Astepro Allergy: Package Insert / Prescribing Information - Drugs.com

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# Astepro Allergy

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

Medically reviewed by Drugs.com. Last updated on Jun 1, 2022.

Drug Facts

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

Antihistamine

## Uses

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.

## Directions

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 years | do 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)

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 Type | HUMAN OTC DRUG | Item Code (Source) | NDC:0280-0065
Route of Administration | NASAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
AZELASTINE HYDROCHLORIDE (AZELASTINE) | AZELASTINE HYDROCHLORIDE | 205.5 ug

Inactive Ingredients
Ingredient Name | Strength
BENZALKONIUM CHLORIDE |
EDETATE DISODIUM |
HYPROMELLOSES |
SODIUM CITRATE |
SORBITOL |
SUCRALOSE |
WATER |

Packaging
# | Item Code | Package Description
1 | NDC:0280-0065-10 | 22 CARTON in 1 BOTTLE
1 |  | 1 SPRAY, METERED in 1 CARTON
2 | NDC:0280-0065-03 | 120 PACKAGE in 1 BOTTLE
2 |  | 3 SPRAY, METERED in 1 PACKAGE
3 | NDC:0280-0065-01 | 60 CARTON in 1 BOTTLE
3 |  | 1 SPRAY, METERED in 1 CARTON
4 | NDC:0280-0065-02 | 120 CARTON in 1 BOTTLE
4 |  | 1 SPRAY, METERED in 1 CARTON
5 | NDC:0280-0065-04 | 200 CARTON in 1 BOTTLE
5 |  | 1 SPRAY, METERED in 1 CARTON
6 | NDC:0280-0065-09 | 120 CARTON in 1 BOTTLE
6 |  | 2 SPRAY, METERED in 1 CARTON

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
NDA | NDA213872 | 06/27/2022 |

Labeler - Bayer HealthCare LLC. (112117283)

Bayer HealthCare LLC.

## More about Astepro Allergy (azelastine nasal)

- Check interactions
- Side effects
- Dosage information
- During pregnancy
- Drug class: nasal antihistamines and decongestants
- Breastfeeding

### Professional resources

- Prescribing Information

#### Other brands

Astelin, Astepro

### Related treatment guides

- Allergic Rhinitis

Medical Disclaimer