SULFADIMETHOXINE- sulfadimethoxine oral solution solution 
Aspen Veterinary Resources Ltd

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Sulfadimethoxine Concentrated Solution 12.5%

NDC# 46066-083-11
Protect From Light

Antibacterial

3.75g sulfadimethoxine/fl.oz.
Antibacterial for use in drinking water

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

For oral use in chickens, turkeys, and cattle

ACTIVE DRUG INGREDIENT: Sulfadimethoxine.

INACTIVE DRUG INGREDIENT: Disodium Edetate, Sodium Bisulfite, Sodium Hydroxide, Purified Water QS.

Manufactured for:
Aspen Veterinary Resources Ltd.
Liberty, MO 64068, USA

www.aspenveterinaryresources.com

A255MP                  Rev. 02/2017

ANADA #200-251           

Approved by FDA

NET CONTENTS:

1Gallon (3.8 L)


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.


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.

TAKE TIME OBSERVE LABEL DIRECTIONS

Restricted Drug (California) - Use Only as Directed. Not for Human Use.

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

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

DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

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 Sulfadimethoxine Concentrated Solution 12.5% to 1gal of water.
 Turkeys   Add 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 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.

Lot # / Exp.Date

Sulforal 1Gallon Aspen Label

Add image transcription here...

SULFADIMETHOXINE 
sulfadimethoxine oral solution solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-083
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfadimethoxine (UNII: 30CPC5LDEX) (Sulfadimethoxine - UNII:30CPC5LDEX) Sulfadimethoxine125 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-083-113785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20025109/01/201109/25/2023
Labeler - Aspen Veterinary Resources Ltd (627265361)

Revised: 9/2023
 
Aspen Veterinary Resources Ltd