Label: DECASILIN- poncirus trifoliata fruit, peony root, platycodon root capsule

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 12, 2019

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

  • ACTIVE INGREDIENT

    Poncirus Trifoliata Fruit 17.12%% --------------------------------------------------------- ant-inflammatory

    Peony Root 22.95% ----------------------------------------------------------------------- ant-inflammatory

    Platycodon Root 17.12% ------------------------------------------------------------------ ant-inflammatory

    Ginger 5.82% ----------------------------------------------------------------------------- ant-inflammatory

    Jujube 17.12% ---------------------------------------------------------------------------- ant-inflammatory

    Licorice 17.12% --------------------------------------------------------------------------- ant-inflammatory

  • INACTIVE INGREDIENT

    Light Anhydrous silicic Acid, Lactose, Corn Starch, Food Red No. 40, Food Yellow No. 5, Food Blue No. 1

  • PURPOSE

    Treats suppurative skin ailment with rubefaction and swell

    ■stye ■inflammation ■boil ■suppuration

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    Do not take if you have

    ■a headache, a chill, or fever with the symptom

    ■an abscessus frigidus(cold abscessus), or a chronic abscess.

    ■galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption (this medicine contains lactose)

    Ask a health professional before use it if you

    ■have high blood pressure

    ■have a problem with heart or kidney

    ■have edema

    ■are on other medication

    ■are pregnant, breast feeding, or have chance to get pregnant

    ■have a history of allergic reaction to medicines

    ■are under 12

    ■are sensitive or have a history of allergic reaction to Food Yellow No. 5 (Sunset Yellow FCF)

    Stop using and ask doctor

    ■If you have following symptom

    ■pseudoaldosteronism: reduce in urine volume, stiffness of hand, have swollen hands and feet, heavy feelings in eye lids, high blood pressure, or headache (taking Licorice more than 1 g a day for long period might cause symptoms of pseudoaldosteronism such as hypokalemia, rise in blood pressure, or low flow of sodium.)

    ■myopathy: if feeling impuissance side effect from Hypokalemia such as convulsion or numbness

    ■skin trouble: a rash, flare, or pruritus

    ■feeling discomfort on upper stomach

    ■ if symptoms persist after 5~6 days of using.

    When using this product

    ■ using for long term is not recommended, but if needed, ask a health professions.

    ■ Do not exceed the recommended dosage

    Keep out of reach of Children

    Other information

    ■ keep in dry and cool area, out of direct sunlight if possible

    ■ Keep this label and enclosed materials in the box. They contain important information and putting in other container may cause misuse.

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    Take two caplets three times a day while symptoms persist.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DECASILIN 
    poncirus trifoliata fruit, peony root, platycodon root capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72850-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2) (PONCIRUS TRIFOLIATA FRUIT - UNII:44445L49J2) PONCIRUS TRIFOLIATA FRUIT17.12   in 100 
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) (PAEONIA LACTIFLORA ROOT - UNII:3Z3866YW6P) PAEONIA LACTIFLORA ROOT22.95   in 100 
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER5.82   in 100 
    PLATYCODON GRANDIFLORUS ROOT (UNII: 2DF0NS0O2Z) (PLATYCODON GRANDIFLORUS ROOT - UNII:2DF0NS0O2Z) PLATYCODON GRANDIFLORUS ROOT17.12   in 100 
    JUJUBE FRUIT (UNII: G55HNL2C70) (JUJUBE FRUIT - UNII:G55HNL2C70) JUJUBE FRUIT17.12   in 100 
    LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE17.12   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72850-0005-110 in 1 BLISTER PACK; Type 0: Not a Combination Product10/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/19/2019
    Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chunwoo Pharmaceutical Co., Ltd.688729065manufacture(72850-0005)