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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antiflatulent (Antigas)

  • Use

    • 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 care 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 physician
  • 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*

    *contains one or more of these ingredients

  • Questions or comments?

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

  • Principal Display Panel

    †Compare to the active ingredient in Phazyme® Ultra Strength

    ULTRA STRENGTH

    GAS RELIEF

    ANTIGAS SIMETHICONE 180 mg

    FAST RELIEF OF

    • Pressure
    • Bloating
    • Discomfort

    SOFTGELS

    SMALL, EASY TO SWALLOW

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

    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: Fred's Inc.

    4300 New Getwell Rd., Memphis , TN 38118

    www.fredsinc.com

  • Package Label

    Simethicone 180 mg

    FRED'S PHARMACY Ultra Strength Gas Relief

     

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-832
    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:55315-832-601 in 1 BOX09/30/201806/30/2024
    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 DrugM00209/30/201806/30/2024
    Labeler - Freds Inc (005866116)
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