Label: ALEVE GELCAPS- naproxen sodium tablet, coated

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

Drug Label Information

Updated November 30, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!