BRONCHIAL ASTHMA RELIEF - ephedrine hcl, guaifenesin tablet 
Walgreens Company

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.

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Bronchial Asthma Relief

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

PURPOSE

Bronchodilator

Expectorant

INDICATIONS AND USAGE

WARNINGS

Asthma alert: Because asthma may be life threatening, see a doctor if you

These may be signs that your asthma is getting worse

DO NOT USE

ASK DOCTOR

before use if you have:

ASK DOCTOR/PHARMACIST

before use if you are

STOP USE

and ask a doctor if

WHEN USING

this product

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

adults and children 12 years of age and overtake 1-2 tablets every  4 hours as needed, not to exceed 12 tablets in 24 hours
children under 12 years of ageask a doctor

Other information

store at room temperature, USP

INACTIVE INGREDIENT

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

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

Compare to Primatene®
active ingredients#

MAXIMUM SALE: ONE PACKAGE PER CUSTOMER

NOT FOR SALE TO MINORS

74ac83c5-figure-01
BRONCHIAL ASTHMA RELIEF 
ephedrine hcl, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2529
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (pale yellow) Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code CPC;2529
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-2529-674 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/13/2002
Labeler - Walgreens Company (008965063)
Registrant - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE(0363-2529)

Revised: 9/2012
Document Id: 74ac83c5-db2e-485f-8fe4-0c29f94e1006
Set id: 10816e9d-0c53-424b-b482-fdd01a4d8525
Version: 3
Effective Time: 20120917
 
Walgreens Company