Stozyme: Package Insert and Label Information

STOZYME- hemicellulase (aspergillus niger), dimethicone, pancrelipase and bos taurus bile 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.

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

STOZYME pancreatin, hemicellulase, ox bile extract, dimethicone tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72850-0004 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEMICELLULASE (ASPERGILLUS NIGER) (HEMICELLULASE (ASPERGILLUS NIGER)) HEMICELLULASE (ASPERGILLUS NIGER) 10.42 in 100 DIMETHICONE (DIMETHICONE) DIMETHICONE 5.21 in 100 PANCRELIPASE (PANCRELIPASE LIPASE) PANCRELIPASE LIPASE 36.46 in 100 BOS TAURUS BILE (BOS TAURUS BILE) BOS TAURUS BILE 5.21 in 100

Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 6000

Product Characteristics Color green Score no score Shape OVAL Size 15mm Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72850-0004-1 10 TABLET in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/19/2019

Labeler — Chunwoo Pharmaceutical Co., Ltd. (688729065)

Registrant — Chunwoo Pharmaceutical Co., Ltd. (688729065)

Establishment
Name	Address	ID/FEI	Operations
Chunwoo Pharmaceutical Co., Ltd.		688729065	manufacture (72850-0004)

Revised: 11/2019 Chunwoo Pharmaceutical Co., Ltd.