Oxy 500 Calf Bolus

Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Effective date
2021-12-17
Label type
OTC ANIMAL DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:22:15

Label at a glance#

ProductOxy 500 Calf Bolus
Active ingredientOXYTETRACYCLINE HYDROCHLORIDE
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

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:

DESCRIPTION SECTION

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:

VETERINARY INDICATIONS 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.

Dosage:

DOSAGE & ADMINISTRATION SECTION

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:

RESIDUE WARNING SECTION

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:

PRECAUTIONS SECTION

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:

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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:

STORAGE AND HANDLING SECTION

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

How Supplied

SPL UNCLASSIFIED SECTION

OXY 500 CALF BOLUS is available in 25 and 100 bolus containers.

NDC 0010-6834-01 - 25 boluses

NDC 0010-6834-02 - 100 boluses

SPL UNCLASSIFIED SECTION

Marketed by:

Boehringer Ingelheim Animal Health USA Inc.

Duluth, GA 30096

683401-04

87018350

Rev: 08/19

Principal Display Panel – 25 bolus bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Approved by FDA under NADA # 141-002

Picture of 25 ct bolus container label.
Picture of 25 ct bolus container label.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYTETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENT4U7K4N52ZM3
OXYTETRACYCLINE ANHYDROUSACTIVE MOIETYSLF0D9077S3

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0010-68340010-6834-01, 0010-6834-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.