RED LABEL EPHEDRINE PLUS (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]

RED LABEL EPHEDRINE PLUS (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]
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NDC 65193-125-48
Set ID bc11389f-c988-4f67-a56e-6eaad5cb1883
Category HUMAN OTC DRUG LABEL
Packager Dickey Consumer Products DBA DMD
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient(In Each Tablet): Ephedrine HCl 12.5 mg, Guaifenesin 200 mg

  • PURPOSE

    Purposes - Bronchodilator, Expectorant

  • INDICATIONS & USAGE

    • 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 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 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)

    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 claim to have a stimulant effect.  

    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 seizures • cough lasts more than 1 week, comes back, or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health proffessional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • do not take more than directed  • adults and children 12 years of age and over: oral dose is 1-2 tablets every 4 hours as needed, do not take more than 12 tablets in 24 hours • children under 12 years of age: do not use

  • INACTIVE INGREDIENT

    Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    Red Label Ephededrine Plus 48ctRed Label Ephededrine Plus 48ctRed Label Ephededrine Plus 48ct

  • INGREDIENTS AND APPEARANCE
    RED LABEL EPHEDRINE PLUS 
    ephedrine hydrochloride, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-125
    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
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (EP125) Size9mm
    FlavorImprint Code EP125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65193-125-4848 in 1 BLISTER PACK; Type 0: Not a Combination Product04/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/02/2019
    Labeler - Dickey Consumer Products DBA DMD (835974056)
    Registrant - Dickey Consumer Products DBA DMD (835974056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(65193-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corp.085752004pack(65193-125)

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