Nasonex

MOMETASONE FUROATE NASAL HUMAN OTC DRUG

Nasonex is an FDA drug label for the active ingredient MOMETASONE FUROATE manufactured by L. Perrigo Company 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 20260819.

Generic name
MOMETASONE FUROATE
Manufacturer
L. Perrigo Company
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
0113-1720
Application
NDA215712
Label effective
20260819

About this product

Nasonex is an FDA-registered drug product whose active ingredient is MOMETASONE FUROATE. It is labelled by L. Perrigo Company taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 0113-1720, application NDA215712, label effective 20260819. It is one of 22 FDA drug label records sharing the active ingredient MOMETASONE FUROATE. 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 MOMETASONE FUROATE are most often described in connection with: temporarily relieves, symptoms hay, upper respiratory, allergies nasal, congestion runny, nose sneezing. 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) Mometasone furoate monohydrate (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

Dosage & Administration

Directions Read insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently Children 2 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 • 1 spray in each nostril once daily while sniffing gently Children under 2 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 2 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 an eye infection • 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 may occur for a few seconds right after use • you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day 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 chickenpox, 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 breastfeeding, 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 MOMETASONE FUROATE compare

FDA lists 22 drug label records with MOMETASONE FUROATE 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
— — Bryant Ranch Prepack 5
— — Cosette Pharmaceuticals, Inc. 2
— — Glenmark Pharmaceuticals Inc., USA 2
— — Organon LLC 2
— — Padagis Israel Pharmaceuticals Ltd 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-0912-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. L. Perrigo Company Class II Terminated 20230719
D-0910-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. L. Perrigo Company Class II Terminated 20230719
D-0909-2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. L. Perrigo Company Class II Terminated 20230719
D-0906-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. L. Perrigo Company Class II Terminated 20230719
D-0903-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39 L. Perrigo Company Class II Terminated 20230719

Frequently asked questions

What is Nasonex used for?
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose

Who makes Nasonex?
L. Perrigo Company is the labeler of record for Nasonex. 22 FDA label records share the active ingredient MOMETASONE FUROATE, 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 Nasonex 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 Nasonex 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 MOMETASONE FUROATE?
Yes. 22 FDA drug label records list MOMETASONE FUROATE 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 Nasonex 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.