Label: SIMETHICONE 250MG capsule, liquid filled

  • 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 May 28, 2023

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  • ACTIVE INGREDIENT

    Simethicone 180mg

  • PURPOSE

    relieves bloating, pressure, fullness, commonly referred to as gas

  • WARNINGS

    stop use and ask a doctor if condition persists

    if pregnant or breast-feedingm ask a health professional before use

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    ▪ swallow one or two softgels as needed after a meal

    ▪ do not exceed two softgels per day except under the advice and supervision of a physician

  • INDICATIONS & USAGE

    Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

  • INACTIVE INGREDIENT

    FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

  • PRINCIPAL DISPLAY PANEL

    Display Panel

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 250MG 
    simethicone 250mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73629-006-12120 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00212/01/2022
    Labeler - AMZ789 LLC (117410213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-006)
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