NAPROXEN SODIUM TABLET [WAL-MART STORES, INC.,]

NAPROXEN SODIUM TABLET [WAL-MART STORES, INC.,]
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NDC 49035-761-21, 49035-762-10, 49035-762-21, 49035-762-24, 49035-762-30
Set ID 3d963242-a7b5-1ea4-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc.,
Generic Name
Product Class
Product Number
Application Number ANDA091353
  • Active ingredient

    (in each caplet)
    Naproxen sodium 220 mg (NSAID)**

    **nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever/Fever reducer

  • Uses

    • 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 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 the 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 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 20 - 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • Questions and comments?

    1-888-287-1915

  • 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.

  • PRINCIPAL DISPLAY PANEL

    24 count

  • PRINCIPAL DISPLAY PANEL

    100 count

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-762
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-762-2424 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    2NDC:49035-762-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    3NDC:49035-762-21225 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    4NDC:49035-762-30300 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135305/25/2016
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-761
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-761-21225 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135305/25/2016
    Labeler - Wal-Mart Stores, Inc., (051957769)

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