Label: BRONCHIAL ASTHMA RELIEF - guaifenesin and ephedrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    (in each tablet)

    Ephedrine HCl, USP 12.5 mg

    Guaifenesin, USP 200 mg

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  • PURPOSE

    Bronchodilator

    Expectorant

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  • 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
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  • 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

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  • 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.
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  • 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
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  • 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)
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  • 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.
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  • 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
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  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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
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  • SPL UNCLASSIFIED SECTION

    Other information

    store at room temperature, USP

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  • INACTIVE INGREDIENT

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

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  • 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®

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  • 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
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  • INGREDIENTS AND APPEARANCE
    BRONCHIAL ASTHMA RELIEF 
    ephedrine hcl, guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-2529
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
    EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    SILICON DIOXIDE  
    STEARIC ACID  
    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)
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