Mucinex Nasal Congestion and Allergy Relief

FLUTICASONE PROPIONATE NASAL HUMAN OTC DRUG

Mucinex Nasal Congestion and Allergy Relief is an FDA drug label for the active ingredient FLUTICASONE PROPIONATE manufactured by Reckitt Benckiser 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 20260520.

Generic name
FLUTICASONE PROPIONATE
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
72854-227
Application
ANDA217088
Label effective
20260520

About this product

Mucinex Nasal Congestion and Allergy Relief is an FDA-registered drug product whose active ingredient is FLUTICASONE PROPIONATE. It is labelled by Reckitt Benckiser LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 72854-227, application ANDA217088, label effective 20260520. 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

Fluticasone propionate (glucocorticoid)' 50 mcg

Indications & Usage

Uses 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 IMPORTANT: Read Drug Facts on package and enclosed materials for important information. Children 4-11: 1 spray per nostril per day. Talk to a doctor if your child needs to use for longer than two months a year. Keep out of reach of children. Only for use in the nose, do not spray into eyes. Store between 4°-30°C l39°-86°F). Shake gently before each 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 info 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 constent 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 sterting this product ■ you have severe or frequent nosebleeds

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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

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1517-2016 Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 Reckitt Benckiser LLC Class III Terminated 20160928
D-1363-2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Reckitt Benckiser LLC Class I Terminated 20150902
D-1365-2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 Reckitt Benckiser LLC Class I Terminated 20150902
D-1367-2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 Reckitt Benckiser LLC Class I Terminated 20150902
D-1368-2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 Reckitt Benckiser LLC Class I Terminated 20150902

Frequently asked questions

What is Mucinex Nasal Congestion and Allergy Relief used for?
Uses 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 Mucinex Nasal Congestion and Allergy Relief?
Reckitt Benckiser LLC is the labeler of record for Mucinex Nasal Congestion and Allergy Relief. 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 Mucinex Nasal Congestion and Allergy Relief 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 Mucinex Nasal Congestion and Allergy Relief 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 Mucinex Nasal Congestion and Allergy Relief been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.