Label: ALEVE CAPLETS- naproxen sodium tablet

  • NDC Code(s): 0280-6000-01, 0280-6000-02, 0280-6000-03, 0280-6000-04, view more
    0280-6000-05, 0280-6000-06, 0280-6000-07, 0280-6000-08, 0280-6000-09, 0280-6000-10, 0280-6000-12, 0280-6000-15, 0280-6000-16, 0280-6000-24, 0280-6000-27, 0280-6000-32, 0280-6000-50, 0280-6000-70, 0280-6000-75
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 31, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    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 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8- to 12-hour period
    • do not exceed 3 caplets in a 24-hour period
    Children under 12 years
    • ask a doctor
  • 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).
  • 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

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    ALL DAY STRONG ®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    ACTUAL SIZE

    24 CAPLETS


    CAPSULE-SHAPED TABLETS

    Aleve Caplets - 24 Count Carton

  • INGREDIENTS AND APPEARANCE
    ALEVE  CAPLETS
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6000
    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
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (capsule shaped tablets) Size12mm
    FlavorImprint Code Aleve
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-6000-061 in 1 CARTON02/26/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0280-6000-241 in 1 CARTON02/26/2014
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0280-6000-501 in 1 CARTON02/26/2014
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-6000-101 in 1 CARTON02/26/201406/30/2022
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0280-6000-151 in 1 CARTON02/26/201407/31/2020
    5150 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0280-6000-021 in 1 CARTON03/26/2014
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0280-6000-27270 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
    8NDC:0280-6000-321 in 1 CARTON02/26/2014
    8320 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0280-6000-701 in 1 CARTON03/18/2016
    9150 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0280-6000-751 in 1 CARTON03/18/201601/30/2020
    10180 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:0280-6000-0124 in 1 BOTTLE; Type 0: Not a Combination Product02/26/2014
    12NDC:0280-6000-031 in 1 CARTON02/26/2014
    12130 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:0280-6000-041 in 1 CARTON02/26/2014
    13225 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:0280-6000-051 in 1 CARTON02/26/2014
    1436 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:0280-6000-0748 in 1 POUCH; Type 0: Not a Combination Product02/26/2014
    16NDC:0280-6000-081 in 1 CARTON02/26/2014
    1665 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:0280-6000-121 in 1 CARTON07/01/2021
    1790 in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:0280-6000-091 in 1 POUCH; Type 0: Not a Combination Product07/01/2020
    19NDC:0280-6000-161 in 1 POUCH; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020402/26/2014
    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

More Info on this Drug

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