Label: HANPOONG BEAT COLD- ephedrine hci tablet

  • NDC Code(s): 82369-1111-1, 82369-1111-2
  • 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 10, 2021

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

  • ACTIVE INGREDIENT

    Ephedrine HCl 5.34 mg

  • PURPOSE

    Bronchodilator

  • WHEN USING

    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 28 sachets in 24 hours
    ■ use more than 18 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

    ■ 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

    ■ taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
    ■ taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

  • WHEN USING

    When using this product
    ■ 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

    Stop use and ask a doctor 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

    If pregnant or breast-feeding, ask health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • INDICATIONS & USAGE

    Directions
    ■ Do not take more than directed

  • DOSAGE & ADMINISTRATION

    ■ 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

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

  • INACTIVE INGREDIENT

    Croscarmellose sodium, Herbal extract (Cinnamomum cassia, Ephedra, Ginger, Jujube, Kudzu, Licorice, Paeonia lactiflora root), Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol 6000, Silicon dioxide, Titanium oxide,
    FD&C Blue No. 1, FD&C Red No. 40, Food Yellow No.5 Aluminium Lake

  • QUESTIONS

    Questions or comments? +1-800-829-4933

  • PRINCIPAL DISPLAY PANEL

    Product out boxProduct sachet

  • INGREDIENTS AND APPEARANCE
    HANPOONG BEAT COLD 
    ephedrine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82369-1111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE5.34 mg  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    JUJUBE FRUIT (UNII: G55HNL2C70)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GINGER (UNII: C5529G5JPQ)  
    LICORICE (UNII: 61ZBX54883)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    EPHEDRA SINICA STEM (UNII: 55L3XLO37E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82369-1111-11 in 1 BOX01/01/2022
    1NDC:82369-1111-216 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/2022
    Labeler - HANPOONG PHARM CO.,LTD. (631169612)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANPOONG PHARM CO.,LTD.631169612manufacture(82369-1111)