NebuClear MD

RACEPINEPHRINE HYDROCHLORIDE RESPIRATORY (INHALATION) HUMAN OTC DRUG

NebuClear MD is an FDA drug label for the active ingredient RACEPINEPHRINE HYDROCHLORIDE manufactured by Blue Echo Care LLC administered by RESPIRATORY (INHALATION). This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260528.

Generic name
RACEPINEPHRINE HYDROCHLORIDE
Manufacturer
Blue Echo Care LLC
Product type
HUMAN OTC DRUG
Route
RESPIRATORY (INHALATION)
Dosage form
N/A
NDC
73117-523
Application
M012
Label effective
20260528

About this product

NebuClear MD is an FDA-registered drug product whose active ingredient is RACEPINEPHRINE HYDROCHLORIDE. It is labelled by Blue Echo Care LLC taken by respiratory (inhalation) and marketed as a human otc drug product. Identifiers on file: NDC 73117-523, application M012, label effective 20260528. It is one of 2 FDA drug label records sharing the active ingredient RACEPINEPHRINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing RACEPINEPHRINE HYDROCHLORIDE are most often described in connection with: temporary relief, mild symptoms, intermittent asthma, wheezing tightness, chest shortness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

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

Indications & Usage

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

Dosage & Administration

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.

Warnings

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 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.

How products containing RACEPINEPHRINE HYDROCHLORIDE compare

FDA lists 2 drug label records with RACEPINEPHRINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Blue Echo Care LLC 2
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— — — —
— — — —
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Frequently asked questions

What is NebuClear MD used for?
Uses For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath

Who makes NebuClear MD?
Blue Echo Care LLC is the labeler of record for NebuClear MD. 2 FDA label records share the active ingredient RACEPINEPHRINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does NebuClear MD come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is NebuClear MD prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing RACEPINEPHRINE HYDROCHLORIDE?
Yes. 2 FDA drug label records list RACEPINEPHRINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has NebuClear MD been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.