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

Bronkaid by

Drug Labeling and Warnings

Bronkaid by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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 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

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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

INGREDIENTS AND APPEARANCE

BRONKAID   DUAL ACTION FORMULA
ephedrine sulfate and guaifenesin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-425
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE SULFATE	25 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	BRONKAID
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-425-24	4 in 1 CARTON	01/01/2006
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69536-425-60	5 in 1 CARTON	01/01/2006
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/2006

Labeler - Foundation Consumer Healthcare LLC (079675882)