479 - Azelastine Hydrochloride
cc7ddac6-95fa-4bc0-824d-f80e404e8d32
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Use(s)
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.
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
adults and children 12 years and older:
This product may be used either once or twice a day:
- 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
children 6 years to 11 years:
- 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
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
Questions/comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Active Ingredient(s)
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Inactive Ingredients
benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose
Do Not Use If You Have
ever had an allergic reaction to this product or any of its ingredients
Principal Display Panel
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
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Ask A Doctor Before Use If You
- have had recent nose ulcers or nose surgery
- have had nose injury that has not healed
Structured Label Content
Use(s)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- runny nose
- itchy nose
Purpose
Antihistamine
Warnings
Only for use in the nose. Do not spray in eyes or mouth.
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
adults and children 12 years and older:
This product may be used either once or twice a day:
- 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
children 6 years to 11 years:
- 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
children under 6 years: do not use
Other Information (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
Questions/comments (Questions/Comments)
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Active Ingredient(s) (Active ingredient(s))
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Inactive Ingredients (Inactive ingredients)
benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose
Do Not Use If You Have (Do not use if you have)
ever had an allergic reaction to this product or any of its ingredients
Principal Display Panel
When Using This Product (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 (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
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)
ask a health professional before use.
Keep Out of Reach of Children (Keep out of reach of children)
In case of overdose, get medical help or contact a Poison Control Center right away.
Ask A Doctor Before Use If You (Ask a doctor before use if you)
- have had recent nose ulcers or nose surgery
- have had nose injury that has not healed
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:29.090328 · Updated: 2026-03-14T23:09:16.713853