Healthy accents naproxen sodium tablet, film coated

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

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

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 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 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
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 periodask a doctor

    Adults and children 12 years and older

    Children under 12 years

    Other information

    • each caplet contains: sodium 21 mg
    • store at 20-25C (68-77F). Avoid high humidity and excessive heat above 40C (104F).

    Inactive ingredients

    FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

    Questions or comments?

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    Ingredients and appearance - Product information

    Healthy accents naproxen sodium tablet, film coated- Naproxen sodium

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55316-140
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Naproxen sodium ( UNII: 9TN87S3A3C)( Naproxen - UNII: 57Y76R9ATQ ) 220 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Hypromellose, unspecified ( UNII: 3NXW29V3WO)
    Magnesium stearate ( UNII: 70097M6I30)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
    Povidone, unspecified ( UNII: FZ989GH94E)
    Talc ( UNII: 7SEV7J4R1U)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color BLUE (light blue) Size 12 mm
    Shape OVAL Score 1
    Imprint Code L368

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA074661 USA

    Labeler - DZA Brands LLC( 090322194)

    Principal display panel

    strength to last 12 hours

    naproxen sodium tablets, 220mg

    pain reliever fever reducer (NSAID)

    Compare to Aleve® active ingredient

    PACKAGE NOT CHILD RESISTANT

    actual size

    200 caplets**

    **capsule-shaped tablets