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NYSTATIN ORAL SUSPENSION 100,000UNITS/ML 16OZ 473ML

Generic: NYSTATIN

NDC:69315-0504-47

Manufacturer:Leading Pharma, LLC

Strength:100000 [USP'U]/mL

Dosage Form:SUSPENSION

Route:ORAL

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Drug Information

Identification

Generic Name

NYSTATIN

Brand Name

NYSTATIN

Labeler / Distributor

Leading Pharma, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

SUSPENSION

Route of Administration

ORAL

FDA Application Number

ANDA214346

Active Ingredients

Ingredient	Strength
NYSTATIN	100000 [USP'U]/mL

Pharmacological Class

Polyene AntifungalPolyenes [CS]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Nystatin Drug Page NDC 69315-0504-47 Lookup

Clinical Drug Information

Indications & Usage

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

Dosage & Administration

DOSAGE AND 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.

Adverse Reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch. 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.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.