Label: NAPROXEN SODIUM tablet, film coated

  • NDC Code(s): 68016-676-00, 68016-676-24, 68016-676-50, 68016-676-90
  • Packager: Chain Drug Consortium
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2023

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  • 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]
    • 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 have problems or serious side effects from taking pain relievers or fever reducers
    • you are taking a diuretic

    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
    • 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
    • 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

    †COMPARE TO THE ACTIVE INGREDIENT
    IN ALEVE® CAPLETS

    Premier Value®

    Naproxen Sodium Caplets
    Naproxen Sodium Tablets, 220 mg
    Pain Reliever/Fever Reducer (NSAID)

    STRENGTH TO LAST 12 HOURS

    100 Film Coated Caplets**
    **CAPSULE-SHAPED TABLETS

    actual
    size

    PV
    INDEPENDENTLY TESTED
    SATISFACTION GUARANTEED

    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® Caplets. 50844   REV1221B60412

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

    PV
    INDEPENDENTLY TESTED
    SATISFACTION GUARANTEED

    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    Premier Value 44-604

    Premier Value 44-604

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-676
    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:68016-676-241 in 1 CARTON03/19/2020
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68016-676-501 in 1 CARTON03/19/2020
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:68016-676-001 in 1 CARTON03/19/2020
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:68016-676-901 in 1 CARTON03/19/2020
    490 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20487203/19/2020
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(68016-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(68016-676) , pack(68016-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(68016-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(68016-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(68016-676)
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