Label: TERRAMYCIN SCOURS- oxytetracycline hydrochloride tablet

  • NDC Code(s): 54771-1203-1, 54771-1203-2
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 5, 2019

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  • SPL UNCLASSIFIED SECTION

    Each tablet contains 250 mg of oxytetracycline HCl.

    A broad-spectrum antibiotic for use in beef and dairy calves

    Read Entire Package Outsert Carefully Before Using This Product

  • DESCRIPTION

    Terramycin Scours Tablets is an oral formulation containing oxytetracycline, a versatile, broad-spectrum antibiotic that possesses potent antimicrobial activity, for use in beef and dairy calves.

  • INDICATIONS AND USAGE

    Terramycin Scours Tablets are recommended for oral administration for the control and treatment of the following diseases in beef and dairy calves caused by organisms sensitive to oxytetracycline: bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.

  • WARNINGS

    Discontinue treatment at least 7 days prior to slaughter. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

  • PRECAUTIONS

    Exceeding the recommended dosage level of 2 tablets per 100 lb of body weight every 12 hours (10 mg/lb of body weight daily), or administering at this recommended level for more than 4 consecutive days, may result in antibiotic residues beyond the withdrawal time.

    Organisms may vary in their degree of susceptibility to any chemotherapy. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reexamined.

    Rarely do side reactions or allergic manifestations occur in calves treated with Terramycin. If any unusual reactions are noted, discontinue use of the drug immediately and call a veterinarian.

    Since bacteriostatic drugs may interfere with the bacterial action of penicillin, it is advisable to avoid giving Terramycin in conjunction with penicillin.

  • DOSAGE AND ADMINISTRATION

    For control of bacterial enteritis and bacterial pneumonia orally administer 1 tablet per 100 lb of body weight every 12 hours (5 mg/ lb of body weight daily in divided doses) for up to 4 consecutive days.

    For treatment of bacterial enteritis and bacterial pneumonia orally administer 2 tablets per 100 lb of body weight every 12 hours (10 mg/lb of body weight daily in divided doses) for up to 4 consecutive days.

    Dosage should continue until the animal returns to normal and for 24–48 hours after symptoms have subsided. Treatment should not exceed 4 consecutive days.

    Care of Sick Animals

    The use of antibiotics in the management of disease is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by oxytetracycline-susceptible organisms, most animals treated with Terramycin Scours Tablets show a noticeable improvement within 24–48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be reevaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.

  • RECOMMENDED STORAGE

    Store below 25°C (77°F).

  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Restricted Drug (California)—Use Only as Directed

    Not For Human Use

    image

    Approved by FDA under NADA # 011-060

    Product of China

    zoetis

    Distributed by:

    Zoetis Inc.
    Kalamazoo, MI 49007

    40026205
    Revised: January 2019

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Label

    24 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    TERRAMYCIN  SCOURS
    oxytetracycline hydrochloride tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-1203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE ANHYDROUS250 mg
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeOVAL (Bolus) Size26mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1203-124 in 1 BOTTLE
    2NDC:54771-1203-2100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01106006/03/1981
    Labeler - Zoetis Inc. (828851555)