Stomasin

Manufacturer
MedicareBio.Co.Ltd
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:25:15

Label at a glance#

ProductStomasin
Active ingredientOSTERICUM GROSSESERRATUM ROOT, CALCIUM SULFATE, UNSPECIFIED FORM, FORSYTHIA VIRIDISSIMA FRUIT, ARCTIUM LAPPA FRUIT, PLATYCODON GRANDIFLORUM ROOT, SAPOSHNIKOVIA DIVARICATA ROOT, NEPETA TENUIFOLIA FLOWERING TOP, GLYCYRRHIZA URALENSIS ROOT
Label structure12 sections

Indications and uses

for swelling and sore throat symptoms temporarily reduces fever; relieves swelling and sore throat for tonsillitis / peritonsillitis

Dosage and administration

Adults Take 2 capsules per time, 3 times a day Children 7 years to under 14 years 2/3 of the adult dose (4/3 capsules) Children 4 years to under 6 years 1/2 of the adult dose (1 capsule) Children 2 years to under 3 years 1/3 of the adult dose (2/3 capsule) Children under 1 years 1/4 of the adult dose (1/2 capsule) Dissolve it in lukewarm water before or between meals (between meals and between meals) and take it s...

Storage and handling

protect from excessive moisture, store at 1~30℃(33.8~86℉)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Gypsum fibrosum extract, Forsythia viridissima fruit extract, Arctium lappa fruit extract, Platycodon grandiflorus root extract, Saposhnikovia divaricata root extract, Glycyrrhiza uralensis root extract, Ostericum koreanum extract, Schizonepeta tenuifolia extract

Purpose

OTC - PURPOSE SECTION

antipyretic, anti-inflammatory, anti-corona virus (omicron variant)

Uses

INDICATIONS & USAGE SECTION

for swelling and sore throat symptoms

temporarily reduces fever; relieves swelling and sore throat for tonsillitis / peritonsillitis

Warnings

OTC - DO NOT USE SECTION

Do not use in the following patients
Because this drug contains lactose, it should not be administered to patients with genetic problems such as galactose intolerance, lactose intolerance, or glucose-galactose malabsorption.: See Insert Paper

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

OTC - STOP USE SECTION

In the following cases, stop using this drug immediately and consult a doctor, carry this Insert Paper with you. : See Insert Paper

Warnings

OTC - WHEN USING SECTION

The following people should not use this drug. Infants under 3 months

The following people should consult with a doctor before use if you have .: See Insert Paper

Warnings

WARNINGS SECTION

Storage precautions : See Insert Paper

If pregnant or breast-feeding, ask a health professional before use

In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults Take 2 capsules per time, 3 times a day
Children 7 years to under 14 years 2/3 of the adult dose (4/3 capsules)
Children 4 years to under 6 years 1/2 of the adult dose (1 capsule)
Children 2 years to under 3 years 1/3 of the adult dose (2/3 capsule)
Children under 1 years 1/4 of the adult dose (1/2 capsule)
Dissolve it in lukewarm water before or between meals (between meals and between meals) and take it slowly in small portions while moistening the mouth or throat (do not swallow capsules).

Other Information

STORAGE AND HANDLING SECTION

protect from excessive moisture, store at 1~30℃(33.8~86℉)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, FD&C blue no.3, FD&C yellow no.5, lactose hydrate (cow, milk), magnesium stearate, silicon dioxide, gelatin

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stomasin Drug Facts LabelStomasin Drug Facts Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82871-301-012025-01-30C16284748780-12cef2736-5f2a-d83d-e063-dadaa90ab31f82871-301-01 Stomasin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82871-301-01Stomasin10 in 1 BLISTER PACKCAPSULE, COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82871-301STOMASIN (GYPSUM FIBROSUM EXTRACT, FORSYTHIA VIRIDISSIMA FRUIT EXTRACT, ARCTIUM LAPPA FRUIT EXTRACT, PLATYCODON GRANDIFLORUS ROOT EXTRACT, SAPOSHNIKOVIA DIVARICATA ROOT EXTRACT, GLYCYRRHIZA URALENSIS ROOT EXTRACT, OSTERICUM KOREANUM EXTRACT, SCHIZONEPETA TENUIFOLIA EXTRACT) CAPSULE, COATED [MEDICAREBIO.CO.LTD]4Legacy NDC, 1 package rows20231228_e3ac2145-22c6-eefe-e053-2995a90aaf17.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82871-30182871-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d8ccd5a-6a26-9524-e063-6394a90a2021e3ac2145-22c6-eefe-e053-2995a90aaf172023-12-28WarningsExact identifier
spl id: 0d8ccd5a-6a26-9524-e063-6394a90a2021
spl set id: e3ac2145-22c6-eefe-e053-2995a90aaf17

Reported adverse events (FAERS/openFDA)#

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