FDA Label for Childrens Flonase 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?
- PRINCIPAL DISPLAY PANEL
Childrens Flonase Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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 propionate (glucocorticoid) 50 mcg
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
Warnings
Only for use in the nose. Do not spray into your eyes or mouth.
Do Not Use
• in children under 4 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:• prime the bottle• use the spray• clean the spray nozzle
• shake gently before each use• 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 4 TO 11 YEARS OF AGE
CHILDREN UNDER 4 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 4° and 30°C (39° and 86°F)• keep this label and enclosed materials. They contain important additional information.
Inactive Ingredients
benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose
Questions Or Comments?
call toll-free 1-844-FLONASE (1-844-356-6273)
Principal Display Panel
NDC 0135-0582-04
CHILDREN’S
FLONASE
ALLERGY RELIEF
FULL PRESCRIPTION STRENGTH • NON-DROWSY
Fluticasone Propionate Nasal Spray 50 mcg Per Spray
Allergy Symptom Reliever
(Glucocorticoid)*
24 Hour Relief of:
• Itchy, Watery Eyes• Nasal Congestion• Runny Nose• Itchy Nose• Sneezing
*Fluticasone propionate is a steroid medicine known as a glucocorticoid.
24 HOUR RELIEF
AGES 4 YEARS & OLDER
72 METERED SPRAYS
0.38 fl oz (11.1 mL)
IMPORTANT – Peel here for complete Drug Facts label. Children 4-11: 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. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck.
Do not use if any of these features are torn or damaged.
©2019 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
* Please review the disclaimer below.