Rx only

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.

Structural formula:

C 47H 75NO 17     MW 926.13

Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

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

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General).

Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (See CLINICAL PHARMACOLOGY, Pharmacokinetics).

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 to 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 Units per mL, is available in a cherry flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 17856-1045-01 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML CUP 72 ct UD
NDC 17856-1045-02 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML CUP 1ct UD
NDC 17856-1045-03 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML SYRINGE 48 ct UD
NDC 17856-1045-04 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML SYRINGE 1ct UD
NDC 17856-1045-05 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML ENFIT SYRINGE 48 ct UD
NDC 17856-1045-06 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML ENFIT SYRINGE 1 ct UD
NDC 17856-1045-07 NYSTATIN ORAL SUSP 100,000 UNITS/ML - 1 ML ENFIT SYRINGE 120 ct UD
NDC 17856-1045-08 NYSTATIN ORAL SUSP 100,000 UNITS/ML - 1 ML ENFIT SYRINGE 1ct UD
NDC 17856-1045-09 NYSTATIN ORAL SUSP 100,000 UNITS/1ML - 5 ML ENFIT SYRINGE 1ct UD OVERWRAP

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179