Label: NAPROXEN SODIUM tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 30, 2013

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

  • Active ingredient (in each caplet)

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

  • Purposes

    Pain reliever/ fever reducer

  • Uses

    • temporarily relieves minor aches and pain 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 everyday 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
    • 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 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. (1-800-222-1222)

  • 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 20o- 25oC (68o- 77oF). Avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive Ingredients:

    croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, and titanium dioxide

  • Questions or comments? 1-877-586-7979

  • PRINCIPAL DISPLAY PANEL - 220 mg TABLET CARTON

    Preferred Plus Pharmacy

    NDC 61715-060-50

    SEE NEW WARNINGS INFORMATION

    *Compare to the Active Ingredient in Aleve®

    Naproxen Sodium Tablets, USP 220 mg

     Pain Reliever/Fever Reducer (NSAID)

    50 COATED CAPLETS†

    †CAPSULE-SHAPED TABLETS

    Distributed By:

    Kinray, Inc., Whitestone, NY 11357

    (c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

    image description

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-060
    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 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (Capsule-Shaped) Size12mm
    FlavorImprint Code 17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-060-501 in 1 CARTON
    150 in 1 BOTTLE, PLASTIC
    2NDC:61715-060-511 in 1 CARTON
    2100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909611/25/2009
    Labeler - Kinray (012574513)
    Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Kentucky, LLC557054835repack(61715-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals831227801manufacture(61715-060)