Label: NAPROXEN SODIUM- naproxen sodium tablet, coated tablet
NAPROXEN SODIUM- naproxen sodium, coated tablets tablet

  • NDC Code(s): 25000-141-02, 25000-141-14, 25000-141-26, 25000-141-30, view more
    25000-141-43, 25000-141-98, 25000-144-02, 25000-144-14, 25000-144-20, 25000-144-30, 25000-144-43, 25000-144-98
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 9, 2023

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

View All Sections
  • Active ingredient(s)


    For Tablets:
    Active ingredient (in each tablet)
    Naproxen sodium 220 mg
    (naproxen 200 mg) (NSAID)*
    *nonsteroidal anti-inflammatory drug

     


    For Caplets:
    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:
     

     • 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 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 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 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 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 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. (1-800-222-1222)

  • Directions

    For Tablets:

    • 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

    For Caplets:

    • 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

    For Tablets:

    • each tablet contains: sodium 20 mg
    • store at 20-25ºC (68-77ºF).
    • avoid high humidity and excessive heat above 40°C (104°F).  


    For Caplets:

    • each caplet contains: sodium 20 mg
    • store at 20-25ºC (68-77ºF).
    • avoid high humidity and excessive heat above 40°C (104°F).  

  • Inactive ingredients


    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
     

     

  • Questions or comments?

    call toll free 1-877-376-4271

     

    Manufactured for:

    Time-Cap Labs, Inc.

    7 Michael Avenue, Farmingdale,

    NY 11735, USA


    Manufactured by:

    Marksans Pharma Ltd.

    Plot No. L-82, L-83,

    Verna Indl. Estate,

    Verna, Goa - 403722, India.


    Mfg. Lic. No.: GO/DRUGS/515

  • Principal Display Panel

    NDC 25000-141-43
    Naproxen Sodium Tablets, USP 220 mg
    10’s count bottle label


    nap-sod-tabs-bottle-10s


    NDC 25000-141-43
    Naproxen Sodium Tablets, USP 220 mg
    10’s count carton label

    nap-sod-tablets-ifc-10s

    NDC 25000-141-02
    Naproxen Sodium Tablets, USP 220 mg
    24’s count bottle label

    nap-sod-tabs-bottle-24s
     


    NDC 25000-141-02
    Naproxen Sodium Tablets, USP 220 mg
    24’s count carton label


    nap-sod-tablets-ifc-24s



    NDC 25000-141-14
    Naproxen Sodium Tablets, USP 220 mg
    1000’s count bottle label

    nap-sod-tabs-bottle-1000s
     

    NDC 25000-144-14
    Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
    1000’s count bottle label

    nap-sod-caplet-bott-1000

    NDC 25000-144-43
    Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
    10’s count bottle label

     
    nap-sod-caps-bottle-10s

    NDC 25000-144-43
    Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
    10’s count carton label


    nap-sod-caplets-ifc-10s


    NDC 25000-144-02
    Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
    24’s count bottle label

    nap-sod-caps-bottle-24s
     


    NDC 25000-144-02
    Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
    24’s count carton label

    nap-sod-caplets-ifc-24s

     


  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-144
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-144-141000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2011
    2NDC:25000-144-204 in 1 BOX05/04/2011
    26500 in 1 BAG; Type 0: Not a Combination Product
    3NDC:25000-144-306 in 1 BOX05/04/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-144-02160 in 1 BOX05/04/2011
    41 in 1 CARTON
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-144-4310 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2011
    6NDC:25000-144-981 in 1 BOX05/04/2011
    632165 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/04/2011
    NAPROXEN SODIUM 
    naproxen sodium, coated tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-141
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-141-141000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2011
    2NDC:25000-141-262 in 1 BOX05/28/2011
    21600 in 1 BAG; Type 0: Not a Combination Product
    3NDC:25000-141-306 in 1 BOX05/28/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-141-02160 in 1 BOX05/28/2011
    41 in 1 CARTON
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-141-4310 in 1 BOTTLE; Type 0: Not a Combination Product05/28/2011
    6NDC:25000-141-981 in 1 BOX05/28/2011
    632165 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/28/2011
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-141, 25000-144)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!