ASTHMANEFRIN- racepinephrine hydrochloride solution
Nephron SC, Inc.

Disclaimer: 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.

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ASTHMANEFRIN ®

Drug Facts

Active ingredient (in each 0.5 ml)

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:

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

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

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: Asthmanefrin ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
    NDC 0487-2784-01 30 vials, each vial in an individual foil pouch.

Inactive Ingredients

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

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


West Columbia, SC 29172

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

Contains 30 ASTHMANEFRIN ® vials

ASTHMANEFRIN ®

Racepinephrine Inhalation Solution Bronchodilator

FOR TEMPORARY RELIEF

OF MILD SYMPTOMS OF

INTERMITTENT ASTHMA

Important: Do not exceed recommended dose.

ic-828

ASTHMANEFRIN
racepinephrine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0487-2784
Route of Administration RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F) RACEPINEPHRINE 11.25 mg  in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0487-2784-01 30 in 1 CARTON 08/01/2012
1 1 in 1 POUCH
1 0.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/01/2012
Labeler - Nephron SC, Inc. (079160190)
Registrant - Nephron SC, Inc. (079160190)
Establishment
Name Address ID/FEI Business Operations
Nephron SC, Inc. 079160190 analysis(0487-2784) , pack(0487-2784) , manufacture(0487-2784) , label(0487-2784)

Revised: 10/2019
Document Id: 9627e97a-609c-60cd-e053-2a95a90abaef
Set id: 80480838-832c-4fdd-9f8e-f6f877ae3549
Version: 7
Effective Time: 20191030
Nephron SC, Inc.