Label: NAPROXEN SODIUM capsule, liquid filled

  • NDC Code(s): 69452-179-11, 69452-179-15, 69452-179-20, 69452-179-22, view more
    69452-179-78, 69452-179-79
  • Packager: Bionpharma Inc.

Drug Label Information

Updated February 4, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.


    Drug Facts

  • Active ingredients (in each capsule)

    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

    • 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 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
    • slurred speech
    • weakness in one part or side of body
    • leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • you have difficulty swallowing
    • it feels like the capsule is stuck in your throat

    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.

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • drink a full glass of water with each dose
    • if taken with food, this product may take longer to work
    adults and children 12 years and older:
    • take 1 capsule every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 capsules within the first hour
    • do not exceed 2 capsules in any 8- to 12-hour period
    • do not exceed 3 capsules in a 24-hour period
    children under 12 years:
    • ask a doctor
  • Other information

    • each capsule contains: sodium 20 mg
    • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    • protect from light
    • read all directions and warnings before use.
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

  • Questions or comments?

    1-888-235-2466 (Mon – Fri 9AM – 5PM EST)


    Do not use if printed safety seal under cap is torn or missing.

    ***This product is not manufactured or distributed by the owners of ALEVE ® Liquid Gels.

    Manufactured for:


    600 Alexander Road,

    Princeton, NJ 08540



  • PRINCIPAL DISPLAY PANEL - 120's bottle label

    220 mg 20's Bottle Carton

    naproxen sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-179
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (Blue with white text) Scoreno score
    FlavorImprint Code NP1
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-179-79160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201811/01/2018
    2NDC:69452-179-1120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201811/01/2018
    3NDC:69452-179-1540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201811/01/2018
    4NDC:69452-179-7880 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201811/01/2018
    5NDC:69452-179-20100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201811/01/2018
    6NDC:69452-179-22120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-179)