NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC]

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NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC]
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NDC 68210-0040-0
Set ID fbb27242-8ec6-453f-b2f1-de0b28492c57
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS,LLC
Generic Name
Product Class
Product Number
Application Number ANDA091353
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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
    • headache
    • menstrul cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Allergy alert

    Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • asthma (wheezing)
    • blisters
    • facial swelling
    • hives
    • rash
    • shock
    • skin reddening

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning

    This product contains a non steroidal anti-inflammatory drug(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

    NSAID's except aspirin increases 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 surgery
  • Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems,such as a heartburn
    • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you are taking a diuretic
    • you have problems or serious side effects taking pain relievers or fever reducers
    • you have asthma
  • Ask a doctor or pharmacist before use if you are

    • under a doctor 's care for any serious conditions
    • 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 following sign 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 feel like the pill is stuck in your throat
    • redness or swelling is present in the painful area
    • any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a position 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
     Adults and Children 12 years and older:
    • take one tablet every 8 to 12 hours while symptoms last
    • for the first dose you may take within the first hour
    • do not exceed 2 tablets in any 8 to 12 hours period
    • do not exceed 3 tablets in 24 hour period
     Children under 12 years:
    •  Ask a doctor

  • Other information

    • each tablet contains: sodium 20 mg
    • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
  • Inactive ingredients

    Colloidal silicon dioxide*, croscarmellose sodium*, FD&C Blue#2 lake, hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.

    *contains one or more of these ingredients

  • SPL UNCLASSIFIED SECTION

    Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

  • PRINCIPAL DISPLAY PANEL

    ASSURED™

    SEE NEW WARNINGS INFORMATION

    Compare to the active
    ingredient in Aleve®*

    ALL DAY
    PAIN RELIEF

    NAPROXEN SODIUM TABLETS, USP 220 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    STRENGTH TO LAST 12 HOURS

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0040
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0040-01 in 1 CARTON12/22/2017
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68210-0040-11 in 1 CARTON04/06/2020
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135312/22/2017
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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