Label: SIMETHICONE capsule, liquid filled

  • NDC Code(s): 53345-036-01
  • 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 July 25, 2016

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  • Active ingredient (in each capsule)

    Simethicone 180 mg

  • Purpose

    Anti-gas

  • Uses

    • relieves bloating, pressure or fullness commonly referred to as gas
  • WARNINGS

    Warnings

    Stop use and ask a doctorif condition persists

    Keep out of reach of children. 

  • Directions

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

    • store at room temperature 59º - 86ºF (15º - 30ºC)
  • Inactive ingredients

    FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE CAPSULES, 180 mg

    Quantity : 25000 Capsules
    NDC. No : 53345-036-01

    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

    Simethicone 180mg

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-036
    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)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oval) Size10mm
    FlavorImprint Code 667
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-036-011 in 1 BOX07/25/2016
    125000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33207/25/2016
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(53345-036) , analysis(53345-036)
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