Label: GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 70677-1093-1
  • Packager: Strategic Sourcing Services LLC
  • 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 April 10, 2023

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

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

  • Questions or comments?

    Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

  • Principal Display Panel

    COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*

    ULTRA STRENGTH

    Gas Relief

    Simethicone 180 mg

    ANTIGAS

    Relieves Gas Symptoms

    Relief of:

    • Gas
    • Pressure
    • Bloating
    • Fullness

    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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by McKesson Corp.,

    via Strategic Sourcing Services LLC.

    Memphic, TN 38141

    www.fosterandthrive.com

  • Product Label

    Simsthicone 180 mg

    FOSTER & THRIVE Ultra Strength Gas Relief

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1093
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 05A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1093-11 in 1 BOX03/31/2023
    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 finalpart33203/31/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
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