Fluticasone Propionate FLUTICASONE PROPIONATE TWIN MED LLC FDA Approved Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose itchy watery eyes
FunFoxMeds box
Route
NASAL
Applications
ANDA208150
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each spray) Fluticasone propionate (glucocorticoid) 50 mcg
Inactive Ingredients
Inactive ingredients 0.02% w/w benzalkonium chloride dextrose microcrystalline cellulose and carboxymethylcellulose sodium 0.25% w/w phenylethyl alcohol polysorbate 80 purified water
Strengths
50 mcg
Treats Conditions
Uses Temporarily Relieves These Symptoms Of Hay Fever Or Other Upper Respiratory Allergies Nasal Congestion Runny Nose Sneezing Itchy Nose Itchy Watery Eyes

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0816516013737
UNII
O2GMZ0LF5W
Packaging

Principal Display Panel-Label label; Principal Display Panel-Carton carton

Package Descriptions
  • Principal Display Panel-Label label
  • Principal Display Panel-Carton carton

Overview

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose itchy watery eyes

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

Dosage & Administration

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 ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1: use 2 sprays in each nostril daily Week 2 through 6 months: use 1 or 2 sprays in each nostril once daily, as needed to treat symptoms After 6 months of daily use: ask a doctor if you can keep using CHILDREN 4 to 11 YEARS OF AGE the growth 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 2 months a year. an adult should supervise use use 1 spray in each nostril daily CHILDREN UNDER 4 YEARS OF AGE do not use

Warnings & Precautions
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 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 (1-800-222-1222) right away.
Purpose

Purpose Allergy symptom reliever

Do Not Use

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

When Using

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 & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions

Questions or comments Call toll-free 1-800-935-6737


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