Label: SIMETHICONE 80MG- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 17, 2022

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    SIMETHICONE 80MG

  • PURPOSE

    ANTI-GAS

  • USES

    • RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT
  • WARNINGS

    • GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    • ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
    • DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.
  • OTHER INFORMATION

    • EACH TABLET CONTAINS: CALCIUM 60MG
    • STORE AT ROOM TEMPERATURE
  • INACTIVE INGREDIENTS

    DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Simethicone_80mg_100 tablets

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 80MG 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize15mm
    FlavorImprint Code RP111
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77333-812-10100 in 1 BOX10/15/2022
    1NDC:77333-812-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00209/02/2022
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
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