STOZYME- pancreatin, hemicellulase, ox bile extract, dimethicone tablet 
Chunwoo Pharmaceutical Co., Ltd.

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.

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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

label

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)

Revised: 11/2019
Document Id: 96932453-80c3-4a44-e053-2a95a90a7bb6
Set id: 96932453-80c2-4a44-e053-2a95a90a7bb6
Version: 1
Effective Time: 20191104
 
Chunwoo Pharmaceutical Co., Ltd.