DailyMed - AZELASTINE HYDROCHLORIDE spray, metered

NDC Code(s): 0363-0653-01, 0363-0653-02, 0363-0653-03, 0363-0653-04
Packager: Walgreens

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 28, 2025

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Active ingredient (in each spray)
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
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Purpose
Antihistamine

Antihistamine
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Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion - runny nose - runny nose - itchy nose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- runny nose
- itchy nose
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Warnings
Only for use in the nose. Do not spray in eyes or mouth. Do not use if you have ever had an allergic reaction to this product or any of its ingredients - Ask a doctor before use if ...
Only for use in the nose. Do not spray in eyes or mouth.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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
If pregnant or breast-feeding, 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.

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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 ...

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
- 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
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Inactive ingredients
benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose

benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose
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Questions or comments?
call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time
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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

Bottle LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-01

Azelastine Hydrpchloride Nasal Spray (205.5 mcg per spray)

ANTIHISTAMINE NASAL SPRAY

60 Metered Sprays

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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 ...
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
Close
Principal Display Panel - Bottle
Bottle LABEL - PRINCIPAL DISPLAY PANEL - NDC 0363-0653-02 - Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray) ANTIHISTAMINE NASAL SPRAY - 120 Metered Sprays

Bottle LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-02

Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)

ANTIHISTAMINE NASAL SPRAY

120 Metered Sprays

Close
Principal Display Panel - Carton
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: Nasal ...
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:
- Nasal congestion
- Runny nose
- Sneezing
- Itchy nose
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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc.		255092496	analysis(0363-0653) , manufacture(0363-0653)

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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

Published Date (What is this?)	Version	Files
Mar 31, 2025	2 (current)	download
Jun 27, 2024	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	PSN
2	1797883	azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray	SCD
3	1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	SY

Label: AZELASTINE HYDROCHLORIDE spray, metered

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Drug Label Information

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	NDC
1	0363-0653-01
2	0363-0653-02
3	0363-0653-03
4	0363-0653-04

Label: AZELASTINE HYDROCHLORIDE spray, metered

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

AZELASTINE HYDROCHLORIDE spray, metered

Number of versions: 2

AZELASTINE HYDROCHLORIDE spray, metered

AZELASTINE HYDROCHLORIDE spray, metered

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AZELASTINE HYDROCHLORIDE spray, metered

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.