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Gas Relief Ultra Strength (Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BAG in 1 BOX (53345-003-03) > 25000 CAPSULE, LIQUID FILLED in 1 BAG Label Information

Complete Gas Relief Ultra Strength Information

  • Active ingredient (in each capsule)

    Simethicone 180 mg


  • Purpose

    Antiflatulent


  • Usesfor relief of:

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

  • Warnings

    Stop use and ask a doctor if condition persists.


  • PREGNANCY OR BREAST FEEDING

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


  • KEEP OUT OF REACH OF CHILDREN

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


  • Directions

    • swallow 1 or 2 softgels as needed after meals
    • do not exceed 2 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

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

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


  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SIMETHICONE CAPSULES,180 mg

    Quantity : 25000 Capsules
    NDC. No : 53345-003-03

    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"

    PRINCIPAL DISPLAY PANEL - Shipping Label

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF ULTRA STRENGTH 
    simethicone 180 mg capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-003
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE) DIMETHICONE 410 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color orange Score no score
    Shape CAPSULE (oval) Size 11mm
    Flavor Imprint Code PC3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53345-003-03 1 in 1 BOX
    1 25000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 04/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    Name Address ID/FEI Business Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-003) , ANALYSIS(53345-003)