed continuously	0.754
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	5-204
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	505
SHEEP
Increased rate of weight gain and improved feed efficiency	10-20 g/ton Feed continuously	0.1-0.2
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	126
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage.
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 3If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 4Include in feed supplement based on consumption of 2 lb of supplement per head per day 5If animal weighs 500 lb, consuming 2 lb of supplement per head per day 6If lamb weighs 60 lb, consuming 1 lb of supplement per head per day

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

NOT FOR HUMAN USE

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health, for Oxytetracycline HCl

Net Weight 50 lb (22.7 kg)

NADA #95-143, Approved by FDA

8843000

101-9008-07

TERRAMYCIN 100  oxytetracycline  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 66104-7100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE) OXYTETRACYCLINE HYDROCHLORIDE 100 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength MINERAL OIL   CALCIUM CARBONATE   RICE BRAN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66104-7100-0 22.7 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA95143	03/31/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)

Revised: 04/2010Phibro Animal Health