Nystatin Oral Suspension

Rx Only

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.

Structural formula:

nystatin chemical structure

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 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 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 Xttrium Laboratories, Inc. at 1-800-587-3721 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: 4-6 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 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)

Rx Only
Product No.: 4026
Manufactured By:
Xttrium Laboratories, Inc.
1200 E. Business Center Dr.
Mount Prospect, IL 60056
402616BTLLBL
REV. 09-25

NDC 0116-4026-16

NYSTATIN ORAL SUSPENSION, USP

(100,000 units per mL)

Each mL contains: 100,000 units Nystatin, USP with the following 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, methyl paraben, 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.
Fruit Flavored
SHAKE WELL BEFORE USING
Rx Only
NET: 1 Pint (473 mL)

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 mouth and avoid feeding for 5 to 10 minutes).
USUAL DOSAGE: For Children and Adults: See package insert.
WARNINGS: Keep this and all drugs out of the reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
AVOID FREEZING
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by:
Xttrium Laboratories, Inc.
1200 E. Business Center Dr.
Mount Prospect, IL 60056
402616BTLLBL REV. 09-25

16 oz bottle label

UNIT DOSE

Delivers 5 mL
NDC 0116-4026-05
NYSTATIN
ORAL SUSPENSION, USP
500,000 units / 5 mL
Alcohol ≤ 1% v/v SHAKE WELL

Institutional Use Only

Rx Only

Xttrium Laboratories, Inc.

Mount Prospect, IL

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