Active ingredient

Manufacturer
Blue Echo Care LLC
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-03 18:03:26

Label at a glance#

ProductNebuClear MD
Active ingredientRACEPINEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath

Dosage and administration

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 childr...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Bronchodilator

Uses

INDICATIONS & USAGE SECTION

For temporary relief of mild symptoms of intermittent asthma:

Wheezing
Tightness of chest
Shortness of breath

Warning

WARNINGS SECTION

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
  • If its color is pinkish or darker than slightly yellow or if it contains a precipitate.

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

:Ascorbic acid, citric acid, edetate disodium, water.

Questions

OTC - QUESTIONS SECTION

1 (855) 860-3404

support@blueechocare.com

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

Manufactured For:


Blue Echo Care LLC
3639 SE 21st Ave

Portland, OR 97202 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display - Pouch Label (Individually Wrapped Vial)

NDC: 73117-523-19

NebuClear MD foil WrapperNebuClear MD foil Wrapper

Principle Display - Carton (20 Individually Wrapped Vials)


NDC: 73117-523-19

NebuClear MD packagingNebuClear MD packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310133racepinephrine 2.25 % Inhalation SolutionPSN2
310133racepinephrine 22.5 MG/ML Inhalation SolutionSCD2
310133racepinephrine 11.25 MG per 0.5 ML Inhalation SolutionSY2
310133racepinephrine 2.25 % Inhalation SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130732388434282GTIN-13: 0732388434282
EAN-13: 0732388434282
GTIN-12: 732388434282
UPC-A: 732388434282
GTIN storage (14 digits): 00732388434282
foil jpg nebuclear 40 vials racepinephrine v2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73117-52373117-523-19
73117-509

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-13full-release2026-06-01 01:57:20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
ndc (product): 73117-523
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
ndc (package): 73117-523-19
ndc (product): 73117-523
ndc11 (package): 73117052319
spl id: 52e51585-8275-0cca-e063-6394a90aa742
spl set id: 51badd2f-4a43-3dbe-e063-6294a90a4bd1
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
ndc (product): 73117-509

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.