AFRIN ALLERGY SINUS NASAL- oxymetazoline hydrochloride spray

Afrin Allergy Sinus Nasal by

Drug Labeling and Warnings

Afrin Allergy Sinus Nasal by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

PURPOSE

INDICATIONS & USAGE

Uses

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

OTHER SAFETY INFORMATION

Other information

• store between 20º to 25ºC (68º to 77ºF)
• retain carton for future reference on full labeling

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

QUESTIONS

Questions or comments? 1-800-317-2165

15 mL Carton

Afrin

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Allergy Sinus

Nasal Spray

Fast, Powerful

Congestion

Relief From

Allergies

up to

12 HOUR

RELIEF

Reduces

Swelling of

Nasal

Packages

#1 Doctor &

Pharmacist Recommended

Nasal Spray Brand

1/2 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

AFRIN ALLERGY SINUS NASAL 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0073
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EUCALYPTOL (UNII: RV6J6604TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0073-1	1 in 1 CARTON	08/26/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/26/2016

Labeler - Bayer HealthCare LLC. (112117283)