Label: SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%- sulfadimethoxine solution 12.5% solution, concentrate
- NDC Code(s): 46066-555-93
- Packager: Aspen Veterinary Resources, Ltd
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated June 1, 2023
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SPL UNCLASSIFIED SECTION
Sulfadimethoxine 12.5%
(sulfadimethoxine)
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
3.75 g sulfadimethoxine/fl oz
Protect From LightApproved by FDA under ANADA # 200-030
NET CONTENTS:
3.8 L
(1 GALLON) -
INDICATIONS & USAGE
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. -
WARNINGS AND PRECAUTIONS
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. 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.
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RESIDUE WARNING
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
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ADVERSE REACTIONS
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
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DOSAGE & ADMINISTRATION
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 gal of Sulfadimethoxine Concentrated Solution 12.5% to 6 qt 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 doses 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.
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INGREDIENTS AND APPEARANCE
SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%
sulfadimethoxine solution 12.5% solution, concentrateProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46066-555 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:46066-555-93 3.8 L in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200030 01/30/2019 Labeler - Aspen Veterinary Resources, Ltd (627265361)
