Label: KROGER EXTRA STRENGTH- simethicone antigas capsule, liquid filled

  • 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 August 23, 2023

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

  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for relief of:

    pressure, bloating and fullness commonly referred to as gas
  • Warnings

    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 except under the advice and supervision of a physician.
  • Other information

    store at room temperature
    protect from light, heat and moisture.
  • Inactive ingredients

    D&C Yellow No. 10, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide.

    Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    NDC 30142-330-30

    COMPARE TO the active ingredient GAS-X® EXTRA STRENGTH SOFTGELS *See back panel

    Extra Strength

    Gas Relief

    Simethicone/125 mg

    ANTI-GAS

    FAST RELIEF OF:

    Gas
    Pressure
    Bloating
    Discomfort

    Small, Easy to Swallow

    30 SOFTGELS

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING.

    This product offers, effective relief of pressure and bloating that antacid can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

    *Gas-X® Softgels is registered trademark of GSK Consumer Healthcare, Inc. Warren, NJ 07059. GSK Consumer Healthcare, Inc. is not affiliated with The Kroger Co. or this product.

    DO NOT USE IF ANY INDIVIDUAL BLISTERS UNIT IS BROKEN OR OPEN.

    DISTRIBUTED BY:

    THE KROGER CO.

    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    800-632-6900

    www.kroger.com

    Kroger Extra Strength Simethicone Softgels
  • INGREDIENTS AND APPEARANCE
    KROGER EXTRA STRENGTH 
    simethicone antigas capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-330
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code RP113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-330-302 in 1 CARTON03/31/2020
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/31/2020
    Labeler - KROGER COMPANY (006999528)