MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]

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MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]
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NDC 62372-801-50
Set ID c6db9af2-d457-477d-baa9-470ddbba5905
Category HUMAN OTC DRUG LABEL
Packager Infirst Healthcare Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each 3 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

    adipic acid , carboxymethylcellulose sodium ,D&C red 27 lake, FD&C blue 1 lake, FD &C yellow 6 lake, 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

    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 Arctic Mint & 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

    Mylanta GAS Minis 50 tablets Assorted Flavor

    Package level for 60 chewable tablets

    MYLGAF60FC MYLANTA GAS RELIEF

    Mylanta Pouch Pack Label

    Mylanta Mini Pouch Pack 3 Mini Tablets
  • INGREDIENTS AND APPEARANCE
    MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    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
    ColorPINK (LIGHT) , ORANGE, PURPLEScoreno score
    ShapeOVAL (OBLONG) Size12mm
    FlavorFRUIT (ASSORTED) Imprint Code MYLG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-801-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
    2NDC:62372-801-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
    3NDC:62372-801-033 in 1 POUCH; Type 0: Not a Combination Product10/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/21/2016
    Labeler - Infirst Healthcare Inc. (079159739)
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