Label: RED LABEL EPHEDRINE PLUS- ephedrine hydrochloride, guaifenesin tablet

  • NDC Code(s): 65193-125-48
  • Packager: Dickey Consumer Products DBA DMD
  • 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 April 2, 2019

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

  • 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)