Label: PLUSPHARMA- 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 January 11, 2021

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  • Active ingredient (in each tablet)

    Simethicone 80 mg, USP


  • Purpose

    Anti-Gas


  • Uses

    Relieves bloating and pressure commonly referred to as gas.


  • Warnings


    If pregnant or breast-feeding, ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    Keep this and all drugs out of the reach of children.

  • Directions

    • Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
    • Do not exceed 6 tablets per day except under the advice and supervision of a physician.
  • Other Information

    • Store at room temperature.
    • Avoid high humidity.
    • Do not use if imprinted safety seal under cap is broken or missing.
  • Inactive ingredients

    Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.


  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.


  • Principal Display Panel

    pdp

  • INGREDIENTS AND APPEARANCE
    PLUSPHARMA 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-643(NDC:51645-860)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Round Flat Faced Beveled Edge) Size13mm
    FlavorSPEARMINT (Natural and Artificial) Imprint Code GPI;LB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66267-643-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
    2NDC:66267-643-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
    3NDC:66267-643-022 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
    4NDC:66267-643-98360 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/27/2006
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(66267-643)
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