NAPROXEN SODIUM tablet, coated

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Dr.Reddy's Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Purposes

    Pain reliever/fever reducer

  • Uses

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

    Bachupally - 500 090 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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 55111-272
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code R;272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 55111-272-241 in 1 CARTON07/29/1998
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC: 55111-272-501 in 1 CARTON07/29/1998
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC: 55111-272-011 in 1 CARTON07/29/1998
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC: 55111-272-021 in 1 CARTON07/29/1998
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC: 55111-272-051 in 1 CARTON07/29/1998
    5500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516807/29/1998
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55111-273
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code R;273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 55111-273-241 in 1 CARTON07/29/1998
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC: 55111-273-501 in 1 CARTON07/29/1998
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC: 55111-273-011 in 1 CARTON07/29/1998
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC: 55111-273-021 in 1 CARTON07/29/1998
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC: 55111-273-401 in 1 CARTON07/29/1998
    5400 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC: 55111-273-051 in 1 CARTON07/29/1998
    6500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516807/29/1998
    Labeler - Dr.Reddy's Laboratories Limited (650562841)
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