Label: ALL DAY PAIN RELIEF- naproxen sodium tablets, 220 mg tablet

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

Drug Label Information

Updated February 10, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purposes
    *
    *
    Naproxen Sodium 220 mg 
    (naproxen 200 mg) (NSAID)*Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

  • Uses

    ■ temporarily relieves minor aches and pains due to:

      ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache

      ■ menstrual cramps ■ 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

    ■ 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

      ■ take 1 tablet every 8 to 12 hours while symptoms last 12 years and older

      ■ for the first dose you may take 2 tablets within 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

  • Other information

    each tablet contains: sodium 20 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#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information & Directions

    Compare to the Active Ingredients in Aleve®.

    ALL DAY PAIN RELIEF

    Naproxen Sodium Tablets, 220 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    ALL DAY PAIN RELIEF 
    naproxen sodium tablets, 220 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeOVAL (Capsule-Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-008-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-008-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-008-022 in 1 POUCH
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135309/30/2011
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(70005-008)