Label: SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5% solution
- NDC Code(s): 86136-110-47
- Packager: MWI ANIMAL HELATH
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated December 28, 2023
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- WARNINGS AND PRECAUTIONS
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SPL UNCLASSIFIED SECTION
NDC: 86136-110-47
Sulfadimethoxine Concentrated Solution 12.5%
ANTIBACTERIAL
for Use in Drinking Water
For Oral Use in Chickens, Turkeys, and Cattle
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA # 200-165
PROTECT FROM LIGHT
NET CONTENTS: 1 Gallon (3.785 L)
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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, calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.
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PRECAUTIONS
Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°F). 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.
FOR USE IN ANIMALS ONLY
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
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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
Restricted Drug (California) – Use Only as Directed
DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT
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Dosage and Administration
Chickens and Turkeys Treatment Period: 6 consecutive days Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025% Chickens
Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.
Turkeys
Add 1 fl oz (30 mL) 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 1 gallon of Sulfadimethoxine Concentrated Solution 12.5% to 1 gallon of water
Turkeys
Add 2 qts of Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water
*Set proportioner to a feed rate of 1 fl oz (30 mL) of Sulfadimethoxine Stock Solution per gallon 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 gallon of water per 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 gallon of water per 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 1/2 fl oz will medicate one 150-lb animal on maintenance dose.
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INGREDIENTS AND APPEARANCE
SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%
sulfadimethoxine concentrated solution 12.5% solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86136-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) Sulfadimethoxine 125 mg in 1 mL Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86136-110-47 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200165 01/01/2024 Labeler - MWI ANIMAL HELATH (019926120)
