HANPOONG GAL CHEON XIN EXTRACT GRANULES- ephedrine hci bead 
HANPOONG PHARM CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ephedrine 4.6 mg

bronchodilator

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

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.

■ 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.

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

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

■ 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

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

ask health professional before use.

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

■ 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

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

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

Product out boxProduct pouch

HANPOONG GAL CHEON XIN EXTRACT GRANULES 
ephedrine hci bead
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82369-1104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE4.6 mg  in 4 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorbrownScorescore with uneven pieces
ShapeSize1mm
FlavorANISEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82369-1104-1120 in 1 BOX01/01/2022
1NDC:82369-1104-24 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/202209/30/2022
Labeler - HANPOONG PHARM CO.,LTD. (631169612)
Establishment
NameAddressID/FEIBusiness Operations
HANPOONG PHARM CO.,LTD.631169612manufacture(82369-1104)

Revised: 12/2022
 
HANPOONG PHARM CO.,LTD.