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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 28, 2023

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)