Label: NEBUCLEAR MD- racepinephrine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 24, 2025

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

  • Active ingredient

    Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

  • Purpose

    Bronchodilator

  • Uses

    For temporary relief of mild symptoms of intermittent asthma:

    Wheezing
    Tightness of chest
    Shortness of breath

  • Warning

    Asthma alert: Because asthma may be life threatening, see a doctor if you:

    • Are not better in 20 minutes
    • Get worse
    • Need more than 12 inhalations in 24 hours
    • Use more than 9 inhalations 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.

    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 a MAOI, ask a doctor or pharmacist before taking this product.
    • If product is brown in color or cloudy

    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

    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 heartbeat
    • You have tremors, nervousness, or seizure

    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

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

  • Directions

    • The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
    • Do not use more than directed
    • For use with a hand-held rubber bulb Nebulizer.
    • Add 0.5 mL (contents of one vial) of solution to Nebulizer.
    • Adults and children 4 years of age and over:

    1 to 3 inhalations not more often than every 3 hours.

    Do not use more than 12 inhalations in 24 hours.

    The use of this product by children should be supervised by an adult.

    • Children under 4 years of age: ask a doctor.
  • Other Information

    Storage and Handling

    Protect from light. Avoid excessive heat. Protect from freezing.
    Store between 2°C and 25°C (36°F and 77°F).
    How Supplied: NebuClear MD® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
    20 vials, each vial in an individual pouch.

  • Inactive Ingredients

    Ascorbic acid, citric acid, edetate disodium, water.

  • Questions

    1 (855) 860-3404

    support@blueechocare.com

    Monday through Friday, 8:00 a.m. to 5:00 p.m. (Pacific Standard Time).

    Manufactured By:


    Blue Echo Care LLC
    3639 SE 21st Ave

    Portland, OR 97202 USA

  • PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

    Contains 20 NebuClear MD® Racepinephine vials

    Racepinephine

    Racepinephrine Inhalation Solution Bronchodilator

    FOR TEMPORARY RELIEF

    OF MILD SYMPTOMS OF

    INTERMITTENT ASTHMA

    • Shortness of breath
    • Tightness of chest
    • Wheezing

    Important: Do not exceed recommended dose.

    NebuClear MD Packaging

  • INGREDIENTS AND APPEARANCE
    NEBUCLEAR MD 
    racepinephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73117-519
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (EPINEPHRINE,(+/-)- - UNII:GR0L9S3J0F) EPINEPHRINE,(+/-)-11.25 mg  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73117-519-1820 mL in 1 BOX; Type 0: Not a Combination Product09/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/20/2025
    Labeler - Blue Echo Care LLC (117048847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Echo Care LLC117048847manufacture(73117-519)