Nephron Pharmaceuticals Corporation

OTC - ACTIVE INGREDIENT

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

OTC - PURPOSE

Bronchodilator

INDICATIONS AND USAGE

For temporary relief of mild symptoms of intermittent asthma:

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Wheezing

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Tightness of chest

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Shortness of breath

WARNINGS

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

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Are not better in 20 minutes

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Get worse

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Need more than 12 inhalations in 24 hours

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Use more than 9 inhalations in 24 hours for 3 or more days a week

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Have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

OTC - DO NOT USE

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Unless a doctor said you have asthma

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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.

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If product is brown in color or cloudy

OTC - ASK DOCTOR

Ask a doctor before use if you have:

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Ever been hospitalized for asthma

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Heart disease

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High blood pressure

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Diabetes

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Thyroid disease

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Seizures

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Narrow angle glaucoma

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A psychiatric or emotional condition

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Trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are:

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Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.

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Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

OTC - STOP USE

Stop use and ask a doctor if:

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Your asthma is getting worse (See Asthma Alert)

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You have difficulty sleeping

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You have a rapid heartbeat

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You have tremors, nervousness, or seizure

OTC - WHEN USING

When using this product:

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Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

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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.

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Avoid foods or beverages that contain caffeine.

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Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.

OTC - PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE AND ADMINISTRATION

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Do not use more then directed.

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The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.

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For use in an atomizer (ie., EZ Breathe Atomizer).

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Add 0.5 ml (contents of one vial) of solution to atomizer.

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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.

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Children under 4 years of age: ask a doctor.

HOW SUPPLIED

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

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

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

INACTIVE INGREDIENT

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

OTC – QUESTIONS?

Call 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Foil Pouch

NDC 0487-2784-10 Starter Kit.

NDC 0487-2784-01 Refill.

AsthmanefrinTM

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 shortness of breath, tightness of chest, and wheezing due to bronchial asthma.

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

Other Information: Store at room temperature, between 20° - 25°C (68° 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

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

NDC 0487-2784-10

AsthmanefrinTM

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

Neprhon Pharmaceuticals Corporation

Orlando, FL 32811

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

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

NDC 0487-2784-01

AsthmanefrinTM

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

Neprhon Pharmaceuticals Corporation

Orlando, FL 32811

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