Sulfadimethoxine

Manufacturer
MWI Veterinary Supply, Inc.
Effective date
2023-06-05
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:42:04

Label at a glance#

ProductSulfadimethoxine
Active ingredientSulfadimethoxine
Label structure10 sections

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) to 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 Sulfad...

Storage and handling

STORE AT CONTROLLED ROOM TEMPERATURE 20 – 25°C (68 – 77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Sulfadimethoxine

Solution

Concentrated Solution 12.5%

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

Antibacterial

For use in drinking water

For Oral Use in Chickens, Turkeys, and Cattle

3.75 g sulfadimethoxine/fl oz

Protect From Light

Approved by FDA under ANADA # 200-030

Net Contents: 3.8 Liters (1 Gallon)

INDICATIONS & USAGE SECTION

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.

GENERAL PRECAUTIONS SECTION

PRECAUTION: 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 re-evaluate diagnosis. 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, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

RESIDUE WARNING SECTION

RESIDUE 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.

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE 20 – 25°C (68 – 77°F).

USER SAFETY WARNINGS SECTION

NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) – Use Only as Directed.

Take TimeTake Time

ADVERSE REACTIONS SECTION

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

Lot No.:                  Exp. Date:                   Manufactured for: MWI
                                                                  Boise, ID 83705
                                                                  www.VetOne.net

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Chickens and Turkeys
Treatment Period: 6 consecutive days
Recommended Concentration: Chickens – 0.05%; Turkeys – 0.025%
ChickensAdd 1 fl oz (30 mL) to 2 gal of drinking water or 25 fl oz to 50 gal of drinking water.
TurkeysAdd 1 fl oz (30 mL) to 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:
ChickensAdd 1 gal of Sulfadimethoxine Concentrated Solution 12.5% to 1 gal of water.
TurkeysAdd 2 qt of Sulfadimethoxine 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 Calves, Dairy Heifers, and Beef Cattle
Treatment Period: 5 consecutive days

Dosage: Initial dose of 25 mg/lb followed by four maintenance doses 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 SupplyInitial DoseMaintenance Dose
25 gal1 pt (16 fl oz)1 cup (8 fl oz)
50 gal1 qt (32 fl oz)1 pt (16 fl oz)
200 gal1 gal (128 fl oz)2 qt (64 fl oz)
Winter Administration
Dosage recommendations for winter 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 SupplyInitial DoseMaintenance Dose
16 gal1 pt (16 fl oz)1 cup (8 fl oz)
33 gal1 qt (32 fl oz)1 pt (16 fl oz)
127 gal1 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 medicate one 150-lb animal initially and ½ fl oz will medicate one 150-lb animal on maintenance dose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sulfadimethoxine 1 GallonSulfadimethoxine 1 Gallon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-751-01Sulfadimethoxine3.8 L in 1 JUGSOLUTION, CONCENTRATE3.85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-751SULFADIMETHOXINE (SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%) SOLUTION, CONCENTRATE [MWI VETERINARY SUPPLY, INC.]51 package rows20230609_7d5cc60e-7a16-48d7-854a-723dc1faddbf.zip

Products#

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DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-75113985-751-01

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
Sulfadimethoxine30CPC5LDEXACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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