STOMASIN- 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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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82871-301-01 Stomasin

Active Ingredients

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

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

Uses

for swelling and sore throat symptoms

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

Warnings

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

Keep out of reach of children

Warnings

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

Warnings

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

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

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

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

Inactive Ingredients

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

Stomasin Drug Facts Label

STOMASIN 
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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82871-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OSTERICUM GROSSESERRATUM ROOT (UNII: 9IGM98814N) (OSTERICUM GROSSESERRATUM ROOT - UNII:9IGM98814N) OSTERICUM GROSSESERRATUM ROOT250 mg
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE, UNSPECIFIED FORM1665 mg
FORSYTHIA VIRIDISSIMA FRUIT (UNII: P4ZY00SWES) (FORSYTHIA VIRIDISSIMA FRUIT - UNII:P4ZY00SWES) FORSYTHIA VIRIDISSIMA FRUIT835 mg
ARCTIUM LAPPA FRUIT (UNII: EA541308MV) (ARCTIUM LAPPA FRUIT - UNII:EA541308MV) ARCTIUM LAPPA FRUIT500 mg
PLATYCODON GRANDIFLORUM ROOT (UNII: 2DF0NS0O2Z) (PLATYCODON GRANDIFLORUM ROOT - UNII:2DF0NS0O2Z) PLATYCODON GRANDIFLORUM ROOT500 mg
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) (SAPOSHNIKOVIA DIVARICATA ROOT - UNII:8H84LFK2QD) SAPOSHNIKOVIA DIVARICATA ROOT500 mg
NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE) (NEPETA TENUIFOLIA FLOWERING TOP - UNII:2FN3BA1MZE) NEPETA TENUIFOLIA FLOWERING TOP250 mg
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K) (GLYCYRRHIZA URALENSIS ROOT - UNII:42B5YD8F0K) GLYCYRRHIZA URALENSIS ROOT250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
Product Characteristics
Colorblue (blue and dark green capsule) Scorescore with uneven pieces
ShapeCAPSULE (brown powder encapsulated in blue and dark green opaque capsule) Size22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82871-301-0110 in 1 BLISTER PACK; Type 0: Not a Combination Product07/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/13/2022
Labeler - MedicareBio.Co.Ltd (695630697)
Registrant - MedicareBio.Co.Ltd (695630697)
Establishment
NameAddressID/FEIBusiness Operations
MedicareBio.Co.Ltd695630697manufacture(82871-301)

Revised: 12/2023
Document Id: 0d8ccd5a-6a26-9524-e063-6394a90a2021
Set id: e3ac2145-22c6-eefe-e053-2995a90aaf17
Version: 4
Effective Time: 20231228
 
MedicareBio.Co.Ltd