Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 220 mg/1

Naproxen Sodium · TABLET · Amneal Pharmaceuticals of New York LLC

No Recall History

Plain English

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever is a tablet containing naproxen sodium at 220 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name: Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever
Generic Name: Naproxen Sodium
NDC Code (Product): 53746-192
Manufacturer: Amneal Pharmaceuticals of New York LLC
Strength: 220 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA079096
Marketing Start: 11/25/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,873 reports

fatigue2,619 reports

off label use2,508 reports

pain2,446 reports

rash2,238 reports

arthralgia2,196 reports

diarrhoea2,195 reports

vomiting2,126 reports

condition aggravated2,100 reports

joint swelling2,057 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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.

Frequently Asked Questions

What is Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever used for?

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever contains Naproxen Sodium. It is a tablet taken oral. Consult your doctor for specific uses.

Is Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever a controlled substance?

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever is not classified as a controlled substance by the DEA.

What is the generic name for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever?

The generic name for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 220 mg/1?

The NDC (National Drug Code) for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 220 mg/1 is 53746-192, listed by Amneal Pharmaceuticals of New York LLC.

Product NDC

53746-192

Package NDC

53746-192-05

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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