SULFADIMETHOXINE SOLUBLE POWDER- sulfadimethoxine sodium powder, for solution

Drug Labeling and Warnings

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Antibacterial Soluble Powder

GENERAL PRECAUTIONS

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Each packet contains 3.34 oz (94.6 g) sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.

PRECAUTIONS

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.

WARNINGS

Not for Use in Humans Keep Out of Reach of Children

Net Contents:

3.77 oz (107 g)

INFORMATION FOR OWNERS/CAREGIVERS

Iss. 11-24
Reorder No. OM300PC

NOT RETURNABLE IF OUTDATED

Approved by FDA under ANADA # 200-443

Made in U.S.A.

Manufactured By:
FIRST PRIORITY, INC., Elgin, IL

www.prioritycare.com

DOSAGE & ADMINISTRATION

Dosage and Administration 

Species	Concentration	Use Directions
Chickens	0.05%	Contents of packet to 50 gallons of water
Turkeys	0.025%	Contents of packet to 100 gallons of water

Automatic proportioners - To make stock solution, add contents of 5 packets to 2 gallons of water for chickens and to 4 gallons of water for turkeys. Set proportioner to feed at rate of 1 fl oz of stock solution per gallon of water.
Treatment Period - 6 consecutive days

Dairy Calves, Dairy Heifers, and Beef Cattle

Dosage: 25mg/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 wt**	(Winter); 1 gal/150 lb body wt**
First Day Add	1 qt; 2 qt; 1 gal	10 gal; 20 gal; 40 gal	7 gal; 14 gal; 28 gal
Next 4 Days Add	1 qt; 2 qt; 1 gal	20 gal; 40 gal; 80 gal	14 gal; 28 gal; 56 gal

*Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water.
** 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. Administer using same mg/lb dosage as outlined above.
*Twenty fluid ounces of cattle stock solution will medicate one-600 lb animal initially or two-600 lb animals on maintenance dose. Contents of packet will medicate six-600 lb animals initially or twelve-600 lb animals on maintenance dose.
Treatment Period - 5 consecutive days

Caution:

Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 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, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

Residue 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.

CONTACT INFORMATION:

To report adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), please contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com.
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

STORAGE:

Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use.

INFORMATION FOR OWNERS/CAREGIVERS

Lot No. Exp. Date

Priority Care is a registered
trademark of First Priority, Inc.

Net Contents: 3.77 oz (107 g)

Pouch Labeling

Case Label

INGREDIENTS AND APPEARANCE

SULFADIMETHOXINE SOLUBLE POWDER 
sulfadimethoxine sodium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58829-348
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFADIMETHOXINE SODIUM (UNII: 49DG2B481W) (SULFADIMETHOXINE - UNII:30CPC5LDEX)	SULFADIMETHOXINE	104.539 g  in 107 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58829-348-03	25 in 1 PAIL
1		107 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200443	03/23/2026

Labeler - First Priority Incorporated (179925722)

Establishment
Name	Address	ID/FEI	Business Operations
First Priority Incorporated		179925722	manufacture, label