Medication-info.com Search Menu

Azelastine Nasal (Astelin): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
137 mcg
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Azelastine Nasal

What is Azelastine hydrochloride Nasal Spray?

  • Azelastine hydrochloride Nasal Spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people age 5 and older and vasomotor rhinitis in people age 12 and older.
  • Azelastine hydrochloride Nasal Spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if Azelastine hydrochloride Nasal Spray is safe and effective in children with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 years of age.

What should I tell my healthcare provider before using Azelastine hydrochloride Nasal Spray?

Before using Azelastine hydrochloride Nasal Spray, tell your healthcare provider if you are:

  • allergic to any of the ingredients in Azelastine hydrochloride Nasal Spray. See the end of this leaflet for a complete list of ingredients in Azelastine hydrochloride Nasal Spray.
  • pregnant, or plan to become pregnant
  • breastfeeding, or plan to breastfeed. It is not known if Azelastine hydrochloride Nasal Spray passes into your breast milk. You and your healthcare provider should decide if you will use Azelastine hydrochloride Nasal Spray if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine hydrochloride Nasal Spray and other medicines may affect each other, causing side effects.

How should I use Azelastine hydrochloride Nasal Spray?

  • Read the Instructions for Use at the end of this leaflet for information about the right way to use Azelastine hydrochloride Nasal Spray.
  • Spray Azelastine hydrochloride Nasal Spray in your nose only. Do not spray it into your eyes or mouth.
  • Use Azelastine hydrochloride Nasal Spray exactly as your healthcare provider tells you to use it.
  • Do not use more than your healthcare provider tells you.
  • Throw away your Azelastine hydrochloride Nasal Spray bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
  • If you use too much or a child accidentally swallows Azelastine hydrochloride Nasal Spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using Azelastine hydrochloride Nasal Spray?

Azelastine hydrochloride Nasal Spray can cause sleepiness:

  • Do not drive, operate machinery, or do other dangerous activities until you know how Azelastine hydrochloride Nasal Spray affects you.
  • Do not drink alcohol or take other medicines that may cause you to feel sleepy while using Azelastine hydrochloride Nasal Spray. It may make your sleepiness worse.

What are the possible side effects of Azelastine hydrochloride Nasal Spray?

The most common side effects of Azelastine hydrochloride Nasal Spray include:

  • unusual bitter taste
  • headache
  • sleepiness
  • nose burning, pain or discomfort
  • runny nose
  • scratchy or sore throat
  • nosebleeds
  • inflammation or swelling of the sinuses
  • sneezing
  • nausea
  • dry mouth
  • fatigue
  • dizziness
  • weight increase

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Azelastine hydrochloride Nasal Spray. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Azelastine hydrochloride Nasal Spray?

  • Keep Azelastine hydrochloride Nasal Spray upright at 68°F to 77°F (20°C to 25°C).
  • Do not freeze Azelastine hydrochloride Nasal Spray.
  • Do not use Azelastine hydrochloride Nasal Spray after the expiration date “EXP” on the medicine label and box.

Keep Azelastine hydrochloride Nasal Spray and all medicines out of reach of children.

General information about the safe and effective use of Azelastine hydrochloride Nasal Spray.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use Azelastine hydrochloride Nasal Spray for a condition for which it was not prescribed. Do not give Azelastine hydrochloride Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Azelastine hydrochloride Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Azelastine hydrochloride Nasal Spray that is written for health professionals.

For more information, call Northstar Rx LLC at 1-800-206-7821.

What are the ingredients in Azelastine hydrochloride Nasal Spray?

Active ingredient: azelastine hydrochloride

Inactive ingredients: benzalkonium chloride, citric acid monohydrate, disodium hydrogen phosphate dodecahydrate, edetate disodium, hypromellose, purified water, and sodium chloride.

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: APL Healthcare Limited

Unit-IV (MP SEZ),

Tirupati (Dt)-524421,

Andhra Pradesh, India.

M.L.No.: 04/NLR/AP/2016/F/CC

Issued: 03/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 212289 · View the label on DailyMed

Revision date stated in the text: March 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Azelastine Nasal

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Histamine-1 Receptor Antagonist
Active ingredient Azelastine hydrochloride 137 mcg
Dosage form Spray, metered
Route Nasal
Marketing status listed in the FDA NDC Directory
Company (applicant) AUROBINDO PHARMA LTD
FDA approval ANDA 212289Abbreviated New Drug Application (ANDA) – generic drug Approved May 8, 2020
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 9 labelers list this drug on DailyMed
Packages (NDC)
Package
137 mcg – 200 in 1 bottle, spray / 1 in 1 carton NDC 72603-611-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.