NDC 82369-1104 Hanpoong Gal Cheon Xin Extract Granules

Ephedrine Hci

NDC Product Code 82369-1104

NDC CODE: 82369-1104

Proprietary Name: Hanpoong Gal Cheon Xin Extract Granules 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: Ephedrine Hci 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):
BROWN (C48332)
Size(s):
1 MM
Flavor(s):
ANISE (C73361)

NDC Code Structure

  • 82369 - Hanpoong Pharm Co.,ltd.
    • 82369-1104 - Hanpoong Gal Cheon Xin Extract Granules

NDC 82369-1104-1

Package Description: 120 POUCH in 1 BOX > 4 g in 1 POUCH (82369-1104-2)

NDC Product Information

Hanpoong Gal Cheon Xin Extract Granules with NDC 82369-1104 is a a human over the counter drug product labeled by Hanpoong Pharm Co.,ltd.. The generic name of Hanpoong Gal Cheon Xin Extract Granules is ephedrine hci. The product's dosage form is bead and is administered via oral form.

Dosage Form: Bead - A solid dosage form in the shape of a small ball.

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.

Hanpoong Gal Cheon Xin Extract Granules 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.


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.

  • CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
  • LICORICE (UNII: 61ZBX54883)
  • MAGNOLIA SPRENGERI FLOWER BUD (UNII: 138CR0TWEI)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • GINGER (UNII: C5529G5JPQ)
  • CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • EPHEDRA SINICA STEM (UNII: 55L3XLO37E)
  • JUJUBE FRUIT (UNII: G55HNL2C70)

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.

Product Labeler Information

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

Labeler Name: Hanpoong Pharm Co.,ltd.
Labeler Code: 82369
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-01-2022 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hanpoong Gal Cheon Xin Extract Granules 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

Otc - Active Ingredient

Ephedrine 4.6 mg

Otc - Purpose

Bronchodilator

Indications & Usage

For temporary relief of mild symptoms of intermittent asthma: ■ wheezing ■ tightness of chest ■ shortness of breath

Warnings

Asthma alert: Because asthma may be life threatening, see a doctor if you

■ are not better in 60 minutes

■ get worse

■ need more than 32 sachets in 24 hours

■ use more than 21 sachets in 24 hours for 3 or more days a week

■ have more than 2 asthma attacks in a week

■ These may be signs that your asthma is getting worse.

■ This product will not give you asthma relief as quickly as an inhaled bronchodilator.

Otc - Do Not Use

■ unless a doctor said you have asthma■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

If you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes

■ thyroid disease ■ seizures ■ narrow angle glaucoma ■ a psychiatric or emotional condition ■ trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

If you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ thyroid disease ■ seizures ■ narrow angle glaucoma ■ a psychiatric or emotional condition ■ trouble urinating due to an enlarged prostate gland

Otc - When Using

■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Otc - Stop Use

If ■ your asthma is getting worse (see Asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure

Otc - Pregnancy Or Breast Feeding

Ask health professional before use.

Otc - Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

■ do not take more than directed

■ adults and children 12 years of age and over: oral dose is 12.5 to 25 milligrams every 4 hours as needed. Do not take more than 150 milligrams in 24 hours

■ children under 12 years of age: ask a doctor

Storage And Handling

■ store in a cool, dry place between 1℃~30℃ (33.8℉~86℉)

Inactive Ingredient

Corn starch, Herbal extract (Cinnamomum cassia, Cnidium officinale root, Ephedra, Ginger, Jujube, Kudzu, Licorice, Magnoliae flos, Paeonia lactiflora root), Hydroxyproply cellulose, Lactose monohydrate, Magnesium stearate, Silicon dioxide, Sucrose esters of fatty acids

* Please review the disclaimer below.