Label: HANPOONG GAL CHEON XIN EXTRACT GRANULES- ephedrine hci bead

  • NDC Code(s): 82369-1104-1, 82369-1104-2
  • Packager: HANPOONG PHARM CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 3, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ephedrine 4.6 mg

  • 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.

  • 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.

  • 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

  • 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

  • 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

  • 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

  • PREGNANCY OR BREAST FEEDING

    ask health professional before use.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Product out boxProduct pouch

  • INGREDIENTS AND APPEARANCE
    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 finalpart34101/01/2022
    Labeler - HANPOONG PHARM CO.,LTD. (631169612)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANPOONG PHARM CO.,LTD.631169612manufacture(82369-1104)