FDA Label for Flonase Sensimist Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SPRAY)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- HOW SUPPLIED
Flonase Sensimist Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Spray)
Fluticasone furoate 27.5 mcg (glucocorticoid)*
*read the Question & Answer Book
Purpose
Allergy symptom reliever
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)
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.
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• 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• 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• do not use
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
CHILDREN 2 TO 11 YEARS OF AGE
CHILDREN UNDER 2 YEARS OF AGE
Other Information
• 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.
Inactive Ingredients
benzalkonium chloride solution, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, purified water
Questions Or Comments?
call toll-free 1-844-FLONASE (1-844-356-6273)
How Supplied
Product: 50090-6075
NDC: 50090-6075-0 120 SPRAY, METERED in a BOTTLE / 1 in a PACKAGE
* Please review the disclaimer below.