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Drug Facts
Afrin Allergy Sinus Nasal Spray
FDA Label NDC 11523-0073
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Afrin Allergy Sinus Nasal (NDC 11523-0073). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient Purpose
Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant
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
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 20° to 25°C (68° to 77°F)
- 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
Otc - 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)
Carton 15 mL (85496999 15ml 1 Ctn)
* Please review the disclaimer below.
