Label: SULFORAL- sulfadimethoxine oral solution solution
- NDC Code(s): 54925-034-11
- Packager: Med-Pharmex, Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated July 11, 2023
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DESCRIPTION
Concentrated Solution 12.5% (3.75g sulfadimethoxine/fl.oz.)
1 Gallon (3.8L)
Protect From Light
Antibacterial for use in drinking water.
For oral use in chickens, turkeys, and cattle.
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA #200-251
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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.
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WARNINGS AND PRECAUTIONS
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 reevaluate 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, reevaluate diagnosis. Treatment should not be continued beyond 5 days.
Restricted Drug (California) - Use Only as Directed. Not for use in Humans.
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. DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT.
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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) 4 gal 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 Sulforal Concentrated Solution 12.5% to 1gal of water.
Turkeys Add 2 qt of Sulforal 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 waterDairy Calvers, 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 summer 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 medicated one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.
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STORAGE AND HANDLING
STORAGE: Store at Controlled Room Temperature 15°-30°C (59°-86°F)
CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae
Manufactured By:
Med-Pharmex Incorporated
Pomona, CA 91767 USARev. July 2023
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SULFORAL
sulfadimethoxine oral solution solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54925-034 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54925-034-11 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200251 09/01/2011 Labeler - Med-Pharmex, Inc (025353699)
