Nystatin (Nystatin) - Indications and Dosage

INDICATIONS AND USAGE

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

DOSAGE AND ADMINISTRATION

INFANTS: 2 mL (approximately 1/2 teaspoon)(200,000 units) four times daily 1 mL (approximately 1/4/ teaspoon) (one-half of dose) in each side of mouth and avoid feeding for 5 to 10 minutes.
NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

CHILDREN AND ADULTS: 4 - 6 mL (approximately 1 teaspoon)(400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

HOW SUPPLIED

Nystatin Oral Suspension, USP (100,000 USP Nystatin Units per mL) is available as a mint-flavored, light yellow, ready-to-use suspension in the following sizes:

NDC 0168-0037-60       60 mL bottle (with a calibrated dosing cup)
NDC 0168-0037-61       60 mL bottle (with a calibrated dropper)
NDC 0168-0037-74       1 Pint bottle

Shake well before using. Wash cup before and after each use.
Before dispensing, replace cap with safety cap dropper.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
[see USP Controlled Room Temperature].

WARNING: Keep out of reach of children.

This product sealed for your protection. If the seal is missing or broken return to place of purchase.

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NY 11747

I237B/IF237D
R11/05
#276