GAS RELIEF (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]

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GAS RELIEF (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]
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NDC 70005-019-02, 70005-019-25, 70005-019-50
Set ID 90178439-c3fe-47d1-bebb-466371fa2adf
Category HUMAN OTC DRUG LABEL
Packager We Care Distributor Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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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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