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Naproxen

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Generic:NAPROXEN SODIUM
Manufacturer:discount drug mart, l.n.k. international, inc.
Drug Classes:Not Available
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Naproxen

Generic:NAPROXEN SODIUM
Manufacturer:discount drug mart, l.n.k. international, inc., amerisource bergen
Drug Classes:Not Available
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Synopsis
Contents
Indication and UsageDosage & Side EffectsWarnings
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Synopsis
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Naproxen
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Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Indication and Usage

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

Dosage & Side Effects

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

Warnings

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening shock blisters rash facial swelling hives 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] take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product Heart attack and stroke warning: NSAIDs, 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. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Approval History
FDA approved 2017
Includes history for all formulations of adalimumab
September 16, 2025 (Type 1 - New Molecular Entity)
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September 16, 2025 (Type 1 - New Molecular Entity)
April 23, 2025 (Type 1 - New Molecular Entity)
January 23, 2017 (Type 1 - New Molecular Entity)
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