Label: MAXIMUM STRENGTH GAS RELIEF SOFTGEL- simethicone capsule, liquid filled

  • NDC Code(s): 51316-813-06, 51316-813-36
  • Packager: CVS PHARMACY, 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 July 27, 2023

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

View All Sections
  • Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Uses

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

  • Warnings

    Stop use and ask a doctor if condition persists.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • Swallow one or two softgels as symptoms occur
    • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from heat, humidity and light

  • Inactive ingredients

    D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water

  • Questions or comments?

    1-888-577-8033 Monday-Friday 8am-4pm EST

  • SPL UNCLASSIFIED SECTION

    *Compare to the active ingredient in Maximum Strength Phazyme®

    Relieves:
       Bloating
       Pressure
       Fullness

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

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

    Product of UAE
    Packaged and Quality Assured in the USA

    DISTRIBUTED BY: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy
    CVS.com 1-800-SHOP CVS

  • Packaging

    CVS-813

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH GAS RELIEF SOFTGEL 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-813
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 813
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-813-362 in 1 CARTON11/01/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51316-813-061 in 1 CARTON11/01/2022
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/01/2022
    Labeler - CVS PHARMACY, INC (062312574)
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!