MESIMA- phellinus linteus mycelium capsule

Mesima by

Drug Labeling and Warnings

Mesima by is a Otc medication manufactured, distributed, or labeled by Yein Trading & Global Co., Ltd, Han Kook Sin Yak Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

phellinus linteus mycelium

INACTIVE INGREDIENT

lactose, dextrin

PURPOSE

- effective in uterine discharge and bleeding, dysmenorrheal, intestinal bleeding and activation of GI system
-improving the immune functions of cancer patients after surgical resection of stomach, colon, or liver

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

- effective in uterine discharge and bleeding, dysmenorrheal, intestinal bleeding, and activation of GI system, 550-1100mg twice a day before meals
- effective in improving the immune functions of cancer patients after surgical resection of stomach, colon, or liver, 1100mg three times a day before meals

WARNINGS

- GI system:  may cause nausea, vomiting, diarrhea, or abdominal discomfort
- dizziness (one case), headache (one case), and constipation (three cases) were reported during clinical trials

DOSAGE & ADMINISTRATION

for oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MESIMA  
phellinus linteus mycelium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53144-1001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C) (PHELLINUS LINTEUS MYCELIUM - UNII:40K19XJV3C)	PHELLINUS LINTEUS MYCELIUM	1.1

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
ICODEXTRIN (UNII: 2NX48Z0A9G)

Product Characteristics
Color	brown (light brown)	Score	no score
Shape	OVAL (tablet)	Size	15mm
Flavor		Imprint Code	3;hp;x
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53144-1001-1	2 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/29/2012

Labeler - Yein Trading & Global Co., Ltd (557803795)

Registrant - Yein Trading & Global Co., Ltd (557803795)

Establishment
Name	Address	ID/FEI	Business Operations
Han Kook Sin Yak Pharmaceutical Co., Ltd.		689277536	manufacture(53144-1001)