SULFADIMETHOXINE- sulfadimethoxine oral solution solution

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

NDC: 13985-004-11
Protect From Light
Antibacterial for use in drinking water
Concentrated Solution 12.5%

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

3.75g sulfadimethoxine/fl.oz.

For oral use in chickens, turkeys, and cattle

1 Gallon (3.8L)

Manufactured for: MWI
Boise, ID 83705

ANADA #200-251
Approved BY FDA

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.

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

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

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.

Lot # / Exp.Date

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFADIMETHOXINE 
sulfadimethoxine oral solution solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-004
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: 13985-004-11	3785 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200251	02/14/2017

Labeler - MWI (019926120)