Label: AZELASTINE HYDROCHLORIDE spray, metered
- NDC Code(s): 69168-479-64
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 2, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Only for use in the nose. Do not spray in eyes or mouth.
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
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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
- Read the User Guide for how to:
- Other information
- Inactive ingredients
- Questions/Comments
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-479 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) AZELASTINE HYDROCHLORIDE 205.5 ug Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-479-64 1 in 1 CARTON 05/02/2025 1 60 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216421 05/02/2025 Labeler - Allegiant Health (079501930)
