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Afrin

MSD Consumer Care, Inc.

Afrin Original Pump Mist


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Afrin Uses

  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • shrinks swollen nasal membranes so you can breathe more freely
  • temporarily relieves sinus congestion and pressure

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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 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.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Afrin Other information

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

Inactive ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

Call 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time, Monday through Friday

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC 11523-1159-1

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Afrin®
Pump Mist

Original
PUMP MIST

Fast, Powerful
Congestion
Relief

Colds • Allergies

12
Hour
Relief

Maximum
Strength

#1 Doctor & Pharmacist
Recommended Brand

1/2 FL OZ (15 mL)

Afrin

Afrin

Oxymetazoline hydrochloride SPRAY, METERED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-1159
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE 0.05 g

Inactive Ingredients

Ingredient Name Strength
EDETATE DISODIUM
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water
SODIUM PHOSPHATE, DIBASIC
sodium phosphate, monobasic
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, PUMP
2 NDC:11523-1159-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1975-07-14


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