ALEVE- naproxen sodium capsule, liquid filled

Aleve by

Drug Labeling and Warnings

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

Drug Details [pdf]

  • 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

    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, or kidney disease
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have asthma

    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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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

    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
    • if taken with food, this product may take longer to work
    adults and children 12 years and older:
    • take 1 capsule every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 capsules within the first hour
    • do not exceed 2 capsules in any 8- to 12-hour period
    • do not exceed 3 capsules in a 24-hour period
    children under 12 years:
    • ask a doctor
  • Other information

    • each capsule contains: sodium 20 mg
    • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)
    • read all directions and warnings before use. Keep carton.
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

  • Questions or comments?

    1-800-395-0689
    (Mon – Fri 9AM – 5PM EST) or www.aleve.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Bayer HealthCare LLC
    Consumer Care
    P.O. Box 1910
    Morristown, NJ 07962-1910 USA

  • PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton

    See new warnings information

    ALEVE®

    LIQUID GELS

    naproxen sodium capsules, 220 mg (NSAID)

    pain reliever/fever reducer

    Bayer HealthCare

    ALL DAY STRONG®

    12 HOURS STRONG

    40

    LIQUID GELS


    (LIQUID FILLED CAPSULES)

    Carton

  • INGREDIENTS AND APPEARANCE
    ALEVE 
    naproxen sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0280-6080
    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. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (Blue with white text) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code ALEVE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0280-6080-201 in 1 CARTON02/20/2007
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC: 0280-6080-401 in 1 CARTON02/20/2007
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC: 0280-6080-801 in 1 CARTON02/20/2007
    380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC: 0280-6080-16160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02192002/20/2007
    Labeler - Bayer HealthCare LLC. (112117283)

  • 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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