Label: SIMETHICONE CERTIFIED PLUS- simethicone gel

  • NDC Code(s): 17714-076-18
  • Packager: Advance Pharmaceutical 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 November 11, 2021

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  • Active Ingredient

    Simethicone 180 mg

  • Purpose

    Antiflatulent

  • Uses

    relieves

    • bloating
    • pressure
    • fullness commonly referred to as gas
  • Warnings

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

  • Keep out of reach of children

  • Directions

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

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

    FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol

  • Questions or Comments

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

    Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

  • Package Label

    Sime

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE  CERTIFIED PLUS
    simethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-076
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScore    
    ShapeOVALSize3mm
    FlavorImprint Code PC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-076-18180 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/11/2021
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-076)
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