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Astepro Allergy Prescribing Information

Package insert / product label
Generic name: azelastine hydrochloride
Dosage form: nasal spray, metered
Drug class: Nasal antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Sep 27, 2023.

Drug Facts

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

Antihistamine

Indications and Usage for Astepro Allergy

Uses

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 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 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 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 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.

Astepro Allergy Dosage and Administration

Read the User Guide for how to:

  • prime the bottle before first use
  • prime bottle again if not used for 3 or more days
  • use the spray
  • 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 yearsdo not use

Other information

Other information

  • store between 20° to 25° C (68° to 77° F). Protect from freezing.
  • keep this carton and the enclosed User Guide for important information
  • do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact

Inactive ingredients

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

Questions or comments

Questions or comments?

1-800-317-2165 (Mon-Fri, 9AM-5PM EST)

Astepro-120-Artwork

Azelastine HCl 205.5 mcg per spray

ANTIHISTAMINE NASAL SPRAY

FULL PRESCRIPTION STRENGTH

STEROID FREE

UP TO 24 HOUR RELIEF OF

Nasal congestion
Runny nose
Sneezing
Itchy nose

ASTEPRO ALLERGY
azelastine hcl spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0065
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) AZELASTINE HYDROCHLORIDE205.5 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0065-1022 in 1 BOTTLE07/05/2022
11 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0280-0065-03120 in 1 BOTTLE07/05/2022
23 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0280-0065-0160 in 1 BOTTLE07/05/2022
31 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:0280-0065-02120 in 1 BOTTLE07/05/2022
41 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:0280-0065-04200 in 1 BOTTLE07/05/2022
51 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6NDC:0280-0065-09120 in 1 BOTTLE07/05/2022
62 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
7NDC:0280-0065-0522 in 1 BOTTLE01/24/2023
71 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21387206/27/2022
Labeler - Bayer HealthCare LLC. (112117283)

Medical Disclaimer