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Animal NDC 54925-035-37 Sulfasol

Sulfadimethoxine Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 54925-035-37
Proprietary Name Sulfasol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sulfadimethoxine Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Med-pharmex, Inc
Product Type Prescription Animal Drug
Usage Information
    (sulfadimethoxine)AntibacterialCAUTION:Federal law restricts this drug to use by or on the order of a licensed veterinarian.Approved by FDA under ANADA #200-238Each packet contains 3.34 oz. (94.6 g) sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.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.Net Wt.: 3.77 oz (107g)
Active Ingredient(s)
  • Sulfadimethoxine Sodium
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200238 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Sulfasol Images

Sulfasol Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications & Usage



(sulfadimethoxine)
Antibacterial

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

Approved by FDA under ANADA #200-238

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

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.

Net Wt.: 3.77 oz (107g)


Dosage & Administration



SULFADIMETHOXINE

SOLUBLE POWDER

Dosage and Administration:

Species

Concentration

Use of Directions

Chickens

0.05%

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.

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


General Precautions



CONTACT INFORMATION:To report adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), please contact MED-PHARMEX at (800) 587-4306.
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

MANUFACTURED BY: Med-Pharmex, Inc., Pomona CA 91767

Rev. 06/2023


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.