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Pill Identifier Information of naproxen sodium 220 MG (naproxen 200 MG) Oral Tablet

Drug Information

naproxen sodium 220 MG (naproxen 200 MG) Oral Tablet

Imprint: I7
Shape: C48345
Color: C48333
Ingredients: Naproxen
Size: 12.00
Score: 1
Rxtty: SY
Author: AAA Pharmaceutical, Inc.
Inactive Ingredients: CROSCARMELLOSE SODIUM / FD&C BLUE NO. 2 / POLYETHYLENE GLYCOLS / MAGNESIUM STEARATE / POLYVINYL ALCOHOL / POVIDONES / STARCH, CORN / TALC / TITANIUM DIOXIDE>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    When using this product

    Stop use and ask a doctor if

    â–  you experience any of the following signs of stomach bleeding:
    â–  feel faint
    â–  vomit blood
    â–  have bloody or black stools
    â–  have stomach pain that does not get better
    â–  you have symptoms of heart problems or stroke:
    â–  chest pain
    â–  trouble breathing
    â–  weakness in one part or side of body
    â–  slurred speech
    â–  leg swelling
    â–  pain gets worse or lasts more than 10 days
    â–  fever gets worse or lasts more than 3 days
    â–  you have difficulty swallowing
    â–  it feels like the pill is stuck in your throat
    â–  redness or swelling is present in the painful area
    â–  any new symptoms appear

    If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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. (1-800-822-1222)

  • Directions

    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

  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    RESTOREU

    NDC 57344-145-01

    †COMPARE TO THE ACTIVE INGREDIENT IN ALEVE®

    Naproxen Sodium

    Tablets, 220 mg

    Pain Reliever/Fever Reducer

    (NSAID)

    Strength to last 12 hours

    actual size

    24 CAPLETS**

    **CAPSULE-SHAPED TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-145
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (Biconvex) Size12mm
    FlavorImprint Code I7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-145-011 in 1 CARTON04/01/2012
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909604/01/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)