Label: NAPROXEN SODIUM tablet, film coated

  • NDC Code(s): 50844-417-11, 50844-417-14, 50844-417-16, 50844-417-19, view more
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 14, 2025

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  • Active ingredient (in each tablet)
    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purpose
    Pain reliever/fever reducer
  • Uses
    temporarily relieves minor aches and pains due to: headache - muscular aches - minor pain of arthritis - toothache - the common cold - menstrual cramps - backache - temporarily reduces fever
  • Warnings
    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives - shock - rash - blisters - skin reddening - facial ...
  • Directions
    do not take more than directed - the smallest effective dose should be used - drink a full glass of water with each dose - adults and children 12 years and older - take 1 tablet every 8 to 12 hours ...
  • Other information
    each tablet contains: sodium 20 mg - use by expiration date on package - store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients
    croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
  • Questions or comments?
    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
  • Active ingredient (in each caplet)
    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purpose
    Pain reliever/fever reducer
  • Uses
    temporarily relieves minor aches and pains due to: headache - muscular aches - the common cold - toothache - backache - menstrual cramps - minor pain of arthritis - temporarily reduces fever
  • Warnings
    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening - shock - blisters - rash - facial ...
  • Directions
    do not take more than directed - the smallest effective dose should be used - drink a full glass of water with each dose - adults and children 12 years and older - take 1 caplet every 8 to 12 hours ...
  • Other information
    each caplet contains: sodium 20 mg - TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN - store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above ...
  • Inactive ingredients
    croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
  • Questions or comments?
    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
  • Principal display panel
    QUALITY - +PLUS - NDC 50844-417-16 - †Compare to - active ingredient - in Aleve® Tablets - NAPROXEN - SODIUM - TABLETS, 220 mg - PAIN RELIEVER/ FEVER REDUCER (NSAID) STRENGTH TO LAST - 12 HOURS - 1000 - Coated ...
  • Principal display panel
    QUALITY - +PLUS - NDC 50844-604-09 - †Compare to the active ingredient - in Menstridol ® NAPROXEN SODIUM - TABLETS, 220 mg - PAIN RELIEVER/FEVER REDUCER (NSAID) UP TO 12 HOURS OF MENSTRUAL PAIN ...
  • INGREDIENTS AND APPEARANCE
    Product Information