Label: NAPROXEN SODIUM tablet

  • NDC Code(s): 62207-750-41, 62207-750-42, 62207-750-43, 62207-750-44, view more
    62207-750-45, 62207-750-47, 62207-750-49, 62207-750-51, 62207-750-52, 62207-750-53, 62207-753-41, 62207-753-42, 62207-753-43, 62207-753-44, 62207-753-45, 62207-753-47, 62207-753-49, 62207-753-51, 62207-753-52, 62207-753-53
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2023

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  • ACTIVE INGREDIENT

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • INDICATIONS AND USAGE

    • 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
  • 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 DOCTOR

    • 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 DOCTOR/PHARMACIST

    • under a doctor’s care for any serious condition
    • taking any other drug
  • WHEN USING

    • 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

    • 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
    • you develop heartburn
    • redness or swelling is present in the painful area
    • any new symptoms appear
  • PREGNANCY 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.

  • DOSAGE AND ADMINISTRATION

    • 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 oldertake 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 yearsask a doctor

    Information for Patients

    • each tablet contains: sodium 20 mg
    • store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
    • do not use if foil seal on bottle opening is missing or broken.
  • INACTIVE INGREDIENT

    FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

  • QUESTIONS

    1-877-770-3183 Mon – Fri 9:00 AM to 4:00 PM EST

    M.L. 37/RR/AP/2003/F/R

    MADE IN INDIA

    Manufactured By:

    Granules India Limited

    2nd Floor 3rd Block, My Home hub

    Madhapur, Hyderabad – 500 081, India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    C:\Users\Administrator\Desktop\spl sci\spl2\nap-sod capsule-shaped-tablets.jpgC:\Users\Administrator\Desktop\spl sci\spl2\nap-sod tablets.jpg

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-750
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-750-4124 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    2NDC:62207-750-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    3NDC:62207-750-4343 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    4NDC:62207-750-44150 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    5NDC:62207-750-45200 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    6NDC:62207-750-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    7NDC:62207-750-491000 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    8NDC:62207-750-5110 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    9NDC:62207-750-52300 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    10NDC:62207-750-53400 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135309/30/2011
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-753
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (Capsule-Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-753-4124 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    2NDC:62207-753-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    3NDC:62207-753-4343 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    4NDC:62207-753-44150 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    5NDC:62207-753-45200 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    6NDC:62207-753-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    7NDC:62207-753-491000 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    8NDC:62207-753-5110 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    9NDC:62207-753-52300 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    10NDC:62207-753-53400 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135309/30/2011
    Labeler - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236analysis(62207-750, 62207-753) , manufacture(62207-750, 62207-753) , pack(62207-750, 62207-753) , label(62207-750, 62207-753)
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