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Animal NDC 54925-034-11 Sulforal

Sulfadimethoxine Oral Solution

Animal Product Information

Field Name Field Value
Animal NDC Code 54925-034-11
Proprietary Name Sulforal 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 Oral Solution 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
    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.
Active Ingredient(s)
  • Sulfadimethoxine
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 ANADA200251 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.

Sulforal Images

Sulforal 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



Description



Concentrated Solution 12.5%   (3.75g sulfadimethoxine/fl.oz.)

1 Gallon (3.8L)

Protect From Light

Antibacterial for use in drinking water.

For oral use in chickens, turkeys, and cattle.

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

Approved by FDA under ANADA #200-251


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 use in Humans.

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.  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.


Storage And Handling



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

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), 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 Incorporated
Pomona, CA 91767 USA

Rev. July 2023


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