Label: MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, gelatin coated

  • NDC Code(s): 68210-4165-7
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Use

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

    Stop use and ask a doctor if

    condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

    D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol sorbitan, titanium dioxide

  • Questions or Comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    VALUMEDS MAXIMUM STRENGTH GAS RELIEF

    SIMETHICONE 250 mg/  Anti-gas

    Compare to the active ingredient in PHAZYME® Maximum Strength*

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

    70 SOFTGELS

    image description

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULE (oval) Size12mm
    FlavorImprint Code 250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4165-770 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00206/23/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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