Label: ALEVE BACK AND MUSCLE PAIN- naproxen sodium tablet

  • NDC Code(s): 0280-6092-02, 0280-6092-04, 0280-6092-05, 0280-6092-06, view more
    0280-6092-07, 0280-6092-08, 0280-6092-09, 0280-6092-10, 0280-6092-12, 0280-6092-24, 0280-6092-25, 0280-6092-50
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg)

    (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • backache
      • muscular aches
      • minor pain of arthritis
      • menstrual cramps
      • headache
      • toothache
      • the common cold
    • temporarily reduces fever
  • DOSAGE & ADMINISTRATION

    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 tablets 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 SAFETY INFORMATION

    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 INGREDIENT

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

  • QUESTIONS

    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.

  • Package label display

    Aleve Back and Muscle Pain - 24 Count Carton All Day Strong®

    Aleve®

    Back & Muscle Pain

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    Bayer

    For temporary relief of minor back and muschle aches and pains

    ACTUAL SIZE

    Strength to Last 12 Hours 24Tablets

  • INGREDIENTS AND APPEARANCE
    ALEVE BACK AND MUSCLE PAIN 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6092
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-6092-241 in 1 CARTON01/26/2018
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0280-6092-501 in 1 CARTON01/26/2018
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0280-6092-101 in 1 CARTON01/26/201809/30/2023
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-6092-251 in 1 CARTON08/06/2019
    4250 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0280-6092-021 in 1 CARTON01/26/2018
    5130 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0280-6092-041 in 1 CARTON01/26/2018
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0280-6092-051 in 1 CARTON01/26/2018
    7225 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0280-6092-061 in 1 CARTON01/26/201803/31/2022
    836 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0280-6092-071 in 1 CARTON01/26/201811/30/2021
    965 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0280-6092-081 in 1 CARTON07/01/2021
    10250 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:0280-6092-091 in 1 CARTON07/01/2021
    1190 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0280-6092-1210 in 1 VIAL; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020401/26/2018
    Labeler - Bayer HealthCare LLC. (112117283)
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