SULFORAL- sulfadimethoxine oral solution solution

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

Concentrated Solution 12.5%

Antibacterial for use in drinking water.

3.75g sulfadimethoxine/fl.oz. / 1 Gallon (3.8L)

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

Protect From Light - For oral use in chickens, turkeys, and cattle.

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

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 Human Use.

CONTACT INFORMATION:To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472.

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

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 & 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 water

Dairy 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.

STORAGE AND HANDLING

STORAGE:   Store at Controlled Room Temperature 15°-30°C (59°-86°F).

Manufactured for:
Dechra Veterinary Products, LLC
Overland Park, KS 66211

Rev. 05/2023

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFORAL 
sulfadimethoxine oral solution solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-415
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: 17033-415-01	3785 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200251	05/30/2023

Labeler - Dechra Veterinary Products (362142734)