Terramycin Powder

Generic Name: oxytetracycline 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 Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:66104-7100-0 22.7 kg in 1 BAG
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: 04/2010
 
Phibro Animal Health



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