Label: NAPROXEN SODIUM 220MG tablet, coated

  • NDC Code(s): 69168-395-07, 69168-395-17, 69168-395-50
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 21, 2021

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

  • Active ingredient(s)

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

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Use(s)

    temporarily relieves minor aches and pains due to:

    • headache
    • minor pain of arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • toothache
    • the common cold
    • temporarily reduces fever
  • Warnings

    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

    under a doctor’s care for any serious condition 

    • taking aspirin for heart attack or stroke, because naproxen may
      decrease this benefit of aspirin
    • 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

    Pregnancy/Breastfeeding

    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

    Other 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

  • 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 20 mg
    • do not use if tamper evident seal under bottle is broken or missing
  • Storage

    • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • Inactive ingredients

    Inactive ingredients FD&C blue #2 aluminum
    lake, hypromellose, microcrystalline cellulose,
    polyethylene glycol, povidone, titanium dioxide
    May contain: corn starch, croscarmellose sodium,
    magnesium stearate, purified water, silicon

  • Questions

    Call 1-888-952-0050 Monday through Friday 9AM- 5PM EST.

  • Principal Display Panel

    Naprozen

    Naproxen



  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 220MG 
    naproxen sodium 220mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-395
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-395-17300 in 1 BOTTLE; Type 0: Not a Combination Product04/21/2021
    2NDC:69168-395-5050 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
    3NDC:69168-395-0710 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/04/2011
    Labeler - Allegiant Health (079501930)