Label: MYLANTA GAS  MAXIMUM STRENGTH- dimethicone tablet, chewable 

  • NDC Code(s): 16837-861-24
  • Packager: McNeil Consumer Pharmaceuticals Co.
  • 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 03/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

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  • Purpose

    Antigas

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  • Use

    • relieves bloating, pressure, and discomfort of gas which can be caused by certain foods (such as beans, bran, and broccoli) or air swallowing
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  • Warnings

    Keep out of reach of children.

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  • Directions

    • thoroughly chew 1-2 tablets as needed after meals and at bedtime
    • do not exceed 4 tablets per day unless directed by a physician
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  • Other information

    • each tablet contains: calcium 66 mg
    • store between 20-25°C (68-77°F). Avoid high humidity.
    • do not use if carton or any blister unit is open or broken
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  • Inactive ingredients

    D&C red no. 7 calcium lake, dextrates, flavors, magnesium stearate, modified starch, silicon dioxide, tribasic calcium phosphate

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  • Questions or comments?

    call 1-800-469-5268 (toll-free) or 215-273-8755 (collect)

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  • PRINCIPAL DISPLAY PANEL

    NDC 16837-861-24

    Mylanta®
    Gas

    SIMETHICONE • ANTI-GAS

    MAXIMUM
    STRENGTH

    Fast Acting

    • Pressure
    • Bloating
    • Discomfort

    CHERRY
    Chewable Tablets

    24 TABLETS-125 mg each

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    MYLANTA GAS   MAXIMUM STRENGTH
    dimethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:16837-861
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTRATES  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    TRIBASIC CALCIUM PHOSPHATE  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 16mm
    Flavor CHERRY Imprint Code MYL;GAS;125
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16837-861-24 4 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 06/01/1996
    Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)
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