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Sulfadimethoxine Oral

Bayer HealthCare LLC

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

FRONT PANEL
INDICATIONS;
CAUTION:
RESIDUE WARNINGS:
STORAGE:
SULFADIMETHOXINE ORAL DOSAGE AND ADMINISTRATION:
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FULL PRESCRIBING INFORMATION

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NDC 0859-2362-01

SULFADIMETHOXINE 12.5% Oral Solution

Antibacterial For Use in Drinking Water

3.75g sulfadimethoxine/fl oz

Protect From Light

For Oral Use in Chickens, Turkeys, and Cattle

Net Contents: 1 gal (3.8L)

ANADA 200-192, Approved by FDA

Multi-Species

INDICATIONS;

BROILER AND REPLACEMENT CHICKENS-Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Meat Producing Turkeys-Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

Dairy Calves, Dairy Heifers, and Beef Cattle- Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

CAUTION:

Store at room temperature; if freezing occurs, thaw and shake well prior to using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily.

Chickens and Turkeys- If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Cattle- During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

RESIDUE WARNINGS:

Chickens and Turkeys- Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.

Cattle- Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in preruminating calves. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.

STORAGE:

Store at controlled room temperature 20°-25°C (68°-77°F). Shake well before use

RESTRICTED DRUG (CALIFORNIA)

USE ONLY AS DIRECTED

NOT FOR HUMAN USE

DOSAGE AND ADMINISTRATION:

	TREATMENT PERIOD – 6 consecutive days
Species	Concentration		Use Directions
CHICKENS	0.05%		Add 1 fl oz* to 2 gallons of drinking water or
			25 fl oz to 50 gallons of drinking water
TURKEYS	0.025%		Add 1 fl oz* to 4 gallons of drinking water or
			25 fl oz to 100 gallons of drinking water

Automatic Proportioners **Stock Solution-To make 2 gallons of Stock Solution use:
CHICKENS	Add 1gal Sulfadimethoxine 12.5% Drinking Water Solution to 1 gal of water
TURKEYS	Add 2 qts Sulfadimethoxine 12.5% Drinking Water Solution to 6 qts of water

	* 1 fl oz Sulfadimethoxine 12.5% Oral Solution -30mL or 2 tablespoonfuls.
	**Set proportioner to a feed rate of 1 fl oz of Sulfadimethoxine Stock Solution per gallon of water.
	TREATMENT PERIOD – 5 consecutive days
	DOSAGE:		SULFADIMETHOXINE IN WATER
DAIRY CALVES DAIRY HEIFERS AND BEEF CATTLE	25 mg/lb first day		WATER CONSUMPTION
	followed by		(SUMMER)	(WINTER)
	12.5 mg/lb/day		1 gallon/†	1 gallon/†
	for 4 days.		100 lb. b.w.	150 lb. b.w.

	FIRST DAY ADD:	1 pint (16 fl oz) to:	25 gallons	16 gallons
		1 quart (32 fl oz) to:	50 gallons	33 gallons
		1 gallon (128 fl oz) to:	200 gallons	127 gallons
	NEXT 4 ADD:	1 pint (16 fl oz) to:	50 gallons	33 gallons
		1 quart (32 fl oz) to:	100 gallons	66 gallons
		1 gallon (128 fl oz) to:	400 gallons	266 gallons

† Dosage recommendations are based on an estimated summer water intake of 1 gal of water for every 100 lb of body weight per day, and an estimated winter water intake of 1 gal of water for every 150 lb of body weight per day.
For individual treatment of cattle, Sulfadimethoxine 12.5% Oral Solution may be given as a drench. Administer using initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150 lb animal initially and ½ fl oz will medicate one 150 lb animal on maintenance dose.

Bayer and the Bayer Cross are registered trademarks of Bayer. Manufactured for Bayer HealthCare LLC Shawnee Mission, KS 66201

81583455,R.O 200106.00

BARCODE

7-2408983455-3

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