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 7, 2023

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

View All Sections
  • 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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!