Label: PRIMATENE- ephedrine hcl, guaifenesin tablet

  • NDC Code(s): 0573-2952-10, 0573-2952-20
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 25, 2021

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

  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Ephedrine HCl, USP 12.5 mg

    Guaifenesin, USP 200 mg

  • PURPOSES

    Bronchodilator

    Expectorant

  • 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
  • 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.

  • DIRECTIONS

    do not take more than directed
    agedose

    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

  • OTHER INFORMATION

    store at 20-25°C (68-77°F)
  • 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

  • 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

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2952-20

    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
  • INGREDIENTS AND APPEARANCE
    PRIMATENE 
    ephedrine hcl, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2952
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE12.5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorYELLOW (Light yellow color) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code P;in;circle;engraved;bisect
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2952-102 in 1 CARTON01/06/200406/30/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2952-205 in 1 CARTON01/06/200406/30/2023
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/06/200406/30/2023
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2952) , LABEL(0573-2952) , MANUFACTURE(0573-2952) , PACK(0573-2952)