Label: OXY 500 CALF BOLUS- oxytetracycline hydrochloride tablet
- NDC Code(s): 0010-6834-01, 0010-6834-02
- Packager: Boehringer Ingelheim Animal Health USA Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated December 17, 2021
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- SPL UNCLASSIFIED SECTION
OXY 500 CALF 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.
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:
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 OXY 500 CALF 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 OXY 500 CALF BOLUS in conjunction with penicillin.
To report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact Boehringer Ingelheim Animal Health USA Inc. at 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 OXY 500 CALF 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.
- How Supplied
- SPL UNCLASSIFIED SECTION
- Principal Display Panel – 25 bolus bottle label
INGREDIENTS AND APPEARANCE
OXY 500 CALF BOLUS
oxytetracycline hydrochloride tablet
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0010-6834 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE 500 mg Inactive Ingredients Ingredient Name Strength DEXTRATES (UNII: G263MI44RU) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color YELLOW Score 2 pieces Shape OVAL Size 21mm Flavor Imprint Code Oxy500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0010-6834-01 25 in 1 BOTTLE, PLASTIC 2 NDC:0010-6834-02 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141002 05/24/2000 Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)