Label: NYSTATIN suspension

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), artificial peppermint flavor, 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 Pharmaceutical Associates, Inc. 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, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 63739-160-70: 5 mL Unit Dose Cup

NDC 63739-160-10: Case of 100, 5 mL Unit Dose Cups.

Distributed By:
McKesson Corporation
dba SKY Packaging
Memphis, TN 38141

Manufactured By:
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Iss 02/2022

Delivers 5 mL

NDC 63739-160-70

NYSTATIN
ORAL SUSPENSION, USP

500,000 units / 5 mL

Alcohol ≤ 1% v/v

SHAKE WELL

FOR INSTITUTIONAL USE ONLY
Rx ONLY

Dist By: SKY Packaging
Memphis, TN 38141

SEE INSERT

A0868C050222