Medication Guide App

DRISTAN 12 HR

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-1191

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.

Dristan 12-hr Nasal Spray
(oxymetazoline hydrochloride)

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

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

Dristan®
12-hr nasal spray
OXYMETAZOLINE HCl 0.05% (Nasal Decongestant)

fast acting formula

  • Relieves Nasal
    Congestion due to Colds
    and Upper Respiratory
    Allergies

1/2 FL OZ (15 ml)

DRISTAN 12 HR 
oxymetazoline hydrochloride 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
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, DIBASIC 
HYPROMELLOSES 
PHOSPHORIC ACID 
WATER 
SODIUM CHLORIDE 
EDETATE DISODIUM 
Product Characteristics
ColorYELLOW (clear, colorless to slightly yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-1191-201 BOTTLE, SPRAY 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 - Pfizer Consumer Healthcare (828831730)

Revised: 02/2013
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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