Label: CVS PHARMACY GAS RELIEF- 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 September 12, 2023

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Antigas

  • Uses

    relieves:

    •
    bloating & discomfort
    •
    gas distress
  • Warnings

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

  • Directions

    •
    adults: chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow tablets whole
    •
    do not exceed 6 tablets in 24 hours period except under the advice and supervision of a physician.
  • Other information

    •
    each tablet contains: calcium 60 mg
    •
    store at room temperature
  • Inactive ingredients

    dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC 51316-111-00

    Gas Relief

    Simethicone 80 mg / Antigas

    For Fast Relief of Gas Distress Bloating & Discomfort

    Mint Flavor

    Naturally and Artificially Flavored

    100 CHEWABLE TABLETS

    Distributed by

    CVS Simethicone 100 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  GAS RELIEF
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code RP111
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-111-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/06/2021
    Labeler - CVS (062312574)
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