Rx Only

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.

Structural formula:

C 47H 75NO 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 peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

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 Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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).

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 to 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.

Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 0121-0868-02:  2 fl oz (60mL) bottle with calibrated dropper

NDC 0121-0868-16:  16 fl oz (473mL) bottle

NDC 0121-0868-05:  5mL unit dose cup.  Case contains 40 unit dose cups of 5 mL (NDC 0121-0868-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC 0121-0868-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC 0121-0868-00) packaged in 10 trays of 10 unit dose cups each.

R02/22

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

60 mL

NDC 0121-0868-02

Nystatin Oral Suspension, USP

100,000 units per mL

SHAKE WELL BEFORE USING

Packaged with Calibrated Dropper

DO NOT USE IF TAMPER EVIDENT
SEAL IS BROKEN OR MISSING. 

Rx ONLY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Each mL of cherry, peppermint flavored  oral suspension contains 100,000 units Nystatin, USP and alcohol (≤ 1% v/v).

USUAL DOSAGE: For 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 the mouth and avoid feeding feeding for 5 to 10 minutes). See insert. 

WARNINGS:  Keep this and all drugs out of reach of children. In case of accidenta loverdose, seek professional assistance or contact a Poison Control Center immediately.

Keep tightly closed. Protect from light.

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature}.

AVOID FREEZING

X0868020120         R01/20

Delivers 5 mL

NDC 0121-0868-05

NYSTATIN  ORAL  SUSPENSION, USP

500,000 units/5 mL

Alcohol ≤ 1% v/v   SHAKE WELL

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.,
GREENVILLE, SC 29605

SEE INSERT

A0868051021