ALEVE- naproxen sodium tablet tablet

Aleve by

Drug Labeling and Warnings

Aleve by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Purpose

    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

    • 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

    • 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

    Keep out of reach of children.

    n case of overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen
    sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • 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)

  • PRINCIPAL DISPLAY PANEL - 220 mg Caplet Pouch Box

    ALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    30 POUCHES

    1 PILL PER POUCH

    Capsule-Shaped Tablet

    Aleve 30ct

  • Principal Display Panel- 220 mg 2 Caplet Pouch Package

    ALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    2 Caplets

    Capsule-Shaped Tablets

    Aleve 2 caplets

  • PRINCIPAL DISPLAY PANEL- 220 mg 3 Caplet Pouch Package

    ALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets, 220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    3 Caplets

    Capsule-Shaped Tablet

    Aleve 3 caplets

  • Aleve CVP 2 Count Carton

    ALL DAY STRONG ®

    ALEVE ®

    naproxen sodium tablets, 220 mg (NSAID)
    Pain reliever/fever reducer

    [Bayer Cross]

    [tablet image]

    ACTUAL SIZE

    STRENGTH TO LAST

    12 HOURS

    2 Caplets
    Capsule-Shaped Tablets

    CVP

    HEALTH

    Aleve CVP 2 ct

  • INGREDIENTS AND APPEARANCE
    ALEVE 
    naproxen sodium tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29485-6751
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Aleve
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 29485-6751-63 in 1 BLISTER PACK02/06/201709/30/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020402/06/200209/30/2025
    ALEVE 
    naproxen sodium tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29485-1013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Aleve
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 29485-1013-22 in 1 BLISTER PACK04/30/200209/30/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020404/30/200209/30/2025
    ALEVE 
    naproxen sodium tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29485-7534
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Aleve
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 29485-7534-330 in 1 BOX11/01/201612/31/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020411/01/201612/31/2025
    ALEVE 
    naproxen sodium tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29485-6502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Aleve
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 29485-6502-44 in 1 CARTON08/25/201709/30/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC: 29485-6502-22 in 1 CARTON09/30/202212/31/2025
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02020408/25/201712/31/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)

  • Trademark Results [Aleve]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALEVE
    ALEVE
    87130338 5279528 Live/Registered
    Bayer HealthCare LLC
    2016-08-08
    ALEVE
    ALEVE
    86018399 4459303 Live/Registered
    Bayer HealthCare LLC
    2013-07-24
    ALEVE
    ALEVE
    77105868 3287780 Live/Registered
    Bayer HealthCare LLC
    2007-02-13
    ALEVE
    ALEVE
    75659920 2321672 Dead/Cancelled
    BAYER CONSUMER CARE LLC
    1999-03-12
    ALEVE
    ALEVE
    75659913 2321671 Dead/Cancelled
    BAYER CONSUMER CARE LLC
    1999-03-12
    ALEVE
    ALEVE
    75626019 2323878 Dead/Cancelled
    BAYER CONSUMER CARE LLC
    1999-01-25
    ALEVE
    ALEVE
    75626018 2346840 Dead/Cancelled
    BAYER CONSUMER CARE LLC
    1999-01-25
    ALEVE
    ALEVE
    75204472 2177899 Dead/Cancelled
    BAYER HEALTHCARE LLC
    1996-11-26
    ALEVE
    ALEVE
    73746999 not registered Dead/Abandoned
    RICHARDSON-VICKS INC.
    1988-08-18
    ALEVE
    ALEVE
    73726530 1536042 Live/Registered
    SYNTEX PUERTO RICO, INC.
    1988-05-05

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