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


Medicarebio.co.ltd
Human Otc Drug
NDC 82871-301
Stomasin also known as 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 is a human otc drug labeled by 'Medicarebio.co.ltd'. National Drug Code (NDC) number for Stomasin is 82871-301. This drug is available in dosage form of Capsule, Coated. The names of the active, medicinal ingredients in Stomasin drug includes Arctium Lappa Fruit - 500 mg/1 Calcium Sulfate, Unspecified Form - 1665 mg/1 Forsythia Viridissima Fruit - 835 mg/1 Glycyrrhiza Uralensis Root - 250 mg/1 Nepeta Tenuifolia Flowering Top - 250 mg/1 Ostericum Grosseserratum Root - 250 mg/1 Platycodon Grandiflorum Root - 500 mg/1 Saposhnikovia Divaricata Root - 500 mg/1 . The currest status of Stomasin drug is Active.

Drug Information:

Drug NDC: 82871-301
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Stomasin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: 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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Medicarebio.co.ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule, Coated
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ARCTIUM LAPPA FRUIT - 500 mg/1
CALCIUM SULFATE, UNSPECIFIED FORM - 1665 mg/1
FORSYTHIA VIRIDISSIMA FRUIT - 835 mg/1
GLYCYRRHIZA URALENSIS ROOT - 250 mg/1
NEPETA TENUIFOLIA FLOWERING TOP - 250 mg/1
OSTERICUM GROSSESERRATUM ROOT - 250 mg/1
PLATYCODON GRANDIFLORUM ROOT - 500 mg/1
SAPOSHNIKOVIA DIVARICATA ROOT - 500 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 13 Jul, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:MedicareBio.Co.Ltd
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:EA541308MV
WAT0DDB505
P4ZY00SWES
42B5YD8F0K
2FN3BA1MZE
9IGM98814N
2DF0NS0O2Z
8H84LFK2QD
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
82871-301-0110 CAPSULE, COATED in 1 BLISTER PACK (82871-301-01)13 Jul, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

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

Product Elements:

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 ostericum grosseserratum root ostericum grosseserratum root fd&c yellow no. 5 magnesium stearate calcium sulfate, unspecified form calcium cation forsythia viridissima fruit forsythia viridissima fruit arctium lappa fruit arctium lappa fruit platycodon grandiflorum root platycodon grandiflorum root saposhnikovia divaricata root saposhnikovia divaricata root fd&c blue no. 1 nepeta tenuifolia flowering top nepeta tenuifolia flowering top glycyrrhiza uralensis root glycyrrhiza uralensis root lactose monohydrate silicon dioxide gelatin, unspecified blue and dark green capsule brown powder encapsulated in blue and dark green opaque capsule

Indications and Usage:

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

Warnings:

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

Do Not Use:

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

When Using:

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

Dosage and Administration:

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).

Stop Use:

Warnings in the following cases, stop using this drug immediately and consult a doctor, carry this insert paper with you. : see insert paper

Package Label Principal Display Panel:

Display panel stomasin drug facts label


Comments/ Reviews:

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