NYSTATIN suspension
Drug Labeling and Warnings
Drug Details [pdf]
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DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.
Structural formula:
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.
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CLINICAL PHARMACOLOGY
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 vitroon repeated subculture in increasing levelso f 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.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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PRECAUTIONS
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.
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ADVERSE REACTIONS
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.
- OVERDOSAGE
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DOSAGE AND ADMINISTRATION
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.
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HOW SUPPLIED
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
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SHAKE WELL BEFORE USE
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
- Nystatin 16 oz (473 mL)
- Nystatin 60 mL Bottle and Carton Labels
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INGREDIENTS AND APPEARANCE
NYSTATIN
nystatin suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 81033-015(NDC:85742-013) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 U in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCROSE (UNII: C151H8M554) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color yellow Score Shape Size Flavor CHERRY (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 81033-015-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2026 2 NDC: 81033-015-60 1 in 1 CARTON 08/31/2026 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062832 08/14/2020 Labeler - Kesin Pharma Corporation (117447816)
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