Sulfadimethoxine Concentrated Solution 12.5%

Manufacturer
Aspen Veterinary Resources Ltd
Effective date
2022-12-09
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:41:46

Label at a glance#

ProductSulfadimethoxine Concentrated Solution 12.5%
Active ingredientSulfadimethoxine
Label structure6 sections

Dosage and administration

Chickens and Turkeys   Treatment Period: 6 consecutive days   Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025%   Chickens Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.   Turkeys Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water.   Automatic Proportioners* Stock Solution To make 2 gallons of Stock Solution ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC: 46066-081-11

Sulfadimethoxine Concentrated Solution 12.5%

ANTIBACTERIAL

for Use in Drinking Water

For Oral Use in Chickens, Turkeys, and Cattle

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

Approved by FDA under ANADA # 200-165

PROTECT FROM LIGHT

NET CONTENTS: 1 Gallon (3.785 L)

INDICATIONS

INDICATIONS & USAGE SECTION

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, calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

PRECAUTIONS

PRECAUTIONS SECTION

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°F). 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.

FOR USE IN ANIMALS ONLY

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

take-time.jpgtake-time.jpg

RESIDUE WARNINGS

RESIDUE WARNING SECTION

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

Restricted Drug (California) – Use Only as Directed

DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Chickens and Turkeys
  Treatment Period: 6 consecutive days
  Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025%

  Chickens

Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.

  Turkeys

Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water.

  Automatic Proportioners* Stock Solution

To make 2 gallons of Stock Solution use:

  Chickens

Add 1 gallon of Sulfadimethoxine Concentrated Solution 12.5% to 1 gallon of water

  Turkeys

Add 2 qts of Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water

*Set proportioner to a feed rate of 1 fl oz (30 mL) of Sulfadimethoxine Stock Solution per gallon 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 gallon of water per 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 winter are based on an estimated water intake of 1 gallon of water per 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 medicate one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sulfadimethoxine-jug.jpgsulfadimethoxine-jug.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46066-081-11Sulfadimethoxine Concentrated Solution 12.5%3785 mL in 1 JUGSOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46066-081SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5% SOLUTION [ASPEN VETERINARY RESOURCES LTD]11 package rows20221212_166380c3-20e9-43b6-addf-80fc9ccb2ab0.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46066-08146066-081-11

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.