SULFASOL- sulfadimethoxine sodium powder, for solution

SULFASOL by

Drug Labeling and Warnings

SULFASOL by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

(Brand of Sulfadimethoxine)

Antibacterial

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

Approved by FDA under ANADA #200-238

Restricted Drug (California) - Use Only as Directed. Not for Human Use.

Net Wt.: 3.77 oz (107g)

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

INDICATIONS & USAGE

INDICATIONS FOR 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.

DOSAGE & ADMINISTRATION

				SULFADIMETHOXINE
				SOLUBLE POWDER
Dosage and Administration:
Species		Concentration				Use of Directions
Chickens		0.050%				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

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.

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 pre-ruminating calves.

Do Not Use in Calves to be Processed For Veal

GENERAL PRECAUTIONS

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

SULFASOL is a trademark of Med-Pharmex, Inc.

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

Rev. 05/2023

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFASOL  
sulfadimethoxine sodium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-428
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: 17033-428-03	107 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200238	05/17/2023

Labeler - Dechra Veterinary Products (362142734)