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

    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 symptoms occur
    • do not exceed two softgels per  24  hours except under the advice and supervision of a physician
  • Other information

    • store between 15-30°C (59-86°F)
    • protect from heat and moisture
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • 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

    SOFTGELS

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

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY

    BETTER LIBING 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:21130-073
    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 RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-073-6060 in 1 CARTON09/30/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33209/30/2020
    Labeler - Safeway, Inc. (009137209)
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