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FDA LABEL GENERIC: Fluticasone MFR: Haleon US Holdings LLC

Flonase Sensimist 27.5 Mcg/actuat Metered Dose Nasal Spray

Fluticasone furoate 27.5 mcg (glucocorticoid)*

*read the Question & Answer Book

Allergy symptom reliever

INDICATIONS AND USAGE

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)

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. you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. you get an allergic reaction to this product. Seek medical help right away. you get new changes to your vision that develop after starting this product 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.

DOSAGE AND ADMINISTRATION

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
you may start to feel relief the first day and full effect after several days of regular, once-a-day use store between 15° – 30°C (59° – 86°F) do not refrigerate or freeze keep this label and enclosed materials. They contain important additional information.

benzalkonium chloride solution, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, purified water

call toll-free 1-844-FLONASE (1-844-356-6273)

Generic Section

FLONASE SENSIMIST ALLERGY RELIEF

What problems can FLONASE SENSIMIST Allergy Relief help with?

FLONASE SENSIMIST Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes*.

Nasal symptoms

Eye symptoms*

*for ages 12 and older.

These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.

Outdoor allergens

Animal allergens

Indoor allergens

IMPORTANT – Peel here for complete Drug Facts label. Children 2-11: do not use for more than 2 months a year.

Be sure to read the Quick Start Guide and Question & Answer Book inside package

TAMPER-EVIDENT features for your protection. The product is packaged in a sealed plastic container. The bottle is housed within a plastic dispenser that prevents direct access to the bottle. Do not use if the container or any part of the plastic dispenser, including the dispenser bottom, is damaged or broken.

Principal Display Panel

FLONASE

SENSIMIST

ALLERGY RELIEF

Fluticasone Furoate Nasal Spray 27.5 mcg Per Spray Allergy Symptom Reliever (Glucocorticoid)*

Non-Drowsy Relief of:

Nasal congestion itchy, watery eyes Itchy nose Runny nose Sneezing

FULL PRESCRIPTION STRENGTH

24 HOUR RELIEF

120 METERED SPRAYS

*Fluticasone furoate is a steroid medicine known as a glucocorticoid.

0.31 fl oz (9.1 mL)