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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Aleve (NDC 0280-6070). 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 other, active ingredient (in each tablet), purposes, uses, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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 |
|
| Children under 12 years |
|
D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide
1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com
SOFT GRIP
®
ARTHRITIS CAP
ALL DAY STRONG®
ALEVE
®
naproxen sodium tablets, 220 mg
(NSAID)
Pain reliever/fever reducer
THIS PACKAGE IS
CHILD-RESISTANT
STRENGTH
TO LAST
12 HOURS
40 GELCAPS
GELATIN COATED
CAPSULE-SHAPED TABLETS
* Please review the disclaimer below.