BRONCHIAL ASTHMA RELIEF- ephedrine hcl, guaifenesin tablet

Bronchial Asthma Relief by

Drug Labeling and Warnings

Bronchial Asthma Relief by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Contract Pharmacal Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

PURPOSE

Bronchodilator

Expectorant

INDICATIONS AND USAGE

• for temporarily relief of mild symptoms of intermittent asthma:
• wheezing
• tightness of chest
• shortness of breath
• helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, 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 12 tablets in any day
• use more than 8 tablets a day for more than 3 days a week
• have more than 2 asthma attacks a week

These may be signs that your asthma is getting worse

DO NOT USE

• unless a doctor said you have asthma
• if you are now taking prescription monoamine oxidase inhibitor (MAIO) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAIO drug. If you do not know if your prescription drug contains an MAIO, ask a doctor or pharmacist before taking this product.

ASK 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 enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

ASK DOCTOR/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)

STOP USE

and ask a doctor if

• your asthma is getting worse (see Asthma alert)
• you have difficulty sleeping
• you have rapid heartbeat
• 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.

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

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact Poison Control Center right away.

DOSAGE AND ADMINISTRATION

• do not exceed dosage
• this adult product is not intended for use in children under 12 years of age

• adults and children 12 years of age and over: take 1-2 tablets every 4 hours as needed, not to exceed 12 tablets in 24 hours
• children under 12 years of age: ask a doctor

SPL UNCLASSIFIED SECTION

Other information

store at room temperature, USP

INACTIVE INGREDIENT

D&C Yellow #10 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silica and Stearic Acid

SPL UNCLASSIFIED SECTION

REV 05/12

Intentional abuse of this product can be harmful or fatal

Distribution of this product requires a DEA License

Tamper evident: Do Not USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

GLUTEN FREE

‡Walgreens Pharmacist Survey Study, November 2010

#This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Primatene®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS PHARMACIST RECOMMENDED‡

Ephedrine HCl, USP 12.5 mg/ Bronchodilator
Guaifenesin, USP 200 mg/ Expectorant

• Helps breathing without drowsiness
• Restores free breathing
• Loosens phlegm

Compare to Primatene®
active ingredients#

MAXIMUM SALE: ONE PACKAGE PER CUSTOMER

NOT FOR SALE TO MINORS

INGREDIENTS AND APPEARANCE

BRONCHIAL ASTHMA RELIEF 
ephedrine hcl, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-2529
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	YELLOW (pale yellow)	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	CPC;2529
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-2529-67	4 in 1 CARTON
1		15 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/13/2002

Labeler - Walgreens Company (008965063)

Registrant - Contract Pharmacal Corp (968334974)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		968334974	MANUFACTURE(0363-2529)