Label: EPHEDRINE HYDROCHLORIDE tablet

  • 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 March 23, 2022

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

  • Drug Facts

    Active ingredient (in each tablet)
    Ephedrine Hydrochloride 12.5 mg

  • PURPOSE

    Purpose
    Bronchodilator

  • Use

     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 12 tablets in 24 hours

     use more than 8 tablets 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.
     if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use 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 a doctor or pharmacist before use if you are

     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 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 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

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

    Keep out of the reach of children.

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

  • Directions

    • do not take more than directed
      adults and children 12 years of age and overTake 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours
      children under 12 years of ageAsk a doctor

  • Other information

    • store in a dry place at 15° – 30°C (59° – 86°F).
  • INACTIVE INGREDIENT

    crospovidone, D&C yellow #10 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

  • Questions or comments?

    Call 1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

    RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    †Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
    ††This product is not manufactured or distributed by ARMSTRONG PHARMACEUTICALS, INC., owner of the registered trademark Primatene®.

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    Compare to the active ingredient in Primatene®††

    Asthma Relief

    EPHEDRINE HCl 12.5 mg / BRONCHODILATOR
    • Relief of mild intermittent asthma symptoms
    • Restores free breathing

    60 Tablets

    walgreen label

  • INGREDIENTS AND APPEARANCE
    EPHEDRINE HYDROCHLORIDE 
    ephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 1298
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9812-074 in 1 CARTON12/02/2021
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/02/2021
    Labeler - Walgreen Company (008965063)