Bronkaid dual action formula tablet, coated

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients (in each caplet) Purpose
Ephedrine sulfate 25 mg Bronchodilator
Guaifenesin 400 mg Expectorant

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 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
  • in children under 12 years of age

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 persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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

  • each caplet contains:15 mg magnesium
  • store at room temperature. Avoid excessive heat and humidity.

Inactive ingredients

carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, magnesium trisilicate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch

Questions or comments?

1-800-986-0369
(Mon Fri 9AM 5PM EST) or www.bayercare.com

Ingredients and appearance - Product information

Bronkaid dual action formula tablet, coated- Ephedrine sulfate and guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0280-0880
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ephedrine sulfate ( UNII: U6X61U5ZEG)( Ephedrine - UNII: GN83C131XS ) 25 mgin 1
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 1

Inactive Ingredients

Ingredient Name Code
Carnauba wax ( UNII: R12CBM0EIZ)
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Magnesium trisilicate ( UNII: C2E1CI501T)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidones ( UNII: FZ989GH94E)

Product Characteristics

Color WHITE Score 1
Shape OVAL Size 18 mm
Imprint Code BRONKAID

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Bayer HealthCare Consumer Care( 785159372)

Establishment

Name ID/FEI Business Operations
Bayer HealthCare Consumer Care 785159372 MANUFACTURE( 0280-0880), PACK( 0280-0880), LABEL( 0280-0880)

Principal display panel - 60 caplet blister pack carton

STRONGEST FORMULA AVAILABLE
in a OneCaplet Dose!

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Drug Facts

BRONKAID ®
DUAL
ACTION
FORMULA

Ephedrine Sulfate 25mg / Bronchodilator
Guaifenesin 400mg / Expectorant

Relief of
BRONCHIAL CONGESTION
and MILD INTERMITTENT
ASTHMA SYMPTOMS

  • Restores Free Breathing
    and
  • Loosens Phlegm

60 COATED CAPLETS