Active Ingredient (In Each Spray)
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Azelastine Hydrochloride Spray, Metered
FDA Label NDC 0363-0653
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Azelastine Hydrochloride (NDC 0363-0653). 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 active ingredient (in each spray), purpose, uses, warnings, ask a doctor before use if you, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- runny nose
- itchy nose
Warnings
Only for use in the nose. Do not spray in eyes or mouth.
Ask A Doctor Before Use If You
- have had recent nose ulcers or nose surgery
- have had nose injury that has not healed
When Using This Product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying.
- nasal discomfort or sneezing may occur right after use
- do not share this bottle with anyone else as this may spread germs
Stop Use And Ask A Doctor If
- an allergic reaction, such as a skin rash, to this product occurs
- you have severe or frequent nosebleeds
Directions
- Read the User Guide for how to:
- prime the bottle before first use
- use the spray
- prime bottle again if not used for 3 or more days
- clean the spray nozzle if it gets clogged
- once daily: use 2 sprays in each nostril; OR
- twice daily: use 1 or 2 sprays in each nostril every 12 hours
- do not use more than 4 sprays in each nostril in a 24 hour period
- an adult should supervise use
- 1 spray in each nostril every 12 hours
- do not use more than 2 sprays in each nostril in a 24 hour period
| adults and children 12 years and older | This product may be used either once or twice a day: |
| children 6 years to 11 years | |
| children under 6 years | do not use |
Other Information
- store between 20°C to 25°C (68°F to 77°F). Protect from freezing.
- keep this carton and the enclosed User Guide for important information
- do not use if sealed package is torn or opened
Inactive Ingredients
benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose
Questions Or Comments?
call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time
Principal Display Panel - Bottle
Bottle LABEL - PRINCIPAL DISPLAY PANEL
NDC 0363-0653-01
Azelastine Hydrpchloride Nasal Spray (205.5 mcg per spray)
ANTIHISTAMINE NASAL SPRAY
60 Metered Sprays
60mdbtl.jpg (60mdbtl)
Bottle LABEL - PRINCIPAL DISPLAY PANEL
NDC 0363-0653-02
Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)
ANTIHISTAMINE NASAL SPRAY
120 Metered Sprays
120mdbtl.jpg (120mdbtl)
Principal Display Panel - Carton
CARTON LABEL - PRINCIPAL DISPLAY PANEL
NDC 0363-0653-03
Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)
60 Metered Sprays
ANTIHISTAMINE NASAL SPRAY
24 Hour Relief of:
- Nasal congestion
- Runny nose
- Sneezing
- Itchy nose
60mdctn.jpg (60mdctn)
- Nasal congestion
- Runny nose
- Sneezing
- Itchy nose
CARTON LABEL - PRINCIPAL DISPLAY PANEL
NDC 0363-0653-04
Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)
120 Metered Sprays
ANTIHISTAMINE NASAL SPRAY
24 Hour Relief of:
120mdctn.jpg (120mdctn)
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