Label: ASTHMANEFRIN - racepinephrine hydrochloride solution

  • NDC Code(s): 0487-2784-01, 0487-2784-10
  • 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 05/13

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

  • SPL UNCLASSIFIED SECTION

    Nephron Pharmaceuticals Corporation

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  • OTC - ACTIVE INGREDIENT

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

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  • OTC - PURPOSE

    Bronchodilator

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  • INDICATIONS AND USAGE

    For temporary relief of mild symptoms of intermittent asthma:

    Wheezing
    Tightness of chest
    Shortness of breath
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  • 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.

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  • OTC - 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.
    If product is brown in color or cloudy
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  • OTC - ASK DOCTOR

    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 enlargement of the prostate gland
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  • OTC - ASK DOCTOR/PHARMACIST

    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).
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  • OTC - STOP USE

    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
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  • OTC - WHEN USING

    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
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  • OTC - PREGNANCY OR BREAST FEEDING

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

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  • OTC - 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.

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  • DOSAGE AND ADMINISTRATION

    Do not use more than directed
    The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
    For use in an atomizer (ie., EZ Breathe Atomizer):
    Add 0.5 ml (contents of one vial) of solution to atomizer.
    Adults and children 4 years of age and over: 1 to 3 inhalations not more than every 3 hours. Start with one inhalation, then wait at least 1 minute. Do not exceed more than 3 inhalations over a 3 hour period. Do not use more than 12 inhalations in a 24 hour period.
    The use of this product by children should be supervised by an adult.
    Children under 4 years of age: Ask a doctor.
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  • HOW SUPPLIED

    Asthmanefrin® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.

    NDC 0487-2784-10 Starter Kit contains 1 EZ Breathe Atomizer and 10 vials, each in an individual foil pouch.

    NDC 0487-2784-01 Refill Carton contains 30 vials, each in an individual foil pouch.

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  • WARNINGS

    Storage and Handling

    Protect from light. Avoid excessive heat. Protect from freezing.
    Store between 2° - 25° C (36° and 77°F).
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  • INACTIVE INGREDIENT

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

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  • OTC - QUESTIONS

    1-855-999-EZAN (3926)

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

    Manufactured By:

    Nephron Pharmaceuticals Corporation

    Orlando, FL  32811

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Foil Pouch

    NDC 0487-2784-10 Starter Kit.

    NDC 0487-2784-01 Refill.

    Asthmanefrin®

    Racepinephrine Inhalation Solution, USP 2.25%

    FOR ORAL INHALATION ONLY

    Drug Facts

    Active Ingredient: Racepinephrine, USP

    Purpose: Bronchodilator

    Each 0.5mL contains 11.25mg (as 13.5mg of Racepinephrine HCl, USP).

    Uses: For temporary relief of mild symptoms of intermittent asthma: Wheezing, Tightness of chest, Shortness of breath

    See product carton for detailed information on Uses, Warnings, and Directions.

    Other Information: Store at room temperature, between 2° - 25°C (36° and 77°F). Protect from light.

    Inactive Ingredients: Ascorbic acid, citric acid, edetate disodium, water for injection.

    TAMPER EVIDENT FEATURE:

    Do not use this product if the pouch is damaged or torn.

    Do not use this product if it is brown in color or cloudy.

    STERILE

    One 0.5mL Unit-of-Use Vial

    465583c3-figure-01

    Principal Display Panel – Carton (Starter Kit -1 EZ Breathe Atomizer and 10 individually wrapped vials)

    NDC 0487-2784-10

    Asthmanefrin®

    Racepinephrine Inhalation Solution, USP 2.25%

    Bronchodilator

    FOR ORAL INHALATION ONLY

    TAMPER EVIDENT FEATURE:

    Do not use this product if the pouch is damaged or torn.

    SULFITE-FREE

    PRESERVATIVE-FREE

    Nephron Pharmaceuticals Corporation

    Orlando, FL 32811

    10 x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

    465583c3-figure-02

    Principal Display Panel – Carton (Refill 30 individually wrapped vials)

    NDC 0487-2784-01

    Asthmanefrin®

    Racepinephrine Inhalation Solution, USP 2.25%

    Bronchodilator

    FOR ORAL INHALATION ONLY

    TAMPER EVIDENT FEATURE:

    Do not use this product if the pouch is damaged or torn.

    SULFITE-FREE

    PRESERVATIVE-FREE

    Nephron Pharmaceuticals Corporation

    Orlando, FL 32811

    30x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

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  • 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 0.5 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:0487-2784-10 10 in 1 CARTON
    1 1 in 1 POUCH
    1 0.5 mL in 1 VIAL, SINGLE-USE
    2 NDC:0487-2784-01 30 in 1 CARTON
    2 1 in 1 POUCH
    2 0.5 mL in 1 VIAL, SINGLE-USE
    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)
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