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

  • NDC Code(s): 49035-487-02, 49035-487-15, 49035-487-72
  • Packager: EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART 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 January 20, 2023

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    • for the relief of pressure, bloating, and fullness commonly referred to as gas
  • Warnings

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 4 softgels in 24 hours unless directed by a doctor
  • Other information

    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • protect from light, heat, and moisture
  • Inactive ingredients

    D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-888-287-1915

  • Principal Display Panel

    Compare to Gas-X® Extra Strength Active Ingredient**

    Extra Strength

    Gas Relief

    Simethicone 125 mg Antigas

    Fast Relief of:

    • Pressure
    • Bloating
    • Discomfort

    Small, easy to swallow

    SOFTGELS

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    **This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.

    DISTRIBUTED BY:

    Walmart Inc.,

    Bentonville, AR 72716

  • Product Label

    Simethicone 125 mg

    EQUATE Extra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO;SCU;L125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-487-0220 in 1 CARTON03/31/201603/31/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-487-15150 in 1 CARTON03/31/201603/31/2025
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49035-487-7272 in 1 CARTON03/31/201603/31/2025
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/201603/31/2025
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)
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