Label: NAPROXEN SODIUM tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 1, 2019

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  • Active ingredient (in each tablet)

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

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/ fever reducer

  • Uses

    temporarily relieves minor aches and pain due to:

    •
    backache
    •
    muscular aches
    •
    minor pain of arthritis
    •
    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

    •
    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 doctor if

    •
    you experience any of the following signs of stomach bleeding:
    •
    feel faint
    •
    vomit blood
    •
    have bloody or black stools
    •
    have a stomach pain that dose 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
  • PREGNANCY OR BREAST FEEDING

    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 every 8 to12 hours while symptoms last
    •
    for first dose you may take 2 tablets with in 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
  • Storage

     

    •
    Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)
  • Other information

    •
    each tablet contains: sodium 20 mg
    •
    If side effects occur, you may report side effects to
    FDA at 1-800-FDA-1088
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

     

  • Questions or comments?

    Call 1-800-540-3765

  • Principal Display Panel

    63187-986-24

    Repackaged by:

    Proficient Rx LP

    Thousand Oaks CA. 91320

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-986(NDC:57896-951)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-986-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    2NDC:63187-986-2424 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    3NDC:63187-986-2828 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    4NDC:63187-986-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    5NDC:63187-986-5050 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    6NDC:63187-986-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/01/2012
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-986) , RELABEL(63187-986)
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