NebuClear MD — v3

NebuClear MD

4 Views

Version

v3

Effective date

September 24, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
3f862ae1-8a67-e0ee-e063-6294a90ab3e8
Set ID
3598ac5b-29f9-f002-e063-6294a90a62cb
Application numbers
M012
Product NDCs
73117-519
Package NDCs
73117-519-18
Original packager NDCs

Names & Manufacturers

Brand names
NebuClear MD
Generic names
RACEPINEPHRINE
Manufacturer names
Blue Echo Care LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
RACEPINEPHRINE HYDROCHLORIDE
Routes
RESPIRATORY (INHALATION)
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
310133
UNII
336096P2WE
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).
Dosage And Administration (1)

Sequence 1

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 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.
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients Ascorbic acid, citric acid, edetate disodium, water.
Indications And Usage (1)

Sequence 1

Uses For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

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. 20 vials, each vial in an individual pouch.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton Contains 20 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. NebuClear MD Packaging
Purpose (1)

Sequence 1

Purpose Bronchodilator
Questions (1)

Sequence 1

Questions 1 (855) 860-3404 support@blueechocare.com 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
Spl Product Data Elements (1)

Sequence 1

NebuClear MD Racepinephrine WATER EDETATE DISODIUM RACEPINEPHRINE HYDROCHLORIDE EPINEPHRINE,(+/-)- ASCORBIC ACID CITRIC ACID MONOHYDRATE
Warnings (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['NebuClear MD'],
 'generic_name': ['RACEPINEPHRINE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Blue Echo Care LLC'],
 'package_ndc': ['73117-519-18'],
 'product_ndc': ['73117-519'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['RESPIRATORY (INHALATION)'],
 'rxcui': ['310133'],
 'spl_id': ['3f862ae1-8a67-e0ee-e063-6294a90ab3e8'],
 'spl_set_id': ['3598ac5b-29f9-f002-e063-6294a90a62cb'],
 'substance_name': ['RACEPINEPHRINE HYDROCHLORIDE'],
 'unii': ['336096P2WE']}