Label: TERRAMYCIN 200- oxytetracycline hydrochloride powder

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/14

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

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  • 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.

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  • 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 200/ton

    CHICKENS

    Increased rate of weight gain and improved feed efficiency

    10-50 g/ton

    Feed continuously

    0.05-0.25

    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. 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

    0.05-0.25

    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

    Increased rate of weight gain and improved feed efficiency

    10-50 g/ton

    Feed continuously

    0.05-0.25

    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 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

    0.025-0.053

    For calves (250-400 lb) for increased rate of weight gain and improved feed efficiency

    25 mg/head/day

    Feed continuously

    0.1254

    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

    0.3754

    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

    2.5-104

    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

    255

    SHEEP

    Increased rate of weight gain and improved feed efficiency

    10-20 g/ton

    Feed continuously

    0.05-0.1

    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

    66

    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

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  • NOT FOR HUMAN USE

    RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

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  • 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, for Oxytetracycline HCl

    Net Weight 50 lb (22.7 kg)

    NADA #95-143, Approved by FDA

    7870000

    101-9010-07

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    TERRAMYCIN 200 
    oxytetracycline powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:66104-7868
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE ANHYDROUS) OXYTETRACYCLINE HYDROCHLORIDE 200 g  in 0.45 kg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    RICE BRAN  
    SODIUM ALUMINIUM SILICATE  
    MINERAL OIL  
    SUCROSE  
    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)
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