Label: NYSTATIN suspension

  • NDC Code(s): 0121-0810-02, 0121-0810-16, 0121-4810-00, 0121-4810-05, view more
    0121-4810-40, 0121-4810-50
  • Packager: Pharmaceutical Associates, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 26, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    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 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.

  • CLINICAL PHARMACOLOGY

    Pharmacokinetics

    Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

    Microbiology

    Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

  • INDICATIONS AND USAGE

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

  • 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 Category C

    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.

  • ADVERSE REACTIONS

    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.

  • 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).

  • 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 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.

  • HOW SUPPLIED

    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 0121-0810-02:  2 fl oz (60mL) bottle with calibrated dropper

    NDC 0121-0810-16:  16 fl oz (473mL) bottle

    NDC 0121-4810-05:  5mL unit dose cup

    NDC 0121-4810-40:  Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in 
                                      4 trays of 10 unit dose cups each.

    Storage

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

  • SPL UNCLASSIFIED SECTION

    R10/16

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

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    60 mL

    NDC 0121-0810-02

    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 andyoung 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 accidental overdose, seek professional assistance orcontact 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

    R04/17

    X01810020417

    60 mL bottle label

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    Delivers 5 mL

    NDC 0121-4810-05

    N YSTATIN
    O RAL
    S USPENSION, USP

    500,000 units / 5 mL

    Alcohol ≤ 1% v/v   SHAKE WELL

    Rx ONLY

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.,
    GREENVILLE, SC 29605

    SEE INSERT

    A48100500

    5 mL unit dose cup label

  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0121-0810
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Product Characteristics
    Coloryellow (Light - Creamy) Score    
    ShapeSize
    FlavorCHERRY (w/Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0810-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/01/2016
    2NDC:0121-0810-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20362102/01/2016
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0121-4810
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Product Characteristics
    Coloryellow (Light - Creamy) Score    
    ShapeSize
    FlavorCHERRY (w/Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-4810-404 in 1 CASE02/01/2016
    110 in 1 TRAY
    1NDC:0121-4810-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-4810-0010 in 1 CASE02/01/2016
    210 in 1 TRAY
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:0121-4810-505 in 1 CASE06/26/2020
    310 in 1 PACKAGE
    35 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20362102/01/2016
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0810, 0121-4810)