SULMET- sulfamethazine sodium powder, for solution

Sulmet by

Drug Labeling and Warnings

Sulmet by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD, Huvepharma, Inc. - St. Louis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Front Panel

Sulmet®

(sodium sulfamethazine)
Soluble Powder

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

Antibacterial

For Animal Use Only

Net Contents: 1 lb (453.5 g)

NADA 122-272, Approved by FDA

Huvepharma®

1114163010
Rev. 12-2015

Restricted Drug (California) - Use Only as Directed.
Not for Human Use.
Sulmet is a registered trademark of Huvepharma.

Manufactured for:
Huvepharma, Inc. 525 Westpark Drive, Suite 230

Peachtree City, GA 30269 U.S.A.

Lot No. & Exp. Date

Indications

This 1lb pouch contains 100% sodium sulfamethazine. Convenient, once-a-day dosage in drinking water or as a drench.

For the control and treatment of the following diseases when casused by one or more of the following pathogenic organisms susceptible to sulfamethazine.

For the treatment of: Cattle - Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex)(Pasteurella spp.)
Colibacillosis (Bacterial Scours)(Escherichia coli)NecroticPododermatitis (Foot Rot)(Fusobacterium necrophorum)Calf Diptheria (Fusobacterium necrophorum)Acute Mettritis (Streptococcus spp.)

Beef Cattle-Acute Mastasis (Streptococcus spp.)

Swine-Porcine Colibacillosis (Bacterial Scours)(Escherichia coli)
Bacterial Pneumonia (Pasteurella spp.)

For the Control of: Chickens-Infectious Coryza (Avibacterium paragallinarum)
Coccidiosis (Eimeria tenella, Eimeria necatrix)Acute Fowl Cholera (Pasteurella multocida)Pullorum Disease (Salmonella Pullorum)

Turkeys-Coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides)

Precaution

For best advice in control and treatment of animal disease, consult a veterinarian. Have only medicated water available during the treatment, and check carefully to insure adequate drug dosage and water intake. Cattle and calves not drinking or eating must be dosed by drench or with Sulmet Oblets. For best results, treat sick animals individually.
In poultry, consult a veterinarian or poulty pathologist for diagnosis. for control of outbreaks of disease, medication should be initiaited as soon as the diagnosis is determined.Medicated cattle, swine, chickens, and turkeys must actually consume enough medicated water which provides the recommended dosages.Sulmet works fast. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Excessive dosage may cause toxic reactions. Follow dosage and administration instructions carefully. Hatchability of eggs laid during medication with sulfas, and for short periods thereafter, may be adversely affected.Treatment of all diseases should be institued early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle or swine.

Residue Warnings

Do not medicate chickens or turkeys producing eggs for human consumption. To avoid drug
residues in edible flesh withdraw medication from chickens and turkeys ten (10) days prior to slaughter for food.

Treated cattle must not be slaughtered for at least ten (10) days after the last does. Exceeding five (5) consecutive
days of treatment may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves
under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative
residues to remain beyond the withdrawal tiem. Do not use in female dairy cattle 20 months of age or older. Use of
sulfamethazine in this class of cattle may cause milk residues.

Withdraw medication from swine fifteen (15) days prior to slaughter for food. 

Administration in Drinking Water

Prepare fresh Solutions Daily

Administration in Drinking Water: Prepare a 12% stock solution by adding the contents of this package to on gallon of water.

Dosage:

Cattle, Calves and Swine: 1st day: 6 tablespoons (3 fl oz) for each 100 lb bodyweight, providing approximately 108 mg/lb (237.6 mg/kg) body weight.

2nd, 3rd, 4th days: 3 tablespoons (1 1/2 fl oz) for each 100 lb bodyweight, providing approximately 54 mg/lb (118.8 mg/kg) body weight.

Poultry: Add 2 tablespoons (1 fl oz) to each gallon, or one gallon of stock solution to 128 gallons. Following administration direction, this will provide a recommended dose of approximately 58 to 85 mg/lb/day (128 to 187 mg/kg/day) body weight in chickens and 50 to 124 mg/lb/day (110 to 273 mg/kg/day) body weight in turkeys, depending on the dosage, age class of chickens or turkeys, ambient temperature and other factors.

Administration: Cattle, Calves and Swine:In Drinking Water-Add the required dose listed above to that amount of water that will be consumed in one day; consumption should be carefully checked. Factors such as temperature, humidity and disease will cause variable fluid intade. As a generalization, the animals listed above will consume approximately 1 gallon per 100 lb body weight per day.

As a Drench-Dilute the proper dose of stock solution, and drench or administer with dose syringe. Cattle and calves not drinking must be dosed by drench or with Sulmet Oblets. For best results, pen-up animals to be treated, and treat sick animals individually.

Chickens and Turkeys: Add the required dose to the that amount of water that will be consumed in one day. Water consupmtion should be carefully checked to insure adequate intake. As a generalization, 100 turkeys will drink one gallon of water per day for each week of age; chickens will consume one-half this amount.

Infectious Coryza (in chickens): Medicate for 2 consecutive days.

Acute Fowl Cholera and Pullorum Disease (in chickens): Medicate for 6 consecutive days.

Coccidiosis (in chickens and turkeys): Medicate as listed above for 2 days, then reduce drug concentration to one-half above for 4 additional days.

Storage

Store at or below 25°C (77°F)

Pouch Label Image

INGREDIENTS AND APPEARANCE

SULMET 
sulfamethazine sodium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-6500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFAMETHAZINE SODIUM (UNII: 7Z13P9Q95C) (SULFAMETHAZINE - UNII:48U51W007F)	SULFAMETHAZINE SODIUM	453.51 g  in 453.51 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-6500-1	453.51 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA122272	10/30/2015

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc. - St. Louis		883128204	manufacture, analysis, pack, label, medicated animal feed manufacture