Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 11788-031-00
  • 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 21, 2017

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

  • Active ingredient (in each softgel)

    Simethicone 125 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 4 softgels in 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 15º - 30ºC
  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide and white edible ink

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE SOFTGELS, USP 125 mg

    Quantity : 28000 Capsules
    NDC. No : 11788-031-00

    WARNING:

    KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

    simethicone 125mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULE (oval) Size10mm
    FlavorImprint Code AP31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11788-031-001 in 1 BOX09/01/2017
    128000 in 1 BAG; 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(11788-031) , analysis(11788-031)