Label: SIMETHICONE 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 October 20, 2020

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  • ACTIVE INGREDIENT

    Simethicone 250mg

  • PURPOSE

    Anti-gas

  • INACTIVE INGREDIENT

    D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol

  • DOSAGE & ADMINISTRATION

    • swallow one or two softgels as symptoms occur
    • do not exceed 2 softgels per 24 hours except under the advice and super vision of a physician

  • INDICATIONS & USAGE

    relieves bloating, pressure or fullness commonly referred to as gas

  • WARNINGS

    Stop use and ask a doctor if condition persists.

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

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20-25°C (68-77ºF).
    • protect from heat, humidity and light.
    • TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING
  • PRINCIPAL DISPLAY PANEL

    788

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-788
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 788
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-788-0660 in 1 BOTTLE; Type 0: Not a Combination Product10/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/20/2020
    Labeler - H-E-B (007924756)
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