FDA.reportPublic FDA data

Racepinephrine Inhalation Solution, USP 2.25%

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-02-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:51:04

Label at a glance#

ProductRacepinephrine
Active ingredientRACEPINEPHRINE HYDROCHLORIDE
Label structure11 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 in 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 chil...

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: S 2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials. NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 0.5 ml)

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

Warnings

WARNINGS SECTION

Asthma alert

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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).

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • 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 in 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

STORAGE AND HANDLING SECTION

  • Protect from light. Avoid excessive heat. Protect from freezing.
  • Store between 2°C and 25°C (36°F and 77°F).
  • How Supplied: S 2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.

    NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ascorbic acid, citric acid, edetate disodium, water for injection.

Questions?

OTC - QUESTIONS SECTION

1-800-443-4313

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

SPL UNCLASSIFIED SECTION

Manufactured By:

Nephron Pharmaceuticals Corporation

West Columbia, SC 29172

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5149-32024-06-20C16284748780-1f386c649-c510-0266-e053-dadaa90a7c1aRacepinephrine Inhalation Solution, USP 2.25%
68071-5149-32023-01-30C16284748780-1f386c649-c510-0266-e053-dadaa90a7c1aRacepinephrine Inhalation Solution, USP 2.25%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-5901-02EA - Each0487-5901e4fa89c2-def9-4c41-9c97-ccaf02f5b5cf12012-07-24
0487-5901-10EA - Each0487-59014e462d6e-f2d0-4ea7-bcfa-2073e6f5109f12013-02-13
0487-5901-99EA - Each0487-5901530e7c42-5bd7-483e-96d6-682b76349b3312012-07-24

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-514968071-5149-3
0487-5901

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
RACEPINEPHRINE HYDROCHLORIDE336096P2WEACTIM

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
ndc (product): 0487-5901
1b54f27a-f43a-ab53-e063-6394a90a9ee89c49660a-7545-e4e7-e053-2995a90a85482024-06-20WarningsExact identifier
spl set id: 9c49660a-7545-e4e7-e053-2995a90a8548

Reported adverse events (FAERS/openFDA)#

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