Your browser does not support JavaScript! ASTHMANEFRIN (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

ASTHMANEFRIN (racepinephrine hydrochloride) solution
[Nephron Pharmaceuticals Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Nephron Pharmaceuticals Corporation

OTC - ACTIVE INGREDIENT

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

OTC - PURPOSE

Bronchodilator

INDICATIONS AND USAGE

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.

OTC - 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 an MAOI, ask a doctor or pharmacist before taking this product.
If product is brown in color or cloudy

OTC - ASK DOCTOR

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 enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST

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

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

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

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

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

DOSAGE AND ADMINISTRATION

Do not use more than directed
The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
For use in an atomizer (ie., EZ Breathe Atomizer):
Add 0.5 ml (contents of one vial) of solution to atomizer.
Adults and children 4 years of age and over: 1 to 3 inhalations not more than every 3 hours. Start with one inhalation, then wait at least 1 minute. Do not exceed more than 3 inhalations over a 3 hour period. Do not use more than 12 inhalations in a 24 hour period.
The use of this product by children should be supervised by an adult.
Children under 4 years of age: Ask a doctor.

HOW SUPPLIED

Asthmanefrin® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.

NDC 0487-2784-10 Starter Kit contains 1 EZ Breathe Atomizer and 10 vials, each in an individual foil pouch.

NDC 0487-2784-01 Refill Carton contains 30 vials, each in an individual foil pouch.

Storage and Handling

Protect from light. Avoid excessive heat. Protect from freezing.
Store between 2° - 25° C (36° and 77°F).

INACTIVE INGREDIENT

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

OTC - QUESTIONS

1-855-999-EZAN (3926)

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

Manufactured By:

Nephron Pharmaceuticals Corporation

Orlando, FL  32811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Foil Pouch

NDC 0487-2784-10 Starter Kit.

NDC 0487-2784-01 Refill.

Asthmanefrin®

Racepinephrine Inhalation Solution, USP 2.25%

FOR ORAL INHALATION ONLY

Drug Facts

Active Ingredient: Racepinephrine, USP

Purpose: Bronchodilator

Each 0.5mL contains 11.25mg (as 13.5mg of Racepinephrine HCl, USP).

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

See product carton for detailed information on Uses, Warnings, and Directions.

Other Information: Store at room temperature, between 2° - 25°C (36° and 77°F). Protect from light.

Inactive Ingredients: Ascorbic acid, citric acid, edetate disodium, water for injection.

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

Do not use this product if it is brown in color or cloudy.

STERILE

One 0.5mL Unit-of-Use Vial

465583c3-figure-01

Principal Display Panel – Carton (Starter Kit -1 EZ Breathe Atomizer and 10 individually wrapped vials)

NDC 0487-2784-10

Asthmanefrin®

Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

10 x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

465583c3-figure-02

Principal Display Panel – Carton (Refill 30 individually wrapped vials)

NDC 0487-2784-01

Asthmanefrin®

Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

30x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

465583c3-figure-03
465583c3-figure-04
465583c3-figure-05
ASTHMANEFRIN 
racepinephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0487-2784
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE11.25 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0487-2784-1010 in 1 CARTON
11 in 1 POUCH
10.5 mL in 1 VIAL, SINGLE-USE
2NDC:0487-2784-0130 in 1 CARTON
21 in 1 POUCH
20.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2012
Labeler - Nephron Pharmaceuticals Corporation (783905201)
Registrant - Nephron Pharmaceuticals Corporation (783905201)
Establishment
NameAddressID/FEIBusiness Operations
Nephron Pharmaceuticals Corporation783905201MANUFACTURE(0487-2784), ANALYSIS(0487-2784), PACK(0487-2784)

Revised: 5/2013
 
Nephron Pharmaceuticals Corporation

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services