OXY 500 CALF BOLUS- oxytetracycline hydrochloride tablet

Oxy 500 Calf Bolus by

Drug Labeling and Warnings

Oxy 500 Calf Bolus by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Vetmedica, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NADA 141-002, Approved by FDA

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:

Oxy 500 Calf 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:

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.

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 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 reactions, to obtain a Material Safety Data Sheet (MSDS) or for technical assistance, call 1-866-638-2226.

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.

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:

Oxy 500 Calf Bolus is available in 25 and 100 bolus containers.

NDC: 0010-6834-01 – 25 boluses
NDC: 0010-6834-02 – 100 boluses

683401-03
83759543
80442726, R.0

Revised 07/2012

Principal Display Panel – 25 bolus bottle label

NDC: 0010-6834-01

Oxy 500 Calf Bolus

(oxytetracycline HCl), 500 mg

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

Net Contents: 25 boluses

NADA 141-002, Approved by FDA

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 Vetmedica, Inc. (007134091)