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

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 4, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!