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

  • NDC Code(s): 49035-530-20
  • Packager: EQUATE (Walmart Stores, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Active ingredient (in each softgel)

    Simethicone 180 mg

    Close
  • Purpose

    Antiflatulent (Antigas)

    Close
  • Use

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

    Stop using this product 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Close
  • 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
    Close
  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    Close
  • Inactive ingredients

    edibile ink, FD&C yellow # 6, gelatin, glycerin and purified water

    Close
  • Questions or comments?

    1-888-287-1915

    Close
  • Principal Display Panel

    Compare to Ultra Strength Phazyme® Active Ingredient*

    Ultra Strength

    Gas Relief

    Anti-Gas/Simethicone

    Relief of:

    • Gas discomfort
    • Pressure
    • Bloating

    180 mg LIQUID-FILLED SOFTGELS

    Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716  ©Wal-Mart Stores, Inc. Product of USA

    *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    Close
  • Package Label

    Simethicone 180 mg

    Equate Simethicone 180 mg Ultra Strength Gas Relief Softgels

     

    Close
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-530
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    WATER  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code S180
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-530-20 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 01/15/2013
    Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
    Registrant - P and L Development of New York Corporation (800014821)
    Close