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 Manufactu...
www.fda.gov/reportanimalaeConcentrated 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
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.
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.
DOSAGE AND ADMINISTRATION:
Chickens and Turkeys |
Treatment Period: 6 consecutive days |
Dairy Calvers, Dairy Heifers and Beef Cattle |
Treatment Period: 5 consecutive days |
Summer Administration |
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) |
Winter Administration |
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) |
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. |
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 www.fda.gov/reportanimalae
Manufactured By:
Med-Pharmex Incorporated
Pomona, CA 91767 USA
Rev. July 2023
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sulfadimethoxine | ACTIVE INGREDIENT | 30CPC5LDEX | 1 | |
| Sulfadimethoxine | ACTIVE MOIETY | 30CPC5LDEX | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54925-034 | 54925-034-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sulfadimethoxine | 30CPC5LDEX | ACTIB |
Adverse event summaries are temporarily unavailable. Other product information remains available.