Active Ingredient (In Each Caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) *
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Aleve (NDC 67751-144). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purposes, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) *
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert
Naproxen sodium may cause a severe allergic reaction, especialy in people allergic to asprin. Symptoms may include:
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 chace is higher if you:
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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma
Ask a doctor or pharmacist before use if you are
• under a doctor's care for any serious condition
• taking any other drug
When using this product
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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.
Adults and Children 12 years and older |
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Children under 12 years |
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FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com
* Please review the disclaimer below.