S2: Package Insert and Label Information

S2- racepinephrine hydrochloride solution
Cardinal Health

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.

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:

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

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 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

Protect from light. Avoid excessive heat. Protect from freezing.
Store between 2°C and 25°C (36°F and 77°F).
How Supplied: S2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.
Available overbagged with 1 x 0.5 mL Sterile Unit-Of-Use Vial, each vial in an individual foil pouch, NDC 55154-4352-8

Inactive Ingredients

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

Questions?

1-800-443-4313

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

Manufactured By:
nephron pharmaceuticals corporation
Orlando, FL 32811

Repackaged By:

Cardinal Health

Zanesville, OH 43701

LA6745-11016

LA6745-21016

Principal Display Panel

S2

Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

1 x 0.5 mL Sterile Unit-of-use Vial

Each in a foil pouch

bag label
(click image for full-size original)
S2
racepinephrine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4352(NDC:0487-5901)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE 11.25 mg in .5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-4352-8 1 POUCH in 1 BAG contains a POUCH
1 1 VIAL, SINGLE-USE in 1 POUCH This package is contained within the BAG (55154-4352-8) and contains a VIAL, SINGLE-USE
1 .5 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a BAG (55154-4352-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2000
Labeler — Cardinal Health (188557102)
Registrant — Nephron Pharmaceuticals Corporation (783905201)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK (55154-4352)

Revised: 01/2018 Cardinal Health

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