GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [PROFICIENT RX LP]

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GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [PROFICIENT RX LP]
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NDC 63187-794-20, 63187-794-30, 63187-794-60
Set ID c0dc7f87-355c-4357-b99d-f03693d350a7
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number ANDA074661
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  • Active ingredient (in each caplet)

     
    Naproxen sodium 220 mg
     
    (naproxen 200 mg) (NSAID)*
     
    *nonsteroidal anti-inflammatory drug
  • Purposes

    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 reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • 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 21 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 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Strength To Last 12 Hours

    Naproxen Sodium Tablets, 220 mg

    Actual Size

    Pain Reliever & Fever Reducer (NSAID)

    Compare to active ingredient of Aleve® Caplets

    20 Caplets†

    †Capsule-Shaped Tablets

    63187-794-20
    Naproxen Sodium Tablets, 220 mg Carton 2
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-794(NDC:0113-4368)
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code L368
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-794-2020 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2016
    2NDC:63187-794-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2016
    3NDC:63187-794-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07466103/31/2014
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-794)
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