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, 0280-6092-24, 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 June 29, 2021

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

  • 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
  • WARNINGS

    Allergy Alert

    Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing
    • it feels like the pill is stuck in your throat
    • redness or swelling is present in the painful area
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

  • 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

  • Package label display

    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

    Aleve Back and Muscle 24 count carton

  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020401/26/2018
    Labeler - Bayer HealthCare LLC. (112117283)