Label: NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER- naproxen sodium tablet

  • NDC Code(s): 53746-191-05, 53746-191-08, 53746-191-24, 53746-192-05, view more
    53746-192-08, 53746-192-24
  • Packager: Amneal Pharmaceuticals of New York LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Compared to the active ingredient of Aleve® †

    Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Naproxen sodium USP, 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • INDICATION AND USAGE

    Uses

    • temporarily relieves minor aches and pains 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

    Heart attack and stroke warning: NSAID, 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 DOCTOR/PHARMACIST

    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 doctor’s care for any serious condition
    • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
    • taking any other drug
  • WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs
  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    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

    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 older 
    • 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-hour period
     Children under 12 years 
    • ask a doctor

    Other information

    • each tablet contains: sodium 20 mg
    • store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • INACTIVE INGREDIENT

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

  • Questions or Comments?

    Call 1-877-835-5472

    Monday through Friday 9 AM – 5 PM EST.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Amneal Pharmaceuticals LLC

    Bridgewater, NJ  08807

  • SPL UNCLASSIFIED SECTION

    †This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

    Rev. 05-2022-03

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 53746-191-24

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    24 Tablets

    Amneal Pharmaceuticals LLC

    01

    NDC 53746-192-24

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    24 Caplets

    Amneal Pharmaceuticals LLC

    02

    NDC 53746-191-24

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    24 Tablets

    Amneal Pharmaceuticals LLC

    03

    NDC 53746-192-24

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    24 Caplets

    Amneal Pharmaceuticals LLC

    04

    Purse Pack

    NDC 53746-191-08

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    8 Tablets

    Amneal Pharmaceuticals LLC

    1

    Purse Pack

    NDC 53746-192-08

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    8 Caplets

    Amneal Pharmaceuticals LLC

    1

    Purse Pack

    NDC 53746-191-16

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    16 Tablets

    Amneal Pharmaceuticals LLC

    1

    04

    Purse Pack

    NDC 53746-192-16

    Naproxen Sodium Tablets USP (NSAID), 220 mg

    16 Caplets

    Amneal Pharmaceuticals LLC

    1
    06

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53746-191
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUND (Biconvex) Size10mm
    FlavorImprint Code I3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53746-191-2424 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2009
    2NDC:53746-191-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2009
    3NDC:53746-191-088 in 1 VIAL; Type 0: Not a Combination Product11/25/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909611/25/2009
    NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53746-192
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, 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:53746-192-088 in 1 VIAL; Type 0: Not a Combination Product11/25/2009
    2NDC:53746-192-2424 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2009
    3NDC:53746-192-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909611/25/2009
    Labeler - Amneal Pharmaceuticals of New York LLC (123797875)
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