Drug Facts

Product Type: OTC ANIMAL DRUG LABEL
Autor Name: Teva Animal Health, Inc.
Code Source: 59130-662
Route of Administration: ORAL

Sulfadimethoxine

Generic: Sulfadimethoxine

Ingredients:

SULFADIMETHOXINE SULFADIMETHOXINE : Active ingredient - basis of strength - 125 mg in 1 mL

Package Description:

3785 mL in 1 JUG

Sulfadimethoxine 12.5 % Oral Solution,
Antibacterial For Oral Use in Drinking Water
3.75g sulfadimethoxine/fl oz
Protect From Light
For Oral Use in Chickens, Turkeys, and Cattle
ANADA 200-192, Approved by FDA

Active ingredient

Sulfadimethoxine Base

Inactive Ingredients

Sodium Hydroxide, Sodium Metabisulfite, Edetate Disodium, Purified Water, and Hydrochloric Acid .

Indications:

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.

Cautions

CAUTION: Store at room temperature; if freezing occurs, thaw before 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 0.0.25%) 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:

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 pre-ruminating calves. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.

Storage

Store at controlled room temperature 20 °-25°C (68°-77°F)

Warnings:

RESTRICTED DRUG (CALIFORNIA)
USE ONLY AS DIRECTED
NOT FOR HUMAN USE

Dosage and Administration

Dosage and Administration Table Dosage and Administration Table

	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 gal Sulfadimethoxine 12.5% Drinking Water Solution Concentrate to 1 gal of water
TURKEYS	Add 2 qts Sulfadimethoxine 12.5% Drinking Water Solution Concentrate 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	25 mg/lb first day	WATER CONSUMPTION
DAIRY HEIFERS	followed by	(SUMMER)	(WINTER)
AND BEEF	12.5 mg/lb/day	1 gallon/ †	1 gallon/ †
CATTLE	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.