Label: STOZYME- pancreatin, hemicellulase, ox bile extract, dimethicone tablet

  • NDC Code(s): 72850-0004-1
  • Packager: Chunwoo Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 4, 2019

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  • ACTIVE INGREDIENT

    Pancreatin 36.46%

    Hemicellulase 10.42%

    Ox Bile Extract 5.21%

    Dimethicone 5.21%

  • INACTIVE INGREDIENT

    Food Blue No. 1, Food Yellow No. 4, Colloidal Silicon Dioxide, Microcrystalline Cellulose, Low-Substituted Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose Phthalate, Glyceryl Monostearate, Castor Oil, Hypromellose 2910, Titanium Oxide, Polyethylene Glycol 6000,

  • PURPOSE

    Anorexia, overeating, and abdominal distention

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    Do not take if

    -you have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine contains lactose (sugar) carbohydrates.

    -you are under 5

    Ask doctor before taking if

    - you are on other medication

    - you are hypersensitive or have history of allergic response to Tartazine

    Keep the proper usage and volume

    Stop use and ask a doctor if

    - If there is no improvement in the irradiation after 2 weeks of taking the medicine

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    Treats anorexia, overeating, and abdominal distention

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    STOZYME 
    pancreatin, hemicellulase, ox bile extract, dimethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72850-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HEMICELLULASE (ASPERGILLUS NIGER) (UNII: S2MZZ5DR1O) (HEMICELLULASE (ASPERGILLUS NIGER) - UNII:S2MZZ5DR1O) HEMICELLULASE (ASPERGILLUS NIGER)10.42   in 100 
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5.21   in 100 
    PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE36.46   in 100 
    BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU) BOS TAURUS BILE5.21   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72850-0004-110 in 1 BLISTER PACK; Type 0: Not a Combination Product10/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/19/2019
    Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chunwoo Pharmaceutical Co., Ltd.688729065manufacture(72850-0004)
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