Label: MYTAB FOR GAS - dimethicone tablet, chewable

  • NDC Code(s): 0603-0210-21
  • Packager: Qualitest Pharmaceuticals
  • 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 11/12

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  • Drug Facts

    .

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  • Active Ingredient

    (in each chewable tablet)

    Simethicone 80 mg

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  • Purpose

    Antiflatulent

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  • Uses

    relieves

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

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • 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
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  • Other Information

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

    dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

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  • 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.

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  • Package Label

    03c6cf11-figure-01

    MY TAB for GAS, SIMETHICONE 80 mg

    ANTIFLATULENT

    NDC: 0603-0210-21 – 100 CHEWABLE TABLETS

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  • INGREDIENTS AND APPEARANCE
    MYTAB FOR GAS 
    simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-0210
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE  
    SUCROSE  
    MALTODEXTRIN  
    PEPPERMINT  
    SORBITOL  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 13mm
    Flavor PEPPERMINT Imprint Code AP;019
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0210-21 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 03/12/1999
    Labeler - Qualitest Pharmaceuticals (011103059)
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