NAPROXEN SODIUM TABLET [DIRECT RX]

NAPROXEN SODIUM TABLET [DIRECT RX]
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NDC 61919-470-40
Set ID 6738420f-5ea9-470f-e053-2a91aa0a1adc
Category HUMAN OTC DRUG LABEL
Packager DIRECT RX
Generic Name
Product Class
Product Number
Application Number ANDA090545
  • ACTIVE INGREDIENT

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

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/ fever reducer

  • WHEN USING

    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 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 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.

  • WHEN USING

    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 AND HANDLING

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

  • INACTIVE INGREDIENT


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

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    470-40

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-470(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)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-470-4040 in 1 BOTTLE; Type 0: Not a Combination Product03/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054503/06/2018
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-470)

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