Naproxen sodium tablet

Active ingredient (in each tablet)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • 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

  • 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 doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have a stomach pain that dose 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

Otc - pregnancy or breast feeding section

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 takemore than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
take 1 tablet every 8 to12 hours while symptoms last
  • for first dose you may take 2 tablets with in 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


    ask a doctor

    Adults and children 12 years and older:

    Children under 12 years:

    Storage

    • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 C (104 F)

    Other information

    • each tablet contains:sodium 20 mg
    • If side effects occur, you may report side effects to
      FDA at 1-800-FDA-1088

    Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

    Questions or comments?

    Call 1-800-540-3765

    Ingredients and appearance - Product information

    Naproxen sodium tablet- Naproxen sodium

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68788-7367
    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
    Silicon dioxide ( UNII: ETJ7Z6XBU4)
    Croscarmellose sodium ( UNII: M28OL1HH48)
    Fd&c blue no. 2 ( UNII: L06K8R7DQK)
    Hypromellose, unspecified ( UNII: 3NXW29V3WO)
    Magnesium stearate ( UNII: 70097M6I30)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
    Povidone, unspecified ( UNII: FZ989GH94E)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color blue Size 12 mm
    Shape OVAL Score 1
    Imprint Code 144

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA090545 USA

    Labeler - Preferred Pharmaceuticals Inc.( 791119022)

    Establishment

    Name ID/FEI Business Operations
    Preferred Pharmaceuticals Inc. 791119022 REPACK( 68788-7367)

    Principal display panel