Label: TERRAMYCIN 200 GRANULAR- oxytetracycline powder
- NDC Code(s): 66104-9701-1
- Packager: Phibro Animal Health
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 8, 2023
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- Official Label (Printer Friendly)
- Active Drug Ingredient:
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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 25oC (77oF), EXCURSIONS PERMITTED UP TO 40oC (104oF)
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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 Granular /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 liver condemnation due to 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
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NOT FOR HUMAN USE
RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED
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
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)
Approved by FDA under NADA # 095-143
8846000
102-9142-020-05
- Terramycin 200 Granular
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INGREDIENTS AND APPEARANCE
TERRAMYCIN 200 GRANULAR
oxytetracycline powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-9701 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) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66104-9701-1 22.7 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA095143 01/01/2012 Labeler - Phibro Animal Health (006989008) Registrant - Phibro Animal Health (006989008)