Label: SULFASOL- sulfadimethoxine sodium powder, for solution
- NDC Code(s): 54925-035-37
- Packager: Med-Pharmex, Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
Drug Label Information
Updated June 23, 2023
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INDICATIONS & USAGE
(sulfadimethoxine)
AntibacterialCAUTION:Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA #200-238
Each packet contains 3.34 oz. (94.6 g) sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.
Restricted Drug (California) - Use Only as Directed. Not for Human Use.
For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera.
For 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 Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Net Wt.: 3.77 oz (107g)
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DOSAGE & ADMINISTRATION
SULFADIMETHOXINE
SOLUBLE POWDER
Dosage and Administration:
Species
Concentration
Use of Directions
Chickens
0.05%
Contents of packet to 50 gal of water
Turkeys
0.025%
Contents of packet to 100 gal of water
Automatic Proportioners: To make stock solution, add contents of 5 packets to 2 gal of water for chickens and to 4 gal of water for turkeys. Set proportioner to feed at a rate of 1 fl oz stock solution per gal of water.
Treatment Period: 6 consecutive days
Dairy Calves, Dairy Heifers, and Beef Cattle
Dosage: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days
Sulfadimethoxine in Water
Water Consumption
Amount of Stock Solution
for Cattle*
(Summer)*
1 gal/100 lb body weight**
(Winter)*
1 gal/150 lb body weight**
First Day Add
1 qt
10 gal
7 gal
2 qt
20 gal
14 gal
1 gal
40 gal
28 gal
Next 4 Days Add
1 qt
20 gal
14 gal
2 qt
40 gal
28 gal
1 gal
80 gal
56 gal
*Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water.
*Twenty fl oz of cattle stock solution will medicate 1-600 lb animal initially or 2-600 lb animals on maintenance dose. Contents of packet will medicate 6-600 lb animals initially or 12-600 lb animals on maintenance dose.
**This dosage recommendation is based on a water consumption of 1 gal per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30%-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake.
For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.
Treatment Period: 5 consecutive days
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WARNINGS AND PRECAUTIONS
Caution: Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. 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, reevaluate diagnosis. Treatment should not be continued beyond 5 days.Warning:
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
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GENERAL PRECAUTIONS
CONTACT INFORMATION:To report adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), please 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, Inc., Pomona CA 91767Rev. 06/2023
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INGREDIENTS AND APPEARANCE
SULFASOL
sulfadimethoxine sodium powder, for solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54925-035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFADIMETHOXINE SODIUM (UNII: 49DG2B481W) (SULFADIMETHOXINE - UNII:30CPC5LDEX) SULFADIMETHOXINE SODIUM 94.6 g in 107 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54925-035-37 107 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200238 07/28/1998 Labeler - Med-Pharmex, Inc (025353699)
