FDA Label for Nebuclear Md

Active Ingredient

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

Purpose

Bronchodilator

Uses

For temporary relief of mild symptoms of intermittent asthma:

Wheezing
Tightness of chest
Shortness of breath

Warning

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.

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.

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 with a Jet or Ultrasonic 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.

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: NebuClear MD® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
30 vials, each vial in an individual pouch.

Inactive Ingredients

Ascorbic acid, citric acid, edetate disodium, water.

Questions

1 (855) 860-3404

[email protected]

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

Manufactured By:

Blue Echo Care LLC
3639 SE 21st Ave

Portland, OR 97202 USA

Principal Display Panel - 0.5 Ml Vial Carton

Contains 30 NebuClear MD® Racepinephine vials

Racepinephine

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.