Label: EPHEDRINE SULFATE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 2, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

    Active ingredient (in each caplet)
    Ephedrine Sulfate 25 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 6 caplets in 24 hours

     use more than 4 caplets 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 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 over
    take 1 caplet every 4 hours as needed.
    Do not take more than 6 caplets in 24
    hours or as directed by a doctor.
    children under 12
    years of age
    do not use

  • Other information

     each caplet contains: calcium 20 mg

     store in a dry place at 15° – 30°C (59° – 86°F)

  • INACTIVE INGREDIENT

    dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.

  • Questions or comments?

    Call 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    * This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC., owner of the registered trademark
    Bronkaid®.

    RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION
    TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS

    Product of India. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Bronkaid® Max*

    MAXIMUM STRENGTH**
    Asthma Relief
    EPHEDRINE SULFATE CAPLETS, 25 mg Bronchodilator
    **STRONGEST 1 CAPLET DOSE AVAILABLE WITHOUT
    A PRESCRIPTION

    Relieves mild, intermittent asthma
    symptoms & restores free breathing

    60 Caplets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    EPHEDRINE SULFATE 
    ephedrine sulfate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-922
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE SULFATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 57;89
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-922-075 in 1 CARTON12/28/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/28/2022
    Labeler - CVS Pharmacy, Inc (062312574)