Label: GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled

  • NDC Code(s): 59970-078-30
  • Packager: Navarro Discount Pharmacies,LLC
  • 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 10/12

If you are a consumer or patient please visit this version.

  • Active Ingredients (in each softgel)

    Simethicone 125mg

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  • Purpose

    Antiflatulent

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  • Uses

    For Relief of:

    • Bloating
    • Pressure
    • Fullness
    • stuffed feeling commonly referred to as gas
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  • Warnings

    Stop use and ask a doctor if

    condition persists

    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.

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  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.
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  • Other information

    • store at a controlled room temperature 15-30°C (59-86°F)
    • protect from heat and moisture
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  • Inactive ingreients

    FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59970-078
    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
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    GELATIN  
    GLYCERIN  
    WATER  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color green Score no score
    Shape OVAL Size 9mm
    Flavor Imprint Code GR
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59970-078-30 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 01/21/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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