Label: NAPROXEN SODIUM tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 1, 2025

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  • 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: • minor pain of arthritis - • muscular aches - • backache - • menstrual cramps - • headache - • toothache ...
  • WARNINGS
    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives - • facial swelling - • asthma (wheezing ...
  • DO NOT USE
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer - • right before or after heart surgery
  • ASK A DOCTOR BEFORE USE IF
    • the stomach bleeding warning applies to you - • you have a history of stomach problems, such as heartburn - • you have had high blood pressure, heart disease, liver cirrhosis,  kidney ...
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    • under a doctor's care for any serious condition - • taking aspirin for heart attack or stroke, because naproxen may decrease this benifits of aspirin - • taking any other drug
  • WHEN USING THIS PRODUCT
    • take with food or milk if stomach upset occurs
  • STOP USE AND ASK DOCTOR IF
    • you experience any of the following signs of stomach bleeding:          •feel faint -     •vomit blood -     •have bloody or black stools -     •have stomach pain that does not ...
  • PREGNANCY/BREASTFEEDING
    If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by ...
  • KEEP OUT OF REACH OF CHILDREN
    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
  • 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 ...
  • OTHER INFORMATION
    each caplet contains:sodium 20 mg - store at 20 - 25°C (68 - 77°F). avoid high humidity and excessive heat above 40°C (104°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
  • INACTIVE INGREDIENTS
    FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
  • QUESTIONS?
    call toll free - 1-844-912-4012
  • SPL UNCLASSIFIED SECTION
    Distributed by: BI-MART - Eugene, OR 97402
  • PRINCIPAL DISPLAY PANEL-100 Count
    NDC 37835-594-01 - Compare to the active ingredients in ALEVE - ®** FAST LONG-LASTING PAIN RELIEF - NAPROXEN SODIUM - CAPLETS 220 MG - PAIN RELIEVER/FEVER REDUCER (NSAID) WITH 8 TO 12 HOUR DOSING - 100 ...
  • PRINCIPAL DISPLAY PANEL-300 Count
    NDC 37835-594-03 - Compare to the active ingredients in ALEVE - ®** FAST LONG-LASTING PAIN RELIEF - NAPROXEN SODIUM - CAPLETS 220 MG - PAIN RELIEVER/FEVER REDUCER (NSAID) WITH 8 TO 12 HOUR DOSING - 300 ...
  • INGREDIENTS AND APPEARANCE
    Product Information