Label: ALEVE GELCAPS- naproxen sodium tablet, coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 21, 2022

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

    D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, 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

  • PRINCIPAL DISPLAY PANEL

    Aleve Gelcaps -  40 Count CartonSOFT GRIP® ARTHRITIS CAP

    ALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    THIS PACKAGE IS

    CHILD-RESISTANT

    STRENGTH

    TO LAST

    12 HOURS

    40 GELCAPS

    GELATIN COATED

    CAPSULE-SHAPED TABLETS

  • INGREDIENTS AND APPEARANCE
    ALEVE  GELCAPS
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6070
    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
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-6070-401 in 1 CARTON08/01/2002
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020408/01/2002
    Labeler - Bayer HealthCare LLC. (112117283)