Okcheonwon
Trichosanthes Kirilowii Root, Pueraria Lobata Root, Liriope Muscari Root, Ophiopogon Japonicus Root, Prunus Mume Fruit, Astragalus Mongholicus Root, Asian Ginseng, Licorice
Chunwoo Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 72850-0008Okcheonwon also known as Trichosanthes Kirilowii Root, Pueraria Lobata Root, Liriope Muscari Root, Ophiopogon Japonicus Root, Prunus Mume Fruit, Astragalus Mongholicus Root, Asian Ginseng, Licorice is a human otc drug labeled by 'Chunwoo Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Okcheonwon is 72850-0008. This drug is available in dosage form of Pill. The names of the active, medicinal ingredients in Okcheonwon drug includes Asian Ginseng - 13.9 mg/10g Astragalus Mongholicus Root - 13.9 mg/10g Licorice - 13.9 mg/10g Liriope Muscari Root - 13.9 mg/10g Ophiopogon Japonicus Root - 13.9 mg/10g Prunus Mume Fruit - 13.9 mg/10g Pueraria Montana Var. Lobata Root - 20.8 mg/10g Trichosanthes Kirilowii Root - 20.8 mg/10g . The currest status of Okcheonwon drug is Active.
Drug Information:
| Drug NDC: | 72850-0008 |
| 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: | Okcheonwon |
| 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: | Trichosanthes Kirilowii Root, Pueraria Lobata Root, Liriope Muscari Root, Ophiopogon Japonicus Root, Prunus Mume Fruit, Astragalus Mongholicus Root, Asian Ginseng, Licorice |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Chunwoo Pharmaceutical Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pill |
| 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: | ASIAN GINSENG - 13.9 mg/10g
ASTRAGALUS MONGHOLICUS ROOT - 13.9 mg/10g
LICORICE - 13.9 mg/10g
LIRIOPE MUSCARI ROOT - 13.9 mg/10g
OPHIOPOGON JAPONICUS ROOT - 13.9 mg/10g
PRUNUS MUME FRUIT - 13.9 mg/10g
PUERARIA MONTANA VAR. LOBATA ROOT - 20.8 mg/10g
TRICHOSANTHES KIRILOWII ROOT - 20.8 mg/10g
|
| 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: | 12 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | Chunwoo Pharmaceutical 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: | CUQ3A77YXI
922OP8YUPF
61ZBX54883
8PHD8TAO0Q
90PS6JV9GZ
639190I8CU
PET93F4I3C
V409XGE0TS
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 72850-0008-3 | 1 CASE in 1 BOX (72850-0008-3) / 30 BLISTER PACK in 1 CASE (72850-0008-2) / 15 g in 1 BLISTER PACK (72850-0008-1) | 12 Jan, 2022 | N/A | No |
| 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 diabetes
Product Elements:
Okcheonwon trichosanthes kirilowii root, pueraria lobata root, liriope muscari root, ophiopogon japonicus root, prunus mume fruit, astragalus mongholicus root, asian ginseng, licorice licorice licorice trichosanthes kirilowii root trichosanthes kirilowii root pueraria montana var. lobata root pueraria montana var. lobata root liriope muscari root liriope muscari root prunus mume fruit prunus mume fruit astragalus mongholicus root astragalus mongholicus root asian ginseng asian ginseng lactose monohydrate ophiopogon japonicus root ophiopogon japonicus root none
Indications and Usage:
Uses thirst from diabetes
Warnings:
Warnings warnings do not use if you have galactose intolerance lapp lactase deficiency glucose-galactose malabsorption (this medicine contains lactose) ask a doctor before use if you are a hypertensive a heart or kidney patient an edema patient a patient who is being treated by a doctor or taking other medications. an elderly person (in general, elderly people should take with care, such as reducing their dosage, as their physiological function has deteriorated.) a child (the safety of children's use is not established. (less experience in use)) stop use and ask a doctor, pharmacist or health professionals and bring this if you have following symptoms after use: pseudohyperaldosteronism: reduced urine volume, swollen face, swollen hands and feet, heavy eyelids, firm hands, increased blood pressure, headache, and etc. (mediciness with a maximum daily dose of 1g or more may develop hypoglycemia, blood pressure rise, low sodium body fluid, edema, weight gain, and etc. caused by pseydohype
Read more...raldosteronism if taken continuously for a long time. therefore, make sufficient observations (measurement of serum potassium levels) and stop taking if there is any abnormality.) myopathy: myopathy (muscle disease) may occur as a result of hypokalemia, so take sufficient observation and stop taking if you find any abnormalities such as feeling helplessness, limb cramps, paralysis, and etc. skin trouble: a rash, itch, bloodshot, and etc. digestive system disorder: anorexia, stomach discomfort, nausea, vomiting, and etc. liver disorder: jaundice, fatigue, and etc. interstitial lung disease: difficult to breathe, fever, and etc. accompanied by a cough. urinary system disorder: dysuria the autonomic system disorder: insomnia, excessive sweating, fast pulse, frequent urination, palpitations, feeling helplessness, excitement, and etc. if there is no improvement in symptoms after taking it for one month other warnings do not take more than directed when taken with potassium-containing agents, licorice-containing agents, glycirizinic acid or other related agents, loop diuretics (furosemide, ethacrynic acid), or thiazide diuretics (trichlormethiazide) and myopathy, it is likely to appear due to gastric aldosterone (pseudohyperaldosteronism) or hypokalemia if taken with other herbal medicines, be careful of overlapping of the crude medicines. in principle, you should not to take it continuously for a long time, but if it is necessary, consult with a doctor, herb doctor, dentist, pharmacist, or other health care professionals. it is easy to experience symptoms such as insomnia, hyperhidrosis, rapid pulse, frequent urination, palpitations, general fatigue, and mental excitement when use with ephedra sinica stem or ephedrine-containing agents, mao inhibitors, thyroid agents (thyroxine, liothyronine), catecholamine (epinephrine, isoprenaline) and xanthine agents (theophylline, diprophylline) so take it carefully, such as reducing the dose.
Dosage and Administration:
Directions for adults, take 1 case (15 pills)l a day, before or between meals
Package Label Principal Display Panel:
Okcheonwon okcheonwon