Get your patient on Nystatin - Nystatin suspension (Nystatin)

Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .

Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).

Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).

NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.

Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.

Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

Nystatin, USP is obtained from Streptomyces noursei . It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety.

Its structural formula is:

C ₄₇ H ₇₅ NO ₁₇ M.W .926 .13

Nystatin Oral Suspension, USP, is a cherry-flavored, ready-to-use suspension containing 100,000 units of Nystatin, USP per mL. Nystatin, USP contains the following inactive ingredients: artificial (wild) cherry flavor, D&C Yellow 10, edetate calcium disodium, hydrochloric acid, methylparaben, polysorbate 80, propylparaben, purified bentonite, purified water, sodium hydroxide and sucrose.

Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

Nystatin Oral Suspension, USP is a bright yellow color suspension with cherry flavor containing 100,000 units of nystatin per mL, supplied as follows:

NDC 62135-813-46 – bottle of 60 mL with dropper

NDC 62135-813-47 – bottle of 473 mL

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F).

DO NOT FREEZE

Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920

L71884

Rev. 03/2026