LEADER SEVERE CONGESTION NASAL- oxymetazoline hydrochloride spray

LEADER SEVERE CONGESTION NASAL by

Drug Labeling and Warnings

LEADER SEVERE CONGESTION NASAL by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                   Purpose

Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

PURPOSE

Uses

• temporarily relieves nasal congestion due to
  
• common cold
• hay fever
• upper respiratory allergies
• sinusitis
• shrinks swollen nasal membranes so you can breathe more freely

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
  
• diabetes
• trouble urinating due to an enlarged prostate gland

WHEN USING

When using this product

• do not use more than directed
• do not use more than 3 days.  Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
• use of this container by more than one person may spread infection

STOP USE

Stop use and ask a doctor if symptoms persist

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Don not exceed 2 doses in any 24-hour period.
• children under 6 years of age : ask a doctor.  To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril.  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use.

STORAGE AND HANDLING

Other information

• store between 15o to 25oC (59o and 77oF)
• retain carton for future reference on full labeling

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3467651

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER SEVERE CONGESTION NASAL 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-336
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-336-10	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/14/2012

Labeler - CARDINAL HEALTH (097537435)