NAPROXEN SODIUM tablet, coated

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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
      • the common cold
    • temporarily reduces fever
  • 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)
    • shock
    • skin reddening
    • rash
    • blisters

    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:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma
    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke

    Stop use and ask a doctor if

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • 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 get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing
    • it feels like the pill is stuck in your throat
    • you develop heartburn
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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.

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • drink a full glass of water with each dose
    adults and children 12 years and older
    • take 1 tablet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets within the first hour
    • do not exceed 2 tablets in any 8- to 12-hour period
    • do not exceed 3 tablets in a 24-hour period
    children under 12 years
    • ask a doctor
  • Other information

    • each tablet contains: sodium 20 mg
    • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    • retain carton for complete product information
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    NDC: 63868-465-50

    QUALITY CHOICE

    †Compare to the active ingredient in ALEVE®

    Naproxen Sodium

    Non-Prescription Strength

    Naproxen Sodium Tablets, 220mg

    Pain Reliever / Fever Reducer (NSAID)

    50 Tablets

    50 count

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63868-465
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63868-465-501 in 1 CARTON09/03/2009
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC: 63868-465-011 in 1 CARTON09/03/2009
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909609/03/2009
    Labeler - Chain Drug Marketing Association (011920774)
    • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.