Label: GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled

  • 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 November 9, 2022

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antiflatulent (Antigas)

  • 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 needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physican
  • Other information

    • store between 15º-30ºC (59º-86ºF)
    • protect from heat and moisture
  • Inactive ingredients

    FD&C red #40*, FD&C yellow #6, gelatin, glycerin, purified water, white printing ink*

    *contain one or more of these ingredients

  • Questions or comments?

    Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    COMPARE TO Phazyme® Ultra Strength active ingredient†

    Ultra Strength

    Gas Relief

    SIMETHICONE 180 mg

    Antiflatulent Antigas

    Fast relief of:

    • Gas
    • Pressure
    • Bloating
    • Discomfort

    Small, Easy to Swallow

    SOFTGEL

    †This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETS WARNINGS AND PRODUCT INFORMATION

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Package Label

    Simethicone 180 mg

    SIGNATURE CARE Ultra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-832
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code S180;05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-832-601 in 1 BOX01/31/201902/28/2025
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/31/201902/28/2025
    Labeler - Safeway, Inc. (009137209)
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