Label: TERRAMYCIN 200 GRANULAR- oxytetracycline powder

  • 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

If you are a consumer or patient please visit this version.

  • 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 25oC (77oF), EXCURSIONS PERMITTED UP TO 40oC (104oF)

  • 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

  • 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

    Terramycin 200 GranularTerramycin 200 Granular Label

  • INGREDIENTS AND APPEARANCE
    TERRAMYCIN 200 GRANULAR 
    oxytetracycline powder
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:66104-9701
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE200 g  in 0.45 kg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    RICE BRAN (UNII: R60QEP13IC)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66104-9701-122.7 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA09514301/01/2012
    Labeler - Phibro Animal Health (006989008)
    Registrant - Phibro Animal Health (006989008)