NYSTATIN - Kesin Pharma Corporation

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.
Structural formula:

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Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: cherry flavor, dibasic sodium phosphate heptahydrate, disodium edetate, glycerin, methylparaben, monobasic sodium phosphate monohydrate, peppermint oil, propylparaben, sodium benzoate, sodium hexametaphosphate, 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 Kesin Pharma at 1-833-537-4679 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 as a cherry-mint flavored, yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 81033-015-60: 60 mL bottle with a 1 mL calibrated dropper

NDC 81033-015-16: 16 oz (473 mL) bottle

Rx Only

SHAKE WELL BEFORE USE

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

AVOID FREEZING

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

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revised: 12/2025

PI-015B-V01

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Rx Only

NDC 81033- 015-16

Nystatin Oral Suspension, USP

SHAKE WELL BEFORE USING

Nystatin 16 oz (473 mL) Bottle Label

Rx Only

NDC 81033- 015-60

Nystatin Oral Suspension, USP

SHAKE WELL BEFORE USING

Nystatin 60 mL Bottle Label

Rx Only

NDC 81033- 015-60

Nystatin Oral Suspension, USP

SHAKE WELL BEFORE USING
(Includes safe cap dropper)

Nystatin 60 mL Bottle Carton Label