Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever is an FDA-registered drug product whose active ingredient is NAPROXEN SODIUM. It is labelled by Amneal Pharmaceuticals of New York LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 53746-191, application ANDA079096, label effective 20231231. It is one of 81 FDA drug label records sharing the active ingredient NAPROXEN SODIUM. 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.

Across FDA labelling, products containing NAPROXEN SODIUM are most often described in connection with: temporarily relieves, minor aches, pains due, backache muscular, pain arthritis, menstrual cramps, headache toothache, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATION AND USAGE Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor Other information each tablet contains: sodium 20 mg store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

WARNINGS Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAID, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

FDA lists 81 drug label records with NAPROXEN SODIUM 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.

What is Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever used for?
INDICATION AND USAGE Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Who makes Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever?
Amneal Pharmaceuticals of New York LLC is the labeler of record for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever. 81 FDA label records share the active ingredient NAPROXEN SODIUM, 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 Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 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 NAPROXEN SODIUM?
Yes. 81 FDA drug label records list NAPROXEN SODIUM 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 Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 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.