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Naproxen Sodium (Dr.Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE in 1 CARTON (55111-272-01) > 100 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (55111-272-05) > 500 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (55111-272-24) > 24 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (55111-272-02) > 200 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (55111-272-50) > 50 TABLET, COATED in 1 BOTTLE Label Information

Complete Naproxen Sodium Information

  • SPL UNCLASSIFIED SECTION

    PAIN RELIEVER / FEVER REDUCER (NSAID)

    Drug Facts


  • Active ingredient (in each tablet/caplet)

    Naproxen sodium USP, 220 mg
    (naproxen USP, 200 mg) (NSAID)1


    1
    • nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer


  • Uses

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

  • Warnings

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

    • hives
    • asthma (wheezing)
    • skin reddening
    • facial swelling
    • shock
    • 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 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 NSAID's (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

    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 ofstomach 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.


  • 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/caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets/caplets within the first hour
    • do not exceed 2 tablets/caplets in any 8- to 12-hour period
    • do not exceed 3 tablets/caplets in a 24-hour period
    Children under 12 years
    • ask a doctor

  • Other information

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

  • Inactive ingredients

    FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide


  • Questions?

    call 1-888-375-3784


  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachepalli - 502 325 INDIA


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    Caplets

    Container

    capletcontainer


  • PRINCIPAL DISPLAY PANEL

    Container Carton

    capletcarton


  • Tablets

    Container

    tabletcontainer


  • PRINCIPAL DISPLAY PANEL

    Container Carton

    tabletcarton


  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-272
    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
    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)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code R;272
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-272-24 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:55111-272-50 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:55111-272-01 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:55111-272-02 1 in 1 CARTON
    4 200 in 1 BOTTLE
    5 NDC:55111-272-05 1 in 1 CARTON
    5 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075168 07/29/1998
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-273
    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
    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)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 12mm
    Flavor Imprint Code R;273
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-273-24 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:55111-273-50 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:55111-273-01 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:55111-273-02 1 in 1 CARTON
    4 200 in 1 BOTTLE
    5 NDC:55111-273-40 1 in 1 CARTON
    5 400 in 1 BOTTLE
    6 NDC:55111-273-05 1 in 1 CARTON
    6 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075168 07/29/1998
    Labeler - Dr.Reddy's Laboratories Limited (862179079)