PREFERRED PLUS 12 HOUR NASAL ORIGINAL- oxymetazoline hydrochloride spray

Preferred Plus 12 Hour Nasal by

Drug Labeling and Warnings

Preferred Plus 12 Hour Nasal by is a Otc medication manufactured, distributed, or labeled by Kinray, Lee Pharmaceuticals, Samson Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Oxymetazoline Hydrochloride, 0.05%

Purpose

Nasal Decongestant

Uses

• Temporarily relieves sinus congestion and pressure
• Shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• Heart disease
• High blood pressure
• Diabetes
• Thyroid disease
• Trouble urinating due to an enlarged prostate gland

When using this product

• Do not use more than directed
• Do not use for 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 persists.

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.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 6 to under 12 years of age (with adult supervision):  2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age:  ask a doctor
• To spray, squeeze bottle quickly and firmly.  Do not tilt head bacward while spraying.  Wipe nozzle clean after use.

Other information

• Store between 20° to 25°C (68° to 77°F)
• Retain carton for future reference on full labeling

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREFERRED PLUS 12 HOUR NASAL  ORIGINAL
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-048
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	50 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-048-02	1 in 1 CARTON
1	NDC: 61715-048-01	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2008

Labeler - Kinray (012574513)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Kinray		012574513	label(61715-048)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	pack(61715-048)

Establishment
Name	Address	ID/FEI	Business Operations
Samson Pharmaceuticals		088169581	manufacture(61715-048)