Label: NAPROXEN SODIUM tablet, film coated

  • NDC Code(s): 50844-417-11, 50844-417-14, 50844-417-16, 50844-417-19, view more
    50844-417-22, 50844-417-43, 50844-417-56, 50844-417-98, 50844-417-99, 50844-604-09, 50844-604-14, 50844-604-16, 50844-604-19, 50844-604-56, 50844-604-98, 50844-604-99
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 27, 2024

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  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • muscular aches
      • minor pain of arthritis
      • toothache
      • the common cold
      • menstrual cramps
      • backache
    • temporarily reduces fever
  • Warnings

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

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

    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

    • have had stomach ulcers or bleeding problems
    • are age 60 or older
    • take a blood thinning (anticoagulant) or steroid drug
    • take more or for a longer time than directed
    • 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

    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 are taking a diuretic
    • 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 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 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:
      • leg swelling
      • chest pain
      • slurred speech
      • trouble breathing
      • weakness in one part or side of body
    • pain gets worse or lasts more than 10 days
    • you have difficulty swallowing
    • any new symptoms appear
    • fever gets worse or lasts more than 3 days
    • it feels like the pill is stuck in your throat
    • redness or swelling is present in the painful area

    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.

    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 tablet contains: sodium 20 mg
    • use by expiration date on package
    • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Active ingredient (in each caplet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • muscular aches
      • the common cold
      • toothache
      • backache
      • menstrual cramps
      • minor pain of arthritis
    • temporarily reduces fever
  • Warnings

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

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

    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]
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    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 are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • 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 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:
      • slurred speech
      • trouble breathing
      • leg swelling
      • weakness in one part or side of body
      • chest pain
    • 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 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.

    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 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
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal display panel

    QUALITY
    +PLUS

    NDC 50844-417-16

    †Compare to
    active ingredient
    in Aleve® Tablets

    NAPROXEN
    SODIUM
    TABLETS, 220 mg

    PAIN RELIEVER/
    FEVER REDUCER (NSAID)

    STRENGTH TO LAST
    12 HOURS

    1000
    Coated Tablets

    ACTUAL
    SIZE

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR
    MISSING

    †This product is not manufactured or distributed by Bayer
    HealthCare LLC, owner of the registered trademark Aleve® Tablets.
    50844         REV1221C41716

    Distributed by: LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788
    USA

    Quality Plus 44-417

    Quality Plus 44-417

  • Principal display panel

    QUALITY
    +PLUS

    NDC 50844-604-09

    †Compare to the active ingredient
    in Menstridol ®

    NAPROXEN SODIUM
    TABLETS, 220 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    UP TO 12 HOURS OF MENSTRUAL PAIN RELIEF

    Temporarily relieves minor cramps, backache, headache

    20 Coated Caplets**
    **CAPSULE-SHAPED TABLETS

    ACTUAL
    SIZE

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    †This product is not manufactured or distributed by Bayer HealthCare LLC, owner
    of the registered trademark Menstridol®.         50844           REV1221C60409

    Distributed by: LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    Quality Plus 44-604

    Quality Plus 44-604

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-417
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;417
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-417-2248 in 1 CARTON02/01/2017
    1NDC:50844-417-431 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:50844-417-1160 in 1 CARTON02/01/2017
    2NDC:50844-417-431 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:50844-417-998 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    4NDC:50844-417-988 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    5NDC:50844-417-191 in 1 CARTON02/01/2017
    58 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:50844-417-5625 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    7NDC:50844-417-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    8NDC:50844-417-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20487202/01/2017
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-604
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 44;604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-604-998 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    2NDC:50844-604-988 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    3NDC:50844-604-191 in 1 CARTON02/01/2017
    38 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:50844-604-5625 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    5NDC:50844-604-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    6NDC:50844-604-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    7NDC:50844-604-094 in 1 CARTON02/01/2017
    75 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20487202/01/2017
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-417, 50844-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(50844-417, 50844-604) , pack(50844-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(50844-417, 50844-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-417, 50844-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(50844-417, 50844-604)
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