Nystatin Oral Suspension
Nystatin · Suspension · Oral
Uses
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 .
Contraindications
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
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 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. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION .
Side effects
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 Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy
Pregnancy Teratogenic Effects 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.
Pediatric use
Pediatric Use See DOSAGE AND ADMINISTRATION .
Overdosage
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (See CLINICAL PHARMACOLOGY, Pharmacokinetics ).
Description
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: C 47 H 75 NO 17 MW 926.13 Nystatin Oral Suspension USP, 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 chemical structure
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 bottle was a calibrated dropper and 1 Pint (473 mL) bottles (0116-4026-16) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
Storage
Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
Label text from the FDA structured product label by Xttrium Laboratories, Inc. (revised Feb 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Nystatin in 1 product
Nystatin Oral Suspension NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0116-4026 | Nystatin 100000 [USP'U]/mL Suspension | Xttrium Laboratories, Inc. | ANDA |
Frequently asked questions
What is Nystatin Oral Suspension used for?
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
What are the side effects of Nystatin Oral Suspension?
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:… See the full label for the complete list.
Who makes Nystatin Oral Suspension?
Nystatin Oral Suspension is listed by 1 labeler in the FDA NDC directory, including Xttrium Laboratories, Inc..