Label: NAPROXEN SODIUM tablet
NAPROXEN SODIUM tablet, film coated

  • NDC Code(s): 62207-327-41, 62207-327-42, 62207-327-43, 62207-327-47, view more
    62207-327-49, 62207-328-41, 62207-328-42, 62207-328-43, 62207-328-47, 62207-328-49, 62207-728-24, 62207-728-42, 62207-728-43, 62207-728-47, 62207-728-49, 62207-729-24, 62207-729-42, 62207-729-43, 62207-729-47, 62207-729-49, 62207-761-42, 62207-761-43, 62207-761-47, 62207-761-49, 62207-762-42, 62207-762-43, 62207-762-47, 62207-762-49
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2023

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

  • ACTIVE INGREDIENT(S)

    (in each tablet/caplet)

    Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USE(S)

    • 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

    Heart attack and stroke warning:

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, asthma, or had a stroke

    • you are taking a diuretic

    • you have problems or serious side effects from taking pain relievers or fever reducers

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    • 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

  • STOP USE AND ASK 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
    • You have symptoms of heart problems or stroke: 
        •chest pain
        •trouble breathing 
        •weakness in one part or side of body
        •slurred speech
        •leg swelling
    • 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



  • PREGNANCY/BREASTFEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20
    weeks or later in 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 every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets within the first hour
    • do not exceed 2 tablets in any 8- to 12-hour period
    • do not exceed 3 tablets in a 24-hour period
    Children under 12 years
    • ask a doctor

  • OTHER INFORMATION

    •  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)



  • INACTIVE INGREDIENT

    Inactive Ingredients 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 or Comments?

    1-877-770-3183 Mon - Fri 9:00 AM to 4:30 PM EST 

    Do not use if carton is open or of foil seal on bottle opening is missing or broken.

    Manufactured By:
    Granules India Limited
    Hyderabad –500 081, India
    MADE IN INDIA
    M.L. 37/RR/AP/2003/F/R

  • PRINCIPAL DISPLAY PANEL

    62207-728-24-carton62207-728-24-label62207-762-24-carton62207-762-24-label62207-328-51-label62207-328-51-label62207-729-24-label62207-729-24-carton62207-327-41-carton62207-327-41-label62207-761-24-carton

    62207-761-24-label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-328
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-328-4124 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    2NDC:62207-328-4250 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    3NDC:62207-328-43100 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    4NDC:62207-328-47500 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    5NDC:62207-328-491000 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135307/16/2021
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-327
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (Caplet -Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-327-4124 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    2NDC:62207-327-4250 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    3NDC:62207-327-43100 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    4NDC:62207-327-47500 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    5NDC:62207-327-491000 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135307/16/2021
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-761
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-761-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    2NDC:62207-761-43100 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    3NDC:62207-761-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    4NDC:62207-761-491000 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, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-762
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (Caplet -Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-762-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    2NDC:62207-762-43100 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    3NDC:62207-762-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
    4NDC:62207-762-491000 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:62207-728
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-728-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    2NDC:62207-728-4250 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    3NDC:62207-728-43100 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    4NDC:62207-728-47500 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    5NDC:62207-728-491000 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135306/08/2018
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-729
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (Caplet -Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-729-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    2NDC:62207-729-4250 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    3NDC:62207-729-43100 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    4NDC:62207-729-47500 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    5NDC:62207-729-491000 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135306/08/2018
    Labeler - Granules India Ltd (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236manufacture(62207-728, 62207-729, 62207-761, 62207-762, 62207-327, 62207-328)