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Bronkaid Dual Action Formula by Foundation Consumer Healthcare LLC

Dosage form: tablet, coated
Ingredients: EPHEDRINE SULFATE 25mg, GUAIFENESIN 400mg
Labeler: Foundation Consumer Healthcare LLC
NDC Code: 69536-425

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.

Bronkaid®
Dual Action Formula

Drug Facts

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

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

BRONKAID   DUAL ACTION FORMULA
ephedrine sulfate and guaifenesin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-425
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE SULFATE (EPHEDRINE) EPHEDRINE SULFATE25 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
STEARIC ACID 
TALC 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeBRONKAID
Contains    
Packaging
#Item CodePackage Description
1NDC:69536-425-244 BLISTER PACK in 1 CARTON
16 TABLET, COATED in 1 BLISTER PACK
2NDC:69536-425-605 BLISTER PACK in 1 CARTON
212 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2006
Labeler - Foundation Consumer Healthcare LLC (079675882)

Revised: 09/2016
 
Foundation Consumer Healthcare LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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