Label: DECASILIN- poncirus trifoliata fruit, peony root, platycodon root capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 72850-0005-1 - Packager: Chunwoo Pharmaceutical Co., Ltd.
- 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.
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- Official Label (Printer Friendly)
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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
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
- INDICATION & USAGE SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DECASILIN
poncirus trifoliata fruit, peony root, platycodon root capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72850-0005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2) (PONCIRUS TRIFOLIATA FRUIT - UNII:44445L49J2) PONCIRUS TRIFOLIATA FRUIT 17.12 in 100 PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) (PAEONIA LACTIFLORA ROOT - UNII:3Z3866YW6P) PAEONIA LACTIFLORA ROOT 22.95 in 100 GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 5.82 in 100 PLATYCODON GRANDIFLORUS ROOT (UNII: 2DF0NS0O2Z) (PLATYCODON GRANDIFLORUS ROOT - UNII:2DF0NS0O2Z) PLATYCODON GRANDIFLORUS ROOT 17.12 in 100 JUJUBE FRUIT (UNII: G55HNL2C70) (JUJUBE FRUIT - UNII:G55HNL2C70) JUJUBE FRUIT 17.12 in 100 LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE 17.12 in 100 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72850-0005-1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/19/2019 Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065) Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065) Establishment Name Address ID/FEI Business Operations Chunwoo Pharmaceutical Co., Ltd. 688729065 manufacture(72850-0005)