Azelastine Hydrochloride - CVS PHARMACY, INC

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

• nasal congestion
• sneezing
• runny nose
• itchy nose

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray in eyes or mouth.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

• have had recent nose ulcers or nose surgery
• have had nose injury that has not healed

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• an allergic reaction, such as a skin rash, to this product occurs
• you have severe or frequent nosebleeds

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.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

DO NOT USE IF SEALS ON CARTON FLAPS ARE TORN OR OPENED.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

DailyMed Product Concepts#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

• Azelastine Hydrochloride
• Azelastine
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• HYPROMELLOSE, UNSPECIFIED
• SODIUM CITRATE, UNSPECIFIED FORM
• WATER
• SORBITOL
• SUCRALOSE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.