Label: ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP- naproxen sodium tablet

  • NDC Code(s): 0280-6050-01, 0280-6050-02, 0280-6050-03, 0280-6050-04, view more
    0280-6050-27, 0280-6050-50
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 11, 2020

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

  • 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

  • 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 any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    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.

  • 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 caplet contains: sodium 20 mg
    • store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    FD&C blue #2 lake, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidones, 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

  • PRINCIPAL DISPLAY PANEL - 270 Caplet Bottle Carton

    SOFT 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

    270 CAPLETS

    CAPSULE-SHAPED TABLETS

    Carton label

  • INGREDIENTS AND APPEARANCE
    ALEVE  CAPLETS - EASY OPEN ARTHRITIS CAP
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6050
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    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:0280-6050-501 in 1 CARTON11/11/2013
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0280-6050-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2013
    3NDC:0280-6050-271 in 1 CARTON11/11/2013
    3270 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-6050-0224 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    5NDC:0280-6050-031 in 1 CARTON11/11/2013
    5130 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0280-6050-041 in 1 CARTON11/11/2013
    6150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020411/11/2013
    Labeler - Bayer HealthCare LLC. (112117283)