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 1, 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.

  • 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

    PlusPHARMA

    SIMETHICONE 80 mg

    ANTI GAS

    Acts Fast to Relieve:

    •
    Bloating
    •
    Discomfort
    •
    Pressure

    Compare to the Active Ingredient in Gas-X® Chewables.

    This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Chewables.

    100 CHEWABLE TABLETS 80mg Each

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-516-00
  • INGREDIENTS AND APPEARANCE
    PLUSPHARMA 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-516(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:63187-516-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/27/2006
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-516) , RELABEL(63187-516)
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