S2 RACEPINEPHRINE MULTI-DOSE- racepinephrine hydrochloride solution

S2 Racepinephrine by

Drug Labeling and Warnings

S2 Racepinephrine by is a Otc medication manufactured, distributed, or labeled by Nephron SC, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

Allergy alert

Contains potassium metabisulfite and sodium metabisulfite, sulfites that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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

• 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 a nebulizer:
  Add 0.5 ml (approximately 10 drops) of solution to nebulizer.
• Adults and children 4 years of age and over:
  1 to 3 inhalations not more often than every 3 hours. Start with one inhalation, then wait at least 1 minute. If symptoms do not improve, use once more. Do not exceed more than 3 inhalations over a 3 hour period.
  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: S 2® Racepinephrine Inhalation Solution, 2.25% is supplied in 15 ml amber glass, multi-dose bottles.
  NDC: 0487-5910-01 15 ml amber glass, multi-dose bottle

Inactive Ingredients

Benzoic acid, chlorobutanol, potassium metabisulfite, propylene glycol, sodium chloride, sodium metabisulfite, water for injection.

Questions?

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

PRINCIPAL DISPLAY PANEL - 15 ml Bottle

Principal Dispay - Primary Container Label (15 mL Amber Glass, Multi-Dose Bottle)

NDC: 0487-5910-01

Principal Display - Carton (Individual 15 mL Amber Glass, Multi-Dose Bottle)

NDC: 0487-5910-01

INGREDIENTS AND APPEARANCE

S2 RACEPINEPHRINE  MULTI-DOSE
racepinephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0487-5910
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
POTASSIUM METABISULFITE (UNII: 65OE787Q7W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0487-5910-01	1 in 1 CARTON	08/12/1992
1		15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/12/1992

Labeler - Nephron SC, Inc. (079160190)

Establishment
Name	Address	ID/FEI	Business Operations
Nephron SC, Inc.		079160190	manufacture(0487-5910) , analysis(0487-5910) , pack(0487-5910) , label(0487-5910)