Asthmanefrin ®

Asthmanefrin ®
SPL v9
SPL
SPL Set ID 80480838-832c-4fdd-9f8e-f6f877ae3549
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Racepinephrine (11.25 mg)
Inactive Ingredients
Ascorbic Acid Citric Acid Monohydrate Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-01

Description

Drug Facts

Purpose

Bronchodilator

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.


Medication Information

Purpose

Bronchodilator

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.
Description

Drug Facts

Uses

For temporary relief of mild symptoms of intermittent asthma:

  • Wheezing
  • Tightness of chest
  • Shortness of breath
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9

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
Section 50567-7

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.
Section 50568-5

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).
Section 50569-3

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
Section 50570-1

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
Section 53414-9
  • If pregnant or breast-feeding, ask a health professional before use.
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.
Questions?

1-855-999-EZAN (3926)

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

Inactive Ingredients

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

Active Ingredient (in Each 0.5 Ml)

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

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.


Structured Label Content

Uses

For temporary relief of mild symptoms of intermittent asthma:

  • Wheezing
  • Tightness of chest
  • Shortness of breath
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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.
Section 50568-5 (50568-5)

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).
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)
  • If pregnant or breast-feeding, ask a health professional before use.
Purpose

Bronchodilator

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.
Questions?

1-855-999-EZAN (3926)

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

Inactive Ingredients

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

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.
Active Ingredient (in Each 0.5 Ml) (Active ingredient (in each 0.5 ml))

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

Principal Display Panel 0.5 Ml Vial Carton (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.


Advanced Ingredient Data


Raw Label Data

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