Label: BRONKAID MAX- ephedrine sulfate tablet, coated

  • NDC Code(s): 69536-250-24, 69536-250-60
  • Packager: Foundation Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 14, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Ephedrine sulfate 25 mg

  • Purpose

    Bronchodilator

  • Uses

    • 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 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 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

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc

  • Questions or comments?

    call 1-855-565-9800 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Dist. by: Foundation Consumer Healthcare, LLC.
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    NDC 69536-250-24

    BRONKAID® MAX

    NEW FORMULA

    Ephedrine Sulfate 25 mg/
    Bronchodilator

    STRONGEST FORMULA
    available in a 1 caplet dose

    ✓ Restores
    Free Breathing

    Relief of Mild
    Intermittent
    Asthma Symptoms

    PHARMACIST
    RECOMMENDED BRAND

    24
    CAPLETS

    PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    BRONKAID   MAX
    ephedrine sulfate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-250
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code BRONK25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-250-244 in 1 CARTON09/01/2020
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69536-250-605 in 1 CARTON09/01/2020
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01209/01/2020
    Labeler - Foundation Consumer Healthcare LLC (079675882)