Label: NAPROXEN SODIUM tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 9, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT(S)

    (in each tablet)
    Naproxen sodium 220mg
    (naproxen 200mg) (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/Fever reducer

  • USE(S)

    ■ 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

    ■ 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

  • 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 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 of swelling is present in the painful area
    ■ any new symptoms appear
    You may report side effects to FDA at 1-800-FDA-1088

  • PREGNANCY/BREASTFEEDING

    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


    Adults and
    children 12 years
    and over
    ■ take 1 tablet every 8 to
          12 hours while symptoms last
    ■ for the first dose you may take
          2 tablets within the first hour
    ■ do not exceed 2 tablets in any
          8- to 12-hour period
    ■ do not exceed 3 tablets in a
          24-hr period
    Children under 12 years
    ■ ask a doctor


  • OTHER INFORMATION


    ■ each tablet contains: sodium 20mg
    ■ store at 20 to 250C (68 to 770F). Avoid high
    humidity and excessive heat above 400C (1040F).


  • INACTIVE INGREDIENTS

    FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide

  • QUESTIONS OR COMMENTS

    888-588-1418 (MON - FRI 9 AM to 5 PM EST)

    Distributed By: Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA



  • Naproxen sodium

    Label Image
  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4704(NDC:69230-313)
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ET10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4704-030 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20761212/11/2019
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4704) , REPACK(50090-4704)