Stozyme

Manufacturer: Chunwoo Pharmaceutical Co., Ltd.
Effective date: 2019-11-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:01:24

Label at a glance#

ProductStozyme

Active ingredientHEMICELLULASE (ASPERGILLUS NIGER), DIMETHICONE, PANCRELIPASE, BOS TAURUS BILE

Label structure8 sections

Indications and uses

for oral use only

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Pancreatin 36.46%

Hemicellulase 10.42%

Ox Bile Extract 5.21%

Dimethicone 5.21%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Anorexia, overeating, and abdominal distention

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNING

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

for oral use only

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

Treats anorexia, overeating, and abdominal distention

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8a	Product name	2	20200325
19041f15-771b-3d3a-88fc-f5e2d079cd6d	Product name	2	20200325
1987d950-08e4-4b70-adeb-fb67a71142ab	Product name	2	20200325
8825ddf7-1520-4680-b0ee-684e2fa73672	Product name	2	20200325
267a6f34-90b4-2f48-3063-4f505d06a7be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72850-0004-1	2024-01-30	C162847	48780-1	1030e365-4b70-111a-e063-dadaa90a10e2	96932453-80c2-4a44-e053-2a95a90a7bb6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72850-0004-1	Stozyme	10 in 1 BLISTER PACK	TABLET	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72850-0004	STOZYME (PANCREATIN, HEMICELLULASE, OX BILE EXTRACT, DIMETHICONE) TABLET [CHUNWOO PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20191105_96932453-80c2-4a44-e053-2a95a90a7bb6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Stozyme
pancreatin, hemicellulase, OX bile extract, dimethicone
HEMICELLULASE (ASPERGILLUS NIGER)
DIMETHICONE
PANCRELIPASE
PANCRELIPASE LIPASE
BOS TAURUS BILE
POLYETHYLENE GLYCOL 6000

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72850-0004	72850-0004-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HEMICELLULASE (ASPERGILLUS NIGER)	S2MZZ5DR1O	ACTIB
DIMETHICONE	92RU3N3Y1O	ACTIB
PANCRELIPASE	FQ3DRG0N5K	ACTIM
BOS TAURUS BILE	ET3651ZLOU	ACTIB
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
96932453-80c3-4a44-e053-2a95a90a7bb6			96932453-80c2-4a44-e053-2a95a90a7bb6	2019-11-04	Warnings	Exact identifier spl id: 96932453-80c3-4a44-e053-2a95a90a7bb6 spl set id: 96932453-80c2-4a44-e053-2a95a90a7bb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.