NDC 72850-0005 Decasilin

Poncirus Trifoliata Fruit, Peony Root, Platycodon Root

NDC Product Code 72850-0005

NDC CODE: 72850-0005

Proprietary Name: Decasilin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Poncirus Trifoliata Fruit, Peony Root, Platycodon Root What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
RED (C48326)
Shape: OVAL (C48345)
Size(s):
20 MM
Score: 1

NDC Code Structure

  • 72850 - Chunwoo Pharmaceutical Co., Ltd.

NDC 72850-0005-1

Package Description: 10 CAPSULE in 1 BLISTER PACK

NDC Product Information

Decasilin with NDC 72850-0005 is a a human over the counter drug product labeled by Chunwoo Pharmaceutical Co., Ltd.. The generic name of Decasilin is poncirus trifoliata fruit, peony root, platycodon root. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Decasilin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PONCIRUS TRIFOLIATA FRUIT 17.12 1/1001
  • PAEONIA LACTIFLORA ROOT 22.95 1/1001
  • GINGER 5.82 1/1001
  • PLATYCODON GRANDIFLORUS ROOT 17.12 1/1001
  • JUJUBE FRUIT 17.12 1/1001
  • LICORICE 17.12 1/1001

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.
Labeler Code: 72850
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Decasilin Product Label Images

Decasilin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Poncirus Trifoliata Fruit 17.12%% --------------------------------------------------------- ant-inflammatoryPeony Root 22.95% ----------------------------------------------------------------------- ant-inflammatoryPlatycodon Root 17.12% ------------------------------------------------------------------ ant-inflammatoryGinger 5.82% ----------------------------------------------------------------------------- ant-inflammatoryJujube 17.12% ---------------------------------------------------------------------------- ant-inflammatoryLicorice 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 dosageKeep out of reach of ChildrenOther 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.

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