Azelastine Hydrochloride Spray, Metered
FDA Label NDC 69168-478

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Azelastine Hydrochloride (NDC 69168-478). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use if you have, ask a doctor before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use If You Have

→ Ask A Doctor Before Use If You

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breastfeeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions/comments

→ Principal Display Panel

Active Ingredient(S)

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

Antihistamine

Use(S)

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

nasal congestion
runny nose
sneezing
itchy nose

Warnings

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

Do Not Use If You Have

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 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.

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 spraysin 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 spraysin each nostril in a 24 hour period
children under 6 years	do not use