Azelastine HCl

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Azelastine HCl
Generic name
AZELASTINE
Manufacturer
Amneal Pharmaceuticals NY LLC
Product type
HUMAN OTC DRUG
SPL set ID
82610437-25f4-4ae0-9d6a-381e9932f87d
SPL ID
125e35a1-2e6f-4646-aad2-d6465917671c
Version
10
Effective date
2025-11-03
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:45
Harmonized routes table
Harmonized routes
NASAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 have had recent nose ulcers or nose surgery have had a 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 motor vehicle or operation 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 (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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