Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 11788-032-12
  • Packager: AiPing 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 September 19, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Uses

    • relief of pressure, bloating, and fullness commonly referred to as gas
  • WARNINGS

    Warnings

    Keep out of reach of children

  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
  • Other information

    • store at controlled room temperature 20-25ºC (68-77ºF)
    • protect from heat and moisture

    TAMPER EVIDENT FEATURE:

    Simethicone Softgels, USP 180mg are sealed in blister packets. Use only if the individual seal is unbroken.

  • Inactive ingredients

    FD&C Yellow No. 6, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide and white edible ink

  • Questions or comments?

    Call 1-844-374-0016

  • Principle Display Panel

    Manufactured for:

    AiPing Pharmaceutical, Inc.

    Hauppauge, NY 11788

    Manufactured by:

    Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

    simethicone 180mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE (oval) Size11mm
    FlavorImprint Code AP32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11788-032-121 in 1 BOX09/01/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33209/01/2017
    Labeler - AiPing Pharmaceutical, Inc. (079674526)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-032) , analysis(11788-032)