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

  • NDC Code(s): 53943-823-30
  • Packager: Discount Drug 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 December 28, 2022

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  • Active ingredient (in each softgel)

    Simethicone 125mg

  • Purpose

    Antigas

  • Use

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

    •
    store at controlled room temperature 20-25ºC (68-77ºF)
    •
    protect from light, heat, and moisture
  • Inactive ingredients

    D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    800-935-2362

  • Principal Display Panel

    Carton.JPG
  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUGMART GAS RELIEF  EXTRA STRENGTH SOFTGELS
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-823
    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 TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code SCU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-823-302 in 1 CARTON09/15/2021
    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 finalpart33209/15/2021
    Labeler - Discount Drug Mart, Inc (047741335)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Caps Romania565466997manufacture(53943-823)
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