CALF SCOUR BOLUS- oxytetracycline hydrochloride tablet

Calf Scour Bolus by

Drug Labeling and Warnings

Calf Scour Bolus by is a Animal medication manufactured, distributed, or labeled by Durvet, 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:

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 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 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

683411-02
85229893

Revised 04/2016

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.

NADA 141-002, Approved by FDA

Net Contents: 25 BOLUSES

INGREDIENTS AND APPEARANCE

CALF SCOUR BOLUS 
oxytetracycline hydrochloride tablet

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 30798-740
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: 30798-740-66	25 in 1 BOTTLE, PLASTIC
2	NDC: 30798-740-70	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 - Durvet, Inc. (056387798)