Label: NAPROXEN tablet

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

Drug Label Information

Updated October 15, 2015

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  • DESCRIPTION

    Each capsule contains:

    Naxproxen, ESP ..........500 mg

  • DESCRIPTION

    Dosage and Use: For dosage recommendations

    and other important prescribing information, read accompanying insert.

  • STORAGE AND HANDLING

    Store at 20 to 25 C (68 to 77 F); excursions

    permitted to 15 to 30 C (59 to 86 F)[See

    USP Controlled Room Temperature]

    Dispense in well-closed, light-resistant containers

    as defined in the USP.  

  • BOXED WARNING (What is this?)

    BOXED WARNING

    Cardiovascular Risk

    -NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,

    myocardial infarction, and stroke, which can be fatal.

    -Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri-operative

    pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

    Gastrointestinal Risk

    -NSAIDs may cause an increased risk of serious gastrointestinal adverse events including

    bleeding, ulceration. and perforation of the stomach or intestines, which can be fatal.

  • DESCRIPTION

    DESCRIPTION

    Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.


  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

    Pharmacodynamics - Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and

    antipyretic properties.

  • CLINICAL STUDIES

    CLINICAL STUDIES

    General Information - Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis,

    juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE

    Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatments

    before deciding to sue naproxen tablets, USP.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP.

  • WARNINGS

    WARNINGS

    Cardiovascular Effects - Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective

    and non-selective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV)

    thrombotic events, myocardial infarction, and stroke, which can be fatal.

  • PRECAUTIONS

    PRECAUTIONS

    General - Naproxen - containing products such as naproxen tablets, and other naproxen products should

    not be used concomitantly since they all circulate in the plasma as the naproxin anion.


  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis

    or osteoarthritis are listed below.

  • OVERDOSAGE

    OVERDOSAGE

    Symptoms and Signs   Significant naproxen overdosage may be characterized by lethargy, dizziness,

    drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function,

    hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment

    options before deciding to use naproxen tablets, USP.

  • PATIENT MEDICATION INFORMATION

    MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)

    (See the end  of this Medication Guide for a list of prescription NSAID medicines.)

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN 
    naproxen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69512-190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN500 mg  in 500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONES (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code IP190;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-190-10100 in 1 BOTTLE
    1500 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07592710/01/2015
    Labeler - Alivio Medical Products, LLC (079670828)
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