Active Ingredient
Naproxen Sodium 220mg
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc for the product Aleve Headache Pain (NDC 0280-0041). 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, purposes:, uses:, warnings:, do not use:, ask a doctor:, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen Sodium 220mg
Pain reliever/fever reducer
Allergy Alert: 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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)
Dist. by :
Bayer Healthcare LLC
Whippany, NJ 07981
ALL DAY STRONG®
ALEVE
HEADACHE PAIN
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
Bayer
For temporary relief of headache pain
ACTUAL SIZE
STRENGTH TO LAST 12 HOURS
TABLETS
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