BRONCHIAL ASTHMA RELIEF (EPHEDRINE HCL, GUAIFENESIN) TABLET [WALGREENS COMPANY]

BRONCHIAL ASTHMA RELIEF (EPHEDRINE HCL, GUAIFENESIN) TABLET [WALGREENS COMPANY]
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NDC 0363-2529-67
Set ID 10816e9d-0c53-424b-b482-fdd01a4d8525
Category HUMAN OTC DRUG LABEL
Packager Walgreens Company
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number PART341
  • 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 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
  • 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

    74ac83c5-figure-01
  • INGREDIENTS AND APPEARANCE
    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)

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