GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]

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GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]
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NDC 17714-019-01
Set ID 531b9850-c93e-4a0c-bd1c-7da33d752d80
Category HUMAN OTC DRUG LABEL
Packager Advance Pharmaceutical Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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  • Drug Facts

  • Active Ingredient

    (in each chewable tablet)

    Simethicone 80 mg

  • Purpose

    Antiflatulent

  • Uses

    relieves

    • bloating
    • pressure
    • discomfort of gas which can be caused by certain foods or air swallowing
  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

  • Directions

    • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
    • do not exceed 6 tablets per day unless directed by a physician
  • Other Information

    • store at room temperature 15-30 °C (59-86 °F)
    • protect from moisture
  • Inactive Ingredients

    dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

  • Package Label

    DC: 17714-019-01  – 100 CHEWABLE TABLETS

    Untitled

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code AP;019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-019-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/04/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/04/1999
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-019)
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