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Over-the-counter medicine · no prescription needed

Racepinephrine

Purpose on the label: Bronchodilator

Other medicines

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Racepinephrine used for?
The Drug Facts label of NebuClear MD (Blue Echo Care LLC) lists these uses: For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath.
Do I need a prescription for Racepinephrine?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Racepinephrine been recalled?
FDA enforcement reports list 2 recalls of products on this page; the newest started January 13, 2023. A recall usually concerns specific products or lots, not every brand.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

NebuClear MD · Blue Echo Care LLC

Racepinephrine hydrochloride 11.25 mg/0.5 mL, solution (respiratory (inhalation))

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

Warnings

  • 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.

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. 20 vials, each vial in an individual pouch.

Inactive ingredients

Ascorbic acid, citric acid, edetate disodium, water.

Questions?

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

— FDA label of NebuClear MD, Blue Echo Care LLC, effective May 28, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Racepinephrine hydrochloride 11.25 mg/0.5 mL · solution (respiratory (inhalation)) · 3 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Device - NebuClear MD Hand-held Rubber Bulb Nebulizer Blue Echo Care LLC DailyMed
NebuClear MD Blue Echo Care LLC DailyMed
S2 Nephron Pharmaceuticals Corporation DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. January 13, 2023 · Class II · Terminated · D-0176-2023

    Short Fill

    S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9 — Nephron Sc Inc

  2. June 29, 2022 · Class II · Terminated · D-1325-2022

    CGMP Deviations: products were stored outside the drug label specifications.

    Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals C — Mckesson Medical-Surgical Inc. Corporate Office

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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