Label: SIMETHICONE 80MG- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2024

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

View All Sections
  • 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

  • Generic Section

    Distributed by:

    GenDose Pharmaceuticals

    Huntersville, NC 28078

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L58749200924

  • Principal Display Panel

    Simethicone 80mg

    Chewable Tablets

    10 Chewable Tablets

    Bag Label
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 80MG 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2606(NDC:77333-812)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE, UNSPECIFIED80 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DEXTROSE, UNSPECIFIED FORM (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:55154-2606-010 in 1 BAG10/01/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00210/01/2024
    Labeler - Cardinal Health 107, LLC (118546603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675REPACK(55154-2606)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!