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Naproxen Sodium (Kinray)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (61715-060-50) > 50 TABLET in 1 BOTTLE, PLASTIC Label Information
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (61715-060-51) > 100 TABLET in 1 BOTTLE, PLASTIC Label Information

Complete Naproxen Sodium Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:61715-060
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color blue Score no score
    Shape OVAL (Capsule-Shaped) Size 12mm
    Flavor Imprint Code 17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-060-50 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC
    2 NDC:61715-060-51 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079096 11/25/2009
    Labeler - Kinray (012574513)
    Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Aphena Pharma Solutions - Kentucky, LLC 557054835 repack(61715-060)
    Establishment
    Name Address ID/FEI Business Operations
    Amneal Pharmaceuticals 831227801 manufacture(61715-060)