Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 53345-033-01
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
  • 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 8, 2019

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  • Active ingredient (in each capsule)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses 

    for relief of

    • pressure, bloating, and fullness commonly referred to as gas
  • 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 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
  • Inactive ingredients

    D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
    Wuhan, Hubei
    430206, China

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE CAPSULES, 125 mg

    Quantity : 25000 Capsules
    NDC. No : 53345-033-01

    IMPORTANT:
    1.Inspect immediate upon receipt.
    2.This is a bulk shipment, intended for further processing only.
    3.Protect from heat, humidity, and light. Do not refrigerate.
    4.Store at 15-30°C (59-86°F)

    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULE (OVAL) Size10mm
    FlavorImprint Code 664
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-033-011 in 1 BOX01/28/2015
    125000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/28/2015
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(53345-033) , ANALYSIS(53345-033)
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