MYTAB FOR GAS (SIMETHICONE) TABLET, CHEWABLE [REMEDYREPACK INC.]

MYTAB FOR GAS (SIMETHICONE) TABLET, CHEWABLE [REMEDYREPACK INC.]
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NDC 70518-0498-0
Set ID 04078b83-4483-4be9-8497-c9339f063290
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number PART332
  • 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, peppermint flavor, sorbitol, stearic acid

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

    Distributed by: Qualitest Pharmaceuticals, Inc.

  • PRINCIPAL DISPLAY PANEL

    DRUG: MYTAB For GAS

    GENERIC: Simethicone

    DOSAGE: TABLET, CHEWABLE

    ADMINSTRATION: ORAL

    NDC: 70518-0498-0

    COLOR: white

    FLAVOR: PEPPERMINT

    SHAPE: ROUND

    SCORE: No score

    SIZE: 13 mm

    IMPRINT: AP;019

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • DIMETHICONE 80mg in 1

    INACTIVE INGREDIENT(S):

    • DEXTROSE
    • PEPPERMINT
    • SORBITOL
    • MALTODEXTRIN
    • STEARIC ACID
    • SUCROSE

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    MYTAB FOR GAS 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0498(NDC:0603-0210)
    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)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    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:70518-0498-030 in 1 BLISTER PACK; Type 0: Not a Combination Product11/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/15/2017
    Labeler - REMEDYREPACK INC. (829572556)

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