Label: SIMETHICONE tablet, chewable

  • NDC Code(s): 54738-518-01
  • Packager: Richmond Pharmaceuticals, Inc.
  • 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 October 30, 2017

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  • Drug Facts

    .

  • Active Ingredient

    (in each chewable tablet)

    Simethicone 80 mg

  • Purpose

    Antiflatulent

  • Uses

    relieves

    • bloating
    • pressure
    • discomfort of gas which can be caused by certain foods or air swallowing
  • Warnings

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

  • Keep out of reach of children

  • Directions

    • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
    • do not exceed 6 tablets per day unless directed by a doctor
  • Other Information

    • store at room temperature 15-30 °C (59-86 °F)
    • protect from moisture
  • Inactive Ingredients

    dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

  • Package Label

    NDC:  54738-518-01

    – 100 CHEWABLE image description TABLETS

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-518
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code AP;019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-518-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/01/2011
    Labeler - Richmond Pharmaceuticals, Inc. (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(54738-518)
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