Label: MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 63868-975-06
  • Packager: Chain Drug Marketing Association, 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 July 25, 2023

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  • Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

    • relieves bloating, pressure or fullness commonly referred to as gas
  • Warnings

    Stop use and ask a doctor if condition persists

    If pregnant or breast-feeding, ask a health professional before use.

    Keep ​out of reach of children.

  • Directions

    • Swallow one or two softgels as symptoms occur
    • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from heat, humidity and light
  • Inactive ingredients

    D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, peppermint oil, purified water

  • Questions or comments?

    1-888-577-8033

  • SPL UNCLASSIFIED SECTION

    QUALITY CHOICE

    *Compare to the active Ingredient in Maximum Strength Phazyme®

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

    *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of PHAZYME®.

    Product of UAE

    Packaged and Qualify Assured in the USA

    REV.01-092022

    QC 100% SATISFACTION GUARANTEED

    Distributed by CDMA, Inc.
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

  • Packaging

    MSGasRelf1

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-975
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVAL (oblong) Size12mm
    FlavorImprint Code 813
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-975-061 in 1 CARTON03/28/2023
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/28/2023
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
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