Label: ASTHMANEFRIN- racepinephrine hydrochloride solution

  • NDC Code(s): 0487-2784-01
  • Packager: Nephron Pharmaceuticals Corporation
  • 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 12/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each 0.5 ml)

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

    Close
  • Purpose

    Bronchodilator

    Close
  • Uses

    For temporary relief of mild symptoms of intermittent asthma:

    • Wheezing
    • Tightness of chest
    • Shortness of breath
    Close
  • Warnings

    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. In case of overdose, get medical help or contact a Poison Control Center right away.
    Close
  • 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 in 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.
    Close
  • 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: Asthmanefrin ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
      NDC 0487-2784-01 30 vials, each vial in an individual foil pouch.
    Close
  • Inactive Ingredients

    Ascorbic acid, citric acid, edetate disodium, water for injection.

    Close
  • Questions?

    1-855-999-EZAN (3926)

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

    Close
  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    nephron
    pharmaceuticals
    corporation

    Orlando, FL 32811

    Close
  • PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

    Contains 30 ASTHMANEFRIN® vials

    ASTHMANEFRIN ®
    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.

    PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ASTHMANEFRIN 
    racepinephrine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0487-2784
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE 11.25 mg  in .5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBIC ACID  
    CITRIC ACID MONOHYDRATE  
    EDETATE DISODIUM  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0487-2784-01 30 in 1 CARTON
    1 1 in 1 POUCH
    1 .5 mL in 1 VIAL, SINGLE-USE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/01/2012
    Labeler - Nephron Pharmaceuticals Corporation (783905201)
    Registrant - Nephron Pharmaceuticals Corporation (783905201)
    Establishment
    Name Address ID/FEI Business Operations
    Nephron Pharmaceuticals Corporation 783905201 manufacture(0487-2784), analysis(0487-2784), pack(0487-2784)
    Close