Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 NDC 62135-813-47 – bottle of 473 mL NDC 62135-813-05 – 5 mL Unit Dose Cups NDC 62135-813-24 – 20 Unit Dose Cups of 5 mL each 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. 01/2026; PRINCIPAL DISPLAY PANEL Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-46 - 60 ml Bottle Label Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-47 - 1 Pint (473 mL) Bottle Label Nystatin Oral Suspension, USP 500,000 units/5mL - NDC 62135-813-05 – 5 mL Unit Dose Label image description image description image description
- HOW SUPPLIED 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 NDC 62135-813-47 – bottle of 473 mL NDC 62135-813-05 – 5 mL Unit Dose Cups NDC 62135-813-24 – 20 Unit Dose Cups of 5 mL each 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. 01/2026
- PRINCIPAL DISPLAY PANEL Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-46 - 60 ml Bottle Label Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-47 - 1 Pint (473 mL) Bottle Label Nystatin Oral Suspension, USP 500,000 units/5mL - NDC 62135-813-05 – 5 mL Unit Dose Label image description image description image description
Overview
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. image description
Indications & Usage
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .
Dosage & Administration
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.
Warnings & Precautions
No warnings available yet.
Contraindications
Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
Adverse Reactions
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.
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