DRISTAN 12 HR- oxymetazoline hydrochloride spray 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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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)

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
DRISTAN 12 HR 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1191
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (clear, colorless to slightly yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1191-201 in 1 CARTON01/01/200406/22/2021
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/200406/22/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 6/2023
Document Id: c2856fde-fdce-408c-8cbf-4bf21ae16d03
Set id: 9ddfb021-fa96-94a6-a413-839ce5a7e744
Version: 8
Effective Time: 20230612
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC