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Sulmet

Boehringer Ingelheim Vetmedica, Inc.

® (sulfamethazine) ®


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

NADA 122-271, Approved by FDA

Antibacterial

For Animal Use Only

Indications

This size Oblet is indicated for the treatment of the following diseases when caused by organisms susceptible to sulfamethazine.

Calves: Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.); Colibacillosis (Bacterial Scours) (Escherichia coli); Calf Diphtheria (Fusobacterium necrophorum)

Foals: Bacterial Pneumonia (secondary infections associated with Pasteurella spp.); Strangles (Streptococcus equi); Bacterial Enteritis (Escherichia coli)

Once-a-Day Dosage by Mouth

First Day: One Oblet for each 50 lb body weight.

Following Days: One-half Oblet for each 50 lb body weight. This dosage will provide approximately 100 mg/lb body weight the first day, and 50 mg/lb body weight on each following day.

Weight of Animal:

50 lb

100 lb

150 lb

200 lb

Dosage - First Day

1 Oblet

2 Oblets

3 Oblets

4 Oblets

Dosage - Following Days

1/2 Oblet

1 Oblet

1-1/2 Oblets

2 Oblets

Give indicated dose once daily until animal’s temperature and appearance are normal. Lubricate Oblets before dosing.

Precautions

Sulmet sulfamethazine works fast. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Excessive dosage may cause toxic reactions. Follow above dosages carefully. Fluid intake must be adequate while treating with Sulmet. For best advice in the control and treatment of disease, consult a veterinarian. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days.

Residue Warnings

Treated cattle must not be slaughtered for at least 10 days after the last dose. Exceeding five (5) consecutive doses 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 time. 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.

Do not use in horses intended for human consumption.

Restricted Drug (California) – Use Only as Directed

Store at or below 25°C (77°F).

Sulmet and Oblets are registered trademarks of Boehringer Ingelheim Vetmedica, Inc.

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

Bottle Label, 5 g, 50 Oblets – Main Panel

Bottle Label, 5 g, 50 Oblets – Side Panel

Sulmet

Sulfamethazine TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:0010-4710
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFAMETHAZINE SULFAMETHAZINE 5 g

Product Characteristics

Color Size Imprint Code Shape
TURQUOISE 35 mm SULMET;S48 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0010-4710-01 50 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA122271 2011-01-31


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