FDA.reportPublic FDA data

SULFASOL

Manufacturer
Dechra Veterinary Products
Effective date
2023-05-17
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:42:01

Label at a glance#

ProductSULFASOL
Active ingredientSULFADIMETHOXINE SODIUM
Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

(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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dechra Sulfasol Container LabelDechra Sulfasol Container Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17033-428-03SULFASOL107 g in 1 PACKETPOWDER, FOR SOLUTION1071

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17033-428SULFASOL (SULFADIMETHOXINE SODIUM) POWDER, FOR SOLUTION [DECHRA VETERINARY PRODUCTS]11 package rows20230519_ec6dab2e-54e9-4fd1-a3e8-7743453a765b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17033-42817033-428-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFADIMETHOXINE SODIUM49DG2B481WACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.