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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Children Astepro Allergy (NDC 0280-0066). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient
Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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
When using this product
Stop use and ask a doctor if
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.
Read the User Guide for how to:
| adults and children 12 years and older | This product may be used either once or twice a day:
|
children 6 years to 11 years |
|
| children under 6 years | do not use |
Other information
Inactive ingredients
benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol, sucralose
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
* Please review the disclaimer below.