SULFADIMETHOXINE- sulfadimethoxine solution 12.5% solution, concentrate

Sulfadimethoxine by

Drug Labeling and Warnings

Sulfadimethoxine by is a Animal medication manufactured, distributed, or labeled by MWI Veterniary Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Concentrated Solution 12.5%

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Antibacterial for use in drinking water

For Oral Use in Chickens, Turkeys and Cattle

ANADA 200-030, Approved by FDA

Protect From Light

FOR USE IN ANIMALS ONLY

NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California)-Use Only as Directed

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.

PRECAUTION

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 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chicken 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 pre-ruminating calves. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.

STORAGE AND HANDLING

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°c (59°-86°f)

TAKE TIME OBSERVE LABEL DIRECTIONS

Dosage and Administration

Chickens and Turkeys
Treatment Period: 6 consecutive days
Recommended Concentration: Chickens – 0.05%; Turkeys – 0.025%
Chickens	Add 1 fl oz (30 mL) to 2 gal of drinking water or 25 fl oz to 50 gal of drinking water.
Turkeys	Add 1 fl oz (30 mL) to 4 quarts of drinking water or 25 fl oz to 100 gal of drinking water.
Automatic Proportioners *Stock Solution – To make 2 gal of stock solution:
Chickens	Add 1 gal of Sulfadimethoxine Concentrated Solution 12.5% to 1 gal of water.
Turkeys	Add 2 qt Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water
*Set proportioner to a feed rate of 1 fl oz of stock solution per gal of water.
Dairy Calves, Dairy Heifers, and Beef Cattle
Treatment Period: 5 consecutive days
Dosage: Initial dose of 25 mg/lb followed by four maintenance dose of 12.5 mg/lb/day. Summer Administration Dosage recommendations for summer are based on an estimated water intake of 1 gal of water for every 100 lb of body weight per day.
	Sulfadimethoxine Concentrated Solution 12.5%
Daily Drinking Water Supply	Initial Dose	Maintenance Dose
25 gal	1 pt (16 fl oz)	1 cup (8 fl oz)
50 gal	1 qt (32 fl oz)	1 pt (16 fl oz)
200 gal	1 gal (128 fl oz)	2 qt (64 fl oz)
Winter Administration
Dosage recommendations for winter are based on an estimated water intake of 1 gal of water for every 150 lb of body weight per day
	Sulfadimethoxine Concentrated Solution 12.5%
Daily Drinking Water Supply	Initial Dose	Maintenance Dose
16 gal	1 pt (16 fl oz)	1 cup (8 fl oz)
33 gal	1 qt (32 fl oz)	1 pt (16 fl oz)
127 gal	1 gal (128 fl oz)	2 qt (64 fl oz)
For individual treatment of cattle.  Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an 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 dedicate one 150-lb animal on maintenance dose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFADIMETHOXINE  
sulfadimethoxine solution 12.5% solution, concentrate

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-751
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX)	Sulfadimethoxine	3750 mg  in 0.2366 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-751-01	3.8 L in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200030	04/01/2017

Labeler - MWI Veterniary Supply, Inc. (019926120)