Label: BRONKAID DUAL ACTION FORMULA- ephedrine sulfate and guaifenesin tablet, coated

  • NDC Code(s): 69536-425-24, 69536-425-60
  • Packager: Foundation Consumer Healthcare LLC
  • 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 September 19, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Ephedrine sulfate 25 mgBronchodilator
    Guaifenesin 400 mgExpectorant
  • Uses

    • for temporary relief of mild symptoms of intermittent asthma:
      • wheezing
      • tightness of chest
      • shortness of breath
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive
  • 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 more than 3 days a week
    • have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse.

    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
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a cough which is accompanied by excessive phlegm (mucus)

    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 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
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    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

    magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • 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 15205

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    NDC 69536-425-24

    Ephedrine Sulfate/Bronchodilator
    Guaifenesin/Expectorant

    BRONKAID®

    STRONGEST FORMULA
    available in a 1 caplet dose

    DUAL ACTION FORMULA:

    Restores Free Breathing
    Loosens Phlegm

    Relief of Mild
    Intermittent
    Asthma Symptoms

    PHARMACIST
    RECOMMENDED

    24
    CAPLETS

    Principal Display Panel - 24 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    BRONKAID   DUAL ACTION FORMULA
    ephedrine sulfate and guaifenesin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-425
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE SULFATE25 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code BRONKAID
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-425-244 in 1 CARTON01/01/2006
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69536-425-605 in 1 CARTON01/01/2006
    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 FINALpart34101/01/2006
    Labeler - Foundation Consumer Healthcare LLC (079675882)