SULFADIMETHOXINE- sulfadimethoxine powder, for solution 
Aspen Veterinary Resources

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Sulfadimethoxine Soluble Powder

Antibacterial

For Oral Use in Chickens, Turkeys and Cattle

INDICATIONS:

For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

For Dairy Calves, Dairy Heifers, and Beef Cattle - Use for the treatment of shipping fever complex, bacterial pneumonia, calf diptheria, and foot rot.

Each packet contains 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Restricted Drug - Use Only as Directed (California)

ANADA 200-376, Approved by FDA

NET WEIGHT: 107 g (3.77 oz)

DOSAGE AND ADMINISTRATION:

Species Concentration Use Directions
Chickens0.05%Contents of packet to 250 gallons of water
Turkeys0.025%Contents of packet to 500 gallons of water

If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 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.

Automatic Proportioners - To make stock solution, add contents of 5 packet to 2 gallons of water for chickens and to 4 gallons of water for turkeys. Set proportioner to feed at a rate of 1 fl oz of stock solution per gallon of water.

TREATMENT PERIOD - 6 consecutive days

DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE

DOSAGE: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days.

 SulfaMed-G in Water                    Water Consumption  
Amount of Stock Solution for Cattle*(Summer) 1 gallon/**100 lb body weight (Winter) 1 gallon/**150 lb body weight
 First Day Add 1 quart 10 gallons 7 gallons
 2 quart 20 gallons 14 gallons
 3 gallon 40 gallons 28 gallons
 Next 4 Days Add 1 quart 20 gallons 14 gallons
 2 quart 40 gallons 28 gallons
 1 gallon 80 gallons 56 gallons

*Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gallons of water.


** This dosage recommendation is based on a water consumption rate of 1 gallon per 100lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake.

For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.

Administer using same mg/lb dosage as outlined above.

Twently fl. oz. of cattle stock solution will medicate one-600 lb animal initially or two-600 lb animals on a maintenance dose. Contents of packet will medicate six-600 lb animals initially or twelve-600 lb animals on a maintenance dose.

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°C - 25°C (68°F-77°F), excursions permitted between 15°C and 30°C (59°F - 86°F).

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SULFADIMETHOXINE 
sulfadimethoxine powder, for solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-128
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFADIMETHOXINE (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) SULFADIMETHOXINE94.6 g  in 107 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-128-01107 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20037609/21/201208/27/2015
Labeler - Aspen Veterinary Resources (627265361)
Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda Inc., Division of Cross Vetpharm Group060492923manufacture
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Works POLPHARMA S.A.422195139api manufacture
Establishment
NameAddressID/FEIBusiness Operations
SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO., LTD.544646342api manufacture
Establishment
NameAddressID/FEIBusiness Operations
ZheJiang Jiuzhou Pharmaceutical Co., Ltd.654682061api manufacture

Revised: 8/2015
 
Aspen Veterinary Resources