TopCare Childrens Allergy Relief Nasal 24 Hour

FLUTICASONE PROPIONATE NASAL HUMAN OTC DRUG

TopCare Childrens Allergy Relief Nasal 24 Hour 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 20260811.

Generic name
FLUTICASONE PROPIONATE
Manufacturer
Topco Associates LLC
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
36800-128
Application
ANDA207957
Label effective
20260811

About this product

TopCare Childrens Allergy Relief Nasal 24 Hour is an FDA-registered drug product whose active ingredient is FLUTICASONE PROPIONATE. It is labelled by Topco Associates LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 36800-128, application ANDA207957, label effective 20260811. It is one of 50 FDA drug label records sharing the active ingredient FLUTICASONE PROPIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing FLUTICASONE PROPIONATE are most often described in connection with: temporarily relieves, symptoms hay, upper respiratory, allergies nasal, congestion itchy, nose runny, watery eyes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each spray) Fluticasone propionate (glucocorticoid)* 50 mcg * read the Question & Answer Leaflet

Indications & Usage

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

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 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 4 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 4 YEARS OF AGE • do not use

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 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 (1-800-222-1222).

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How products containing FLUTICASONE PROPIONATE compare

FDA lists 50 drug label records with FLUTICASONE PROPIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — A-S Medication Solutions 4
— — Allegiant Health 3
— — American Sales Company 2
— — Bryant Ranch Prepack 2
— — Cosette Pharmaceuticals, Inc. 2

Frequently asked questions

What is TopCare Childrens Allergy Relief Nasal 24 Hour used for?
Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing

Who makes TopCare Childrens Allergy Relief Nasal 24 Hour?
Topco Associates LLC is the labeler of record for TopCare Childrens Allergy Relief Nasal 24 Hour. 50 FDA label records share the active ingredient FLUTICASONE PROPIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TopCare Childrens Allergy Relief Nasal 24 Hour come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TopCare Childrens Allergy Relief Nasal 24 Hour prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUTICASONE PROPIONATE?
Yes. 50 FDA drug label records list FLUTICASONE PROPIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TopCare Childrens Allergy Relief Nasal 24 Hour been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.