Label: BAYER ALEVE- naproxen sodium tablet

  • NDC Code(s): 47682-488-50
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 15, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

    *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 stomach ulcers or bleeding problems
    • take a blood thinner (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:

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

    Ask a doctor before use if

    • 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 for more than 10 days
    • fever gets worse or lasts for 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 accidental 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 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 exceedc3 caplets 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 40ºC (104ºF)
  • 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)

  • PRINCIPAL DISPLAY PANEL

    All Day Strong ®

    Aleve ®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    Bayer

    Pull To Open

    Strength To Last 12 Hours

    50 Caplets

    Capsule-Shaped Tablets

    Bayer Aleve

  • INGREDIENTS AND APPEARANCE
    BAYER ALEVE 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-488
    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, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-488-5050 in 1 BOX01/24/2014
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020401/24/2014
    Labeler - Unifirst First Aid Corporation (832947092)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer Healthcare LLC072827066manufacture(47682-488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794repack(47682-488)