Label: GAS RELIEF- simethicone 180 mg 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 March 22, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)                                         Purpose

    Simethicone 180 mg............................................................. Antigas

  • Uses

    for relief of

    ■ pressure, bloating, and fullness commonly referred to as gas

  • Warnings

    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.

  • Directions

    ■ adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

    ■ do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

  • Other information

    ■ store at controlled room temperature 20°-25°C (68°-77°F).

    ■ protect from moisture

    ■ read all product information before using.

    ■ keep this box for important information

  • Inactive ingredients

    FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL

    Compare to the Active Ingredients in
    Gas-X Ultra Strength

    Simethicone Softgels, 80 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Softgel Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone 180 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-019
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-019-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-019-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-019-022 in 1 POUCH
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/01/2009
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PVT LTD675584180manufacture(70005-019)
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