Drugplain

FLONASE SENSIMIST ALLERGY RELIEF 27.5 ug/1

fluticasone furoate · SPRAY, METERED · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

FLONASE SENSIMIST ALLERGY RELIEF is a spray, metered containing fluticasone furoate at 27.5 ug/1, taken nasal. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
FLONASE SENSIMIST ALLERGY RELIEF
Generic Name
fluticasone furoate
NDC Code (Product)
0135-0615
Manufacturer
Haleon US Holdings LLC
Strength
27.5 ug/1
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
NDA022051
Marketing Start
02/01/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,571 reports
dyspnoea977 reports
asthma828 reports
off label use827 reports
macular degeneration605 reports
wheezing595 reports
pain587 reports
nausea583 reports
therapeutic product effect incomplete554 reports
headache535 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes (for ages 12 and older)

Dosage & Administration

Directions • read the Quick Start Guide for how to: • shake vigorously before each use • prime the bottle • use the spray • sniff gently after each spray • clean the spray nozzle with a clean dry tissue • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 2 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 2 YEARS OF AGE • do not use

Warnings

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • yo

Frequently Asked Questions

What is FLONASE SENSIMIST ALLERGY RELIEF used for?

FLONASE SENSIMIST ALLERGY RELIEF contains fluticasone furoate. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is FLONASE SENSIMIST ALLERGY RELIEF a controlled substance?

FLONASE SENSIMIST ALLERGY RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for FLONASE SENSIMIST ALLERGY RELIEF?

The generic name for FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are 10 other brand versions of fluticasone furoate.

What is the NDC code for FLONASE SENSIMIST ALLERGY RELIEF 27.5 ug/1?

The NDC (National Drug Code) for FLONASE SENSIMIST ALLERGY RELIEF 27.5 ug/1 is 0135-0615, listed by Haleon US Holdings LLC.