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Pill Identifier Information of Simethicone 125 MG Oral Capsule

Drug Information

Simethicone 125 MG Oral Capsule

Imprint: PC2
Shape: C48336
Color: C48329
Ingredients: Simethicone
Size: 9.00
Score: 1
Rxtty: SCD
Author: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Inactive Ingredients: SILICON DIOXIDE / FD&C BLUE NO. 1 / FD&C RED NO. 40 / D&C YELLOW NO. 10 / GELATIN / GLYCERIN / PEPPERMINT OIL / TITANIUM DIOXIDE / WATER>

Complete Information

  • Active ingredient (in each capsule)

    Simethicone 125 mg

  • Purpose

    Antiflatulent

  • Usesfor relief of:

    • bloating
    • pressure
    • fullness
    • stuffed feeling commonly referred to as gas
  • Warnings

    Stop use and ask a doctorifcondition persists.

    If pregnant or breast-feeding,ask a health care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults:swallow with water 1 or 2 softgels as needed after meals or at bedtime
    • do not exceed 4 softgels per day unless directed by doctor
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • protect from heat and moisture
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

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

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

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE CAPSULES, 125 mg

    Quantity : 25000 Capsules
    NDC. No : 53345-009-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULE (OVAL) Size9mm
    FlavorImprint Code PC2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-009-011 in 1 BOX04/15/2013
    125000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00204/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287manufacture(53345-009)
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