Label: ALEVE- naproxen sodium tablet

  • NDC Code(s): 0280-6010-01, 0280-6010-02, 0280-6010-03, 0280-6010-04, view more
    0280-6010-05, 0280-6010-06, 0280-6010-07, 0280-6010-09, 0280-6010-10, 0280-6010-24, 0280-6010-50
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1

    1
    nonsteroidal anti-inflammatory drug
  • Purposes

    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
  • 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 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 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).
  • Inactive ingredients

    FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

  • Questions or comments?

    1-800-395-0689 (Mon-Fri 9AM – 5PM EST)

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Bayer HealthCare LLC
    Whippany, NJ 07981

  • WARNINGS

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

    Aleve Tablets - 24 Count CartonALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    ACTUAL SIZE
    24 TABLETS

  • INGREDIENTS AND APPEARANCE
    ALEVE 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6010
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-6010-241 in 1 CARTON07/26/2002
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0280-6010-501 in 1 CARTON07/26/2002
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0280-6010-011 in 1 CARTON07/26/2002
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-6010-021 in 1 CARTON07/26/2002
    4130 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0280-6010-031 in 1 CARTON07/26/2002
    5150 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0280-6010-041 in 1 CARTON07/26/2002
    636 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0280-6010-06225 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
    8NDC:0280-6010-051 in 1 CARTON07/26/2002
    865 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0280-6010-07270 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
    10NDC:0280-6010-0990 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
    11NDC:0280-6010-101 in 1 TRAY07/26/2002
    1110 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020407/26/2002
    Labeler - Bayer HealthCare LLC. (112117283)
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