Label: CALF SCOUR BOLUS- oxytetracycline hydrochloride tablet

  • NDC Code(s): 30798-740-66, 30798-740-70
  • Packager: Durvet, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 6, 2021

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

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 141-002

    For the control and treatment of bacterial enteritis (scours, diarrhea) and bacterial pneumonia in beef and dairy calves.

    Read entire leaflet carefully before using this product.

    Each bolus contains: 500 mg oxytetracycline hydrochloride.

  • Description:

    Calf Scour Bolus is an oral formulation containing oxytetracycline, a broad-spectrum antibiotic that possesses a high order of stability and potent antimicrobial activity, for use in beef and dairy calves.

  • Indications:

    Calf Scour Bolus is recommended for oral administration for the control and treatment of the following diseases of beef and dairy calves caused by organisms sensitive to oxytetracycline: bacterial enteritis (scours, diarrhea) caused by Salmonella typhimurium and Escherichia coli (colibacillosis); bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.

  • Dosage:

    For the control of bacterial enteritis (scours, diarrhea) and bacterial pneumonia in beef and dairy calves: administer orally half a bolus (250 mg oxytetracycline hydrochloride) per 100 lb of body weight every 12 hours (5 mg/lb body weight in divided doses) for up to four consecutive days.

    For the treatment of bacterial enteritis (scours, diarrhea) and bacterial pneumonia in beef and dairy calves: administer orally one bolus (500 mg oxytetracycline hydrochloride) per 100 lb of body weight every 12 hours (10 mg/lb body weight in divided doses) for up to four consecutive days.

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

  • Residue Warning:

    There is no pre-slaughter withdrawal period when used at the recommended dosage level. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

  • Precautions:

    Exceeding the recommended dosage level of one bolus (500 mg oxytetracycline hydrochloride) per 100 lb body weight every 12 hours, or administration at the recommended level for more than four 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 Calf Scour Bolus.

    If any unusual reactions are noted, discontinue use of the drug immediately and call a veterinarian.

    Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Calf Scour Bolus in conjunction with penicillin.

    To report suspected adverse reactions, to obtain a Safety Data Sheet (SDS) or for technical assistance, call 1-888-637-4251.

    For additional information about adverse drug experience reporting for animal drugs, contact FDA by telephone at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • 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 disease caused by oxytetracycline susceptible organisms, most animals treated with Calf Scour Bolus show a noticeable improvement within 24 to 48 hours. 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.

  • Storage:

    Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F).

  • How Supplied:

    Calf Scour Bolus is available in 25 and 100 bolus containers.

    NDC 30798-740-66 – 25 boluses
    NDC 30798-740-70 – 100 boluses

  • SPL UNCLASSIFIED SECTION


    Manufactured for:
    Durvet, Inc.
    Blue Springs, MO 64014

    683411-03
    87018334

    Revised 09/2019

  • Principal Display Panel – 25 Bolus Bottle Label

    NDC 30798-740-66

    Calf Scour Bolus

    oxytetracycline HCl, 500 mg

    For the control and treatment of bacterial enteritis (scours, diarrhea) and bacterial pneumonia in beef and dairy calves.

    Approved by FDA under NADA # 141-002

    Net Contents: 25 BOLUSES

    Picture of bottle label 25 boluses
  • INGREDIENTS AND APPEARANCE
    CALF SCOUR BOLUS 
    oxytetracycline hydrochloride tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-740
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRATES (UNII: G263MI44RU)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeOVALSize21mm
    FlavorImprint Code Oxy500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30798-740-6625 in 1 BOTTLE, PLASTIC
    2NDC:30798-740-70100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14100205/24/2000
    Labeler - Durvet, Inc. (056387798)