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

INFANTS: 2 mL (200, 000 units) four times daily (in infants and young children, use dropper to place 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 (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.

Nystatin Oral Suspension, USP, 100,000 USP Nystatin U/mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in:

2 fl oz (60 mL) bottles with 0.5 mL, 1 mL, 1.5 mL, 2 mL calibrated dropper

NDC 51672-4117-4

1 Pint (473 mL) bottles

NDC 51672-4117-9

1 Gallon (3785 mL) bottles (For repackaging only)

NDC 51672-4117-0

Storage: Store at 20°-25°C (68°-77°F) [see USP

Controlled Room Temperature]. Protect from freezing.

PHARMACIST: Dispense in a tight, light-resistant container as defined in USP.

Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110. Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, N.Y. 10532. Issued: February, 2006. FDA rev date: 07/23/07

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