Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 53345-032-02
  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 250 mg

  • Purpose

    Anti-gas

  • Use

    relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if

    condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store at room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

    D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Simethicone Capsules 250 mg

    NDC 53345-032-02

    Quantity: 12 Capsules per blister

    124 Blisters per box

    IMPORTANT:

    Inspect immediately upon receipt.
    This is a bulk shipment, intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.
    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:53345-032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorpurple (clear) Scoreno score
    Shapecapsule (oval) Size13mm
    FlavorImprint Code PC31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-032-02124 in 1 BOX06/30/2016
    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 finalpart33206/30/2016
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(53345-032) , analysis(53345-032)
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