Label: SIMETHICONE 80MG- simethicone tablet, chewable

  • NDC Code(s): 77333-812-10, 77333-812-25
  • Packager: Gendose Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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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 DrugM00209/02/2022
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
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