NYSTATIN ORAL SUSPENSION, USP Rx only

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

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Nystatin Oral Suspension, USP 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.

Pharmacokinetics
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Microbiology
Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

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.

General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy
Teratogenic Effects Category C
Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
Pediatric Use
See DOSAGE AND ADMINISTRATION.

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 81033-015-05: 5 mL unit-dose cup
NDC 81033-015-01: Case containing 100 unit-dose cups of 5 mL each
NDC 81033-015-54: Carton containing 50 unit-dose cups of 5 mL each
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: 11/2025
PI-015-V01

Kesin Pharma Lgog

NDC: 81033-015-54

Nystatin Oral Suspension, USP

500,000 units per 5 mL

Delivers 5 mL

50 x 5 mL

Nystatin Carton of 50 Label

NDC: 81033-015-01

Nystatin Oral Suspension, USP

500,000 units per 5 mL

Delivers 5 mL

Case = 100 UD Cups (Do Not Break Case)

Nystatin Case of 100 Label