Signature care 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

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 doctors 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
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?

    1-888-723-3929

    Ingredients and appearance - Product information

    Signature care naproxen sodium tablet, film coated- Naproxen sodium

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 21130-802
    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
    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)
    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 - Safeway( 009137209)

    Principal display panel

    Compare to Aleve ®Caplets active ingredient

    Quality Guaranteed

    Naproxen Sodium TABLETS 220 mg

    Pain Reliever/Fever Reducer (NSAID)

    Strength to last 12 hours

    SEE NEW WARNINGS

    Actual Size

    PACKAGE NOT CHILD RESISTANT

    200 CAPLETS**

    **Capsule-shaped tablets