Label: SIMETHICONE- dimethicone capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 0536-3604-08
  • Packager: Rugby Laboratories, Inc.
  • 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 03/14

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

  • Active ingredient (in each softgel)

    Simethicone 180 mg

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  • Purpose

    Antiflatulent (Antigas)

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  • Uses

    • relieves bloating, pressure or fullness 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 professional before use.

    Keep out of reach of children.

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  • Directions

    • swallow one or two softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
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  • Other information

    • store at 15°-30°C (59°-86°F)
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  • Inactive ingredients

    edible ink, FD&C yellow #6, gelatin, glycerin, purified water

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  • Questions or comments?

    1-800-645-2158

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  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN ULTRA STRENGTH PHAZYME®*

    Simethicone 180 mg

    ANTIFLATULENT

    Relieves Symptoms of Gas

    SOFTGELS

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

    *Rugby Laboratories is not affiliated with the owner of the trademark Ultra Strength Phazyme®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

    www.rugbylaboratories.com

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  • PRODUCT LABEL

    Simethicone 180 mg

    Rugby Simethicone 180 mg Softgel

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  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-3604
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    WATER  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code S180
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3604-08 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 05/09/2012
    Labeler - Rugby Laboratories, Inc. (191427277)
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