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

  • NDC Code(s): 63868-586-30
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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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
    QUALITY CHOICE GAS RELIEF  EXTRA STRENGTH SOFTGELS
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-586
    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:63868-586-302 in 1 CARTON12/02/2020
    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 DrugM00212/02/2020
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Caps Romania565466997manufacture(63868-586)
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