DRISTAN 12 HR- oxymetazoline hydrochloride spray

DRISTAN 12 HR by

Drug Labeling and Warnings

DRISTAN 12 HR by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Oxymetazoline hydrochloride 0.05%

PURPOSE

Nasal decongestant

USES

• relieves nasal congestion due to a cold, hay fever or other respiratory allergies
• shrinks swollen membranes
• restores freer breathing through the nose
• relieves sinus congestion and pressure

WARNINGS

For intranasal use only

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

When using this product

• do not exceed recommended dosage
• do not use for more than 3 days
• use only as directed
• frequent or prolonged use may cause nasal congestion to recur or worsen
• you may experience temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
• the use of this container by more than one person may spread infection

Stop use and ask a doctor if

symptoms persist

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• adults and children 12 years and over: with head upright, insert nozzle in nostril. Spray quickly, firmly and sniff deeply. Spray 2 or 3 times into each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period
• children under 12 years: ask a doctor
• children under 2 years: do not use

OTHER INFORMATION

• store at 20-25°C (68-77°F)
• container is filled to proper level for correct spray action
• retain carton for full labeling

INACTIVE INGREDIENTS

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

Dristan®

12
HOUR
NASAL
SPRAY

OXYMETAZOLINE HCl 0.05%
Nasal Decongestant

FAST ACTING

Restores freer nasal breathing
Relieves:

• Nasal congestion due to
  colds & allergies
• Sinus congestion & pressure
• Swelling of nasal passages

0.5 FL OZ (15 ml)

INGREDIENTS AND APPEARANCE

DRISTAN 12 HR 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1191
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	YELLOW (clear, colorless to slightly yellow liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1191-20	1 in 1 CARTON	01/01/2004
1		15 mL in 1 BOTTLE, SPRAY; 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	01/01/2004

Labeler - Wyeth Consumer Healthcare LLC (828831730)