Label: EQUALINE NAPROXEN SODIUM- naproxen sodium tablet, film coated

  • NDC Code(s): 41163-511-62, 41163-511-71, 41163-511-78
  • Packager: Supervalu Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 22, 2018

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

  • 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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, asthma, or had a stroke
    you are taking a diuretic
    you have problems or serious side effects from taking pain relievers or fever reducers

    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

    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
    you have symptoms of heart problems or stroke:
    chest pain
    trouble breathing
    weakness in one part or side of body
    slurred speech
    leg swelling
    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?

    1-877-932-7948

  • Principal Display Panel

    compare to Aleve® active ingredient

    naproxen sodium tablets 220mg

    pain reliever/ fever reducer (NSAID)

    strength to last 12 hours

    SEE NEW WARNINGS

    50 caplets**

    **capsule-shaped tablets

    actual size

    368EL-naproxen-sodium.jpg
  • INGREDIENTS AND APPEARANCE
    EQUALINE NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-511
    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
    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)  
    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:41163-511-711 in 1 CARTON09/24/2014
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41163-511-621 in 1 CARTON09/24/2014
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41163-511-781 in 1 CARTON09/24/2014
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07466109/24/2014
    Labeler - Supervalu Inc (006961411)