Label: NAPROXEN ALL DAY RELIEF FOR PAIN- naproxen sodium 220 mg tablet

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

Drug Label Information

Updated December 23, 2014

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

  • Active ingredient

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

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ 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

    ■ 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 doctors care for any serious condition taking any other drug

    When using this product

    take with food or milk if stomach upset occursthe 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 immediately

  • 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 8-12 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 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F).Do not use if tamper evident seal under bottle cap is broken or missing.

  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
    stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Naproxen Tablets\LB1189.jpg
  • INGREDIENTS AND APPEARANCE
    NAPROXEN  ALL DAY RELIEF FOR PAIN
    naproxen sodium 220 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-361
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-361-5050 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054512/23/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-361) , MANUFACTURE(69168-361) , LABEL(69168-361) , PACK(69168-361) , RELABEL(69168-361) , REPACK(69168-361)