Active Ingredient (In Each Tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Naproxen Back And Muscle Pain (NDC 50844-714). 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 tablet), purpose, 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.
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 (1-800-222-1222) right away.
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
QUALITY
+PLUS
NDC 50844-714-16
†Compare to
active ingredient in
Aleve® Back & Muscle
Pain Tablets
NAPROXEN
BACK AND MUSCLE PAIN
NAPROXEN SODIUM
TABLETS, 220 mg
PAIN RELIEVER/FEVER
REDUCER (NSAID)
For temporary relief of minor back
and muscle aches and pains
Strength to last 12 hours
1000
Coated Tablets
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Aleve®
Back & Muscle Pain Tablets. 50844 ORG041841716
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
* Please review the disclaimer below.