DRISTAN 12 HR NASAL SPRAY- oxymetazoline hydrochloride spray 
Wyeth Consumer Healthcare

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.

----------

DRUG FACTS

ACTIVE INGREDIENT

Oxymetazoline hydrochloride 0.05%

PURPOSE

Nasal decongestant

USE

temporarily relieves nasal congestion due to a cold, hay fever or other upper respiratory allergies

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

OTHER INFORMATION

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

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Dristan

12-hr nasal spray

Nasal Decongestant (Oxymetazoline HCl 0.05%)

fast acting formula

  • Relieves Nasal Congestion due to Colds and Upper Respiratory Allergies

½ FL OZ (15 mL)

Do Not Use if seal imprinted with “Dristan” on bottle neck is broken or missing.

Distributed by: Wyeth Consumer Healthcare Madison, NJ 07940-0871 Made in Canada

Dristan 12-hr nasal spray Packaging
DRISTAN 12 HR NASAL SPRAY 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1191
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oxymetazoline hydrochloride (oxymetazoline) oxymetazoline hydrochloride0.5 mg  in 1 mL
Product Characteristics
ColorYELLOW (clear, colorless to slightly yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-1191-201 in 1 CARTON
115 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2004
Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 06/2009
Document Id: 9ddfb021-fa96-94a6-a413-839ce5a7e744
Set id: 9ddfb021-fa96-94a6-a413-839ce5a7e744
Version: 1
Effective Time: 20090616
 
Wyeth Consumer Healthcare