Active Ingredient (In Each Capsule)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Aafes/your Military Exchanges for the product Naproxen Sodium (NDC 55301-748). 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 capsule), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, 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, 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
take with food or milk if stomach upset occurs
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
FD&C blue #1, gelatin, glycerin, lactic acid,lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone K30, propylene glycol, purified water, shellac glaze, sorbitan sorbitol solution,titanium dioxide, white ink
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†Compare to the active ingredient in Aleve®
Naproxen Sodium
Capsules, 220 mg
Pain Reliever/Fever Reducer (NSAID)
STRENGTH TO LAST 12 HOURS
CAPSULES
†This product is not manufactured or distributed by Bayer HealthCare, LLC, Distributor of Aleve®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Manufactured For Your Military Exchange
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