Label: MYLANTA GAS MINIS MINT FLAVOR- simethicone tablet, chewable

  • NDC Code(s): 62372-800-50, 62372-800-60
  • Packager: Infirst Healthcare Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 17, 2019

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

  • Active ingredient (in each 3 mini -tablet dose)

    Simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses

    Relieves pressure and bloating commonly referred to as gas

  • Warnings

    Keep out of the reach of children.

  • Directions

    Adults and children 12 years and older: thoroughly chew 3-6 mini-tablets as needed.
    do not exceed 12 mini-tablets in 24 hours except under the advice and supervision of a physician.
  • Other information

    each dose contains: calcium 75 mg
    protect from heat and moisture
    store at 20-25° C (68-77° F)
  • Inactive ingredients

    carboxymethylcellulose sodium, flavors, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, silica, sucralose, sucrose, tricalcium phosphate

  • Questions or comments?

    call 1-844-695-6624 toll free (English & Spanish)

  • Principal Display Panel

    FREE 20% MORE

    CONVENIENT POCKET PACK

    FAST RELIEF ON THE GO

    Mylanta®

    GAS Minis

    Fast relief of the bloating , pressure, and discomfort of gas
    Extra Strength, with the #1 selling medicine for gas relief
    Great tasting ,chewable mini-tablets in an on-the-go pack
    Also available in great tasting Assorted Fruit & Cherry

    TAMPER EVIDENT: DO NOT USE MYLANTA GAS MINI-TABLETS IF THE BREAKAWAY BAND ON TOP OF CONTAINER IS BROKEN OR MISSING.

     

    Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co.

    Patent pending

    infirst+

    HEALTHCARE

    Manufactured for:

    Infirst Healthcare Inc.

    Westport, CT 06880

    ©2016 Infirst Healthcare Inc.

    Mylanta.com

    KEEP OUTER PACKAGING FOR COMPLETE LABELING

    Package Label for 50 Chewable Tablets

    Mylanta Gas Minis Mint Flavor 50 tablets

    Package Label for 60 Chewable Tablets

    Mylanta GAS Minis 60 Chewable Mini Tablets
  • INGREDIENTS AND APPEARANCE
    MYLANTA GAS MINIS MINT FLAVOR 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-800
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    ISOMALT (UNII: S870P55O2W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL (OBLONG) Size12mm
    FlavorMINT (ARCTIC) Imprint Code MYLG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-800-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
    2NDC:62372-800-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/21/2016
    Labeler - Infirst Healthcare Inc. (079159739)