SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%- sulfadimethoxine solution 12.5% solution, concentrate 
Aspen Veterinary Resources, Ltd

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Sulfadimethoxine 12.5%

(sulfadimethoxine)

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 L
(1 GALLON)

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.

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 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.

STORE AT CONTROLLED ROOM TEMPERATURE 20-25°C (68-77°F).
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) – Use Only as Directed

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 http://www.fda.gov/reportanimalae.

Manufactured for:
Aspen Veterinary Resources®, Ltd.
Liberty, MO 64068
www.aspenveterinaryresources.com

Take Time

LOT NO.:                              EXP. DATE:

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 quarts 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 Sulfadimethoxine Concentrated Solution 12.5% to 1 gal of water.

Turkeys

Add 2 gal 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 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 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 medicate one 150-lb animal initially and ½ fl oz will dedicate one 150-lb animal on maintenance dose.

Aspen Sulfadimethoxine CS

SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5% 
sulfadimethoxine solution 12.5% solution, concentrate
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) Sulfadimethoxine3750 mg  in 0.2366 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-555-933.8 L in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20003001/30/2019
Labeler - Aspen Veterinary Resources, Ltd (627265361)

Revised: 6/2023
Document Id: 5c16ee9f-51f1-4519-955c-2d136d92218d
Set id: 82288cbe-dafb-4b87-bf03-f7ee5d50b259
Version: 3
Effective Time: 20230601
 
Aspen Veterinary Resources, Ltd