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

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

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Eases breathing for asthma patients by reducing spasms of bronchial muscles.

OTC - DO NOT USE

Warnings

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Do not use this product unless a diagnosis of asthma has been made by a doctor.

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Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a doctor.

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Do not use 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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Do not use this product more frequently or at higher doses than recommended unless directed by a doctor.  Excessive use may cause nervousness and rapid heart beat, and, possibly, adverse effects on the heart.

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Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 20 minutes or become worse.

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

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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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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Inhalation dosage for adults, children 12 years of age and over, and children 4 to under 12 years of age: 1 to 3 inhalations not more often than every 3 hours.

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

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Children under 4 years of age: Consult a doctor.

HOW SUPPLIED

AsthmanefrinTM 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.

Storage and Handling

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Protect from light.  Avoid excessive heat.

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Store at room temperature, between 20° - 25° C (68° and 77°F).

INACTIVE INGREDIENT

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

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

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.