Label: NEBUCLEAR MD- racepinephrine liquid
- NDC Code(s): 73117-519-18
- Packager: Blue Echo Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 24, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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.
- KEEP OUT OF REACH OF CHILDREN
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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.
- Other Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
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INGREDIENTS AND APPEARANCE
NEBUCLEAR MD
racepinephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73117-519 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (EPINEPHRINE,(+/-)- - UNII:GR0L9S3J0F) EPINEPHRINE,(+/-)- 11.25 mg in 0.5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73117-519-18 20 mL in 1 BOX; Type 0: Not a Combination Product 09/20/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/20/2025 Labeler - Blue Echo Care LLC (117048847) Establishment Name Address ID/FEI Business Operations Blue Echo Care LLC 117048847 manufacture(73117-519)

