Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 22d516d0-da22-4e3b-a4a5-135b009bc968
Route
NASAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Azelastine (205.5 ug)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Hypromellose, Unspecified Sodium Citrate, Unspecified Form Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-08-01
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)

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • nasal congestion
  • sneezing
  • 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
Do Not Use

 if you have ever had an allergic reaction to this product or any of its ingredients

Package Label
CVS Allergy Relief Nasal Spray
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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to Astepro® Allergy active ingredient*

Full prescription Strength

ALLERGY RELIEF

Nasal Spray

Azelastine Hydrochloride

205.5 mcg per spray, Antihistamine

Up to 24-hour relief of

Nasal congestion

Runny nose

Sneezing

Itchy nose

STEROID FREE | ALCOHOL FREE | FRAGRANCE FREE

METERED SPRAYS 

Indoor & Outdoor Allergy Relief

FL OZ (mL)

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Astepro® Allergy Spray.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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
Ask A Doctor Before Use If You
  • have had recent nose ulcers or nose surgery
  • have had nose injury that has not healed
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 (1-800-222-1222) right away.

Active Ingredient (in Each Spray)

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • nasal congestion
  • sneezing
  • 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
Do Not Use (Do not use)

 if you have ever had an allergic reaction to this product or any of its ingredients

Package Label (Package label)
CVS Allergy Relief Nasal Spray
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
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (Principal display panel)

*Compare to Astepro® Allergy active ingredient*

Full prescription Strength

ALLERGY RELIEF

Nasal Spray

Azelastine Hydrochloride

205.5 mcg per spray, Antihistamine

Up to 24-hour relief of

Nasal congestion

Runny nose

Sneezing

Itchy nose

STEROID FREE | ALCOHOL FREE | FRAGRANCE FREE

METERED SPRAYS 

Indoor & Outdoor Allergy Relief

FL OZ (mL)

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Astepro® Allergy Spray.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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
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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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 (1-800-222-1222) right away.

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:06.910758 · Updated: 2026-03-14T23:12:15.627416