topcare fluticasone propionate nasal

topcare fluticasone propionate nasal is an FDA drug label for the active ingredient FLUTICASONE PROPIONATE manufactured by Topco Associates LLC administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20221101.

Generic: FLUTICASONE PROPIONATE

Manufacturer: Topco Associates LLC

Product Type: HUMAN OTC DRUG

Route: NASAL

Dosage Form:

NDC: 36800-222

Application: ANDA207957

Effective: 20221101

Active Ingredients: Active ingredient (in each spray) Fluticasone propionate (glucocorticoid) 50 mcg

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

Contraindications

Not available.

Warnings

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 right away (1-800-222-1222).

Adverse Reactions

Not available.

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