Astepro Allergy

SPL v8

SPL

SPL Set ID e0640846-19a6-7f79-e053-2995a90a8176

Route

NASAL

Published

Effective Date 2019-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Azelastine (205.5 ug)

Inactive Ingredients

Benzalkonium Chloride Edetate Disodium Hypromelloses Sodium Citrate Sorbitol Sucralose Water

Identifiers & Packaging

Marketing Status

NDA Active Since 2022-06-27

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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

Description

Drug Facts

Uses

Uses

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

nasal congestion
runny nose
sneezing
itchy nose

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 50569-3

Ask a doctor before use if you

have had recent nose ulcers or nose surgery
have had a nose injury that has not healed

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients

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

Section 51945-4

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

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

Questions Or Comments

Questions or comments?

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

Structured Label Content

Uses

Uses

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

nasal congestion
runny nose
sneezing
itchy nose

Warnings and Precautions (34071-1)

Warnings

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you

have had recent nose ulcers or nose surgery
have had a nose injury that has not healed

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

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)

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

Questions Or Comments (Questions or comments)

Questions or comments?

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

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AZELASTINE", "unii": "ZQI909440X", "classCode": "ACTIB", "strengthNumerator": "205.5", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose", "34071-1": "Warnings Only for use in the nose. Do not spray in eyes or mouth.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "50567-7": "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", "50569-3": "Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "51727-6": "Inactive ingredients benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol, sucralose", "51945-4": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)", "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", "Questions or comments": "Questions or comments? 1-800-317-2165 (Mon-Fri, 9AM-5PM EST)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.056060 · Updated: 2026-03-14T23:11:00.469021