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
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 31, 2022

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  • 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)
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