Label: PRIMATENE- ephedrine hydrochloride and guaifenesin tablet

  • NDC Code(s): 0573-2952-10, 0573-2952-20
  • Packager: Pfizer Consumer Healthcare
  • 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Ephedrine HCl, USP 12.5 mg

    Guaifenesin, USP 200 mg

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  • PURPOSES

    Bronchodilator

    Expectorant

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  • 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 bronchial passageways of bothersome mucus, and to 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 more than 12 tablets in 24 hours
    • use more than 8 tablets in 24 hours for 3 or more days a week
    • have more than 2 asthma attacks in a week

    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 taken 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.

    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
    • 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 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)

    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 is accompanied by 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

    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.

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  • DIRECTIONS

    • do not take more than directed
    age dose
    adults and children 12 years of age and over oral dose is 1-2 tablets (12.5 to 25 mg) every 4 hours as needed. Do not take more than 12 tablets (150 mg) in 24 hours
    children under 12 years of age ask a doctor
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  • OTHER INFORMATION

    • store at 20-25°C (68-77°F)
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  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone

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  • QUESTIONS OR COMMENTS?

    Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

    For most recent product information, visit www.PrimateneTablets.com

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  • PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

    Primatene®
    TABLETS

    Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant
    Helps Loosen Phlegm (Mucus)

    For the Temporary Relief of Mild Symptoms of
    INTERMITTENT ASTHMA

    60 TABLETS

    Principal Display Panel - 60 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    PRIMATENE 
    ephedrine hcl, guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-2952
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE 12.5 mg
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSPOVIDONE  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    Product Characteristics
    Color YELLOW (Light yellow color) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code P;in;circle;engraved;bisect
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2952-10 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:0573-2952-20 5 in 1 CARTON
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/06/2004
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company, Consumer Site 829390975 ANALYSIS(0573-2952), LABEL(0573-2952), MANUFACTURE(0573-2952), PACK(0573-2952)
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