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Drug Catalog - Product Detail

NYSTATIN ORAL SUSPENSION SUSP 100MU/ML 473ML

NDC Mfr Size Str Form
60432-0537-16 MORTON GROVE PHARMACEUTICALS 473 100000UNIT/ML SUSPENSION
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Description
DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow #10, FD&C red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment. nystatin-01
How Supplied
HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension. 60 mL bottles was a calibrated dropper and 1 Pint (473 mL) bottles (60432-537-16) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
Indications & Usage
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Dosage and Administration
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: 4–6 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.