Home > Drugs A-Z > Naproxen Sodium

Naproxen Sodium (Physicians Total Care, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE (54868-5308-0) Label Information

Complete Naproxen Sodium Information

  • SPL UNCLASSIFIED SECTION

    Compared to the active ingredient of Aleve® †

    Drug Facts


  • ACTIVE INGREDIENT

    (in each Tablet)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • PURPOSE

    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

    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 you have

    • the stomach bleeding problems apply to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have problems or serious side effects from 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 condition
    • 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 the following signs 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 feels like the pill is stuck in your throat
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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.

    Inactive ingredients

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


  • 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 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)

    Questions or Comments?

    Call 1-877-835-5472

    Monday though Friday 9AM – 5PM EST.


  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Amneal Pharmaceuticals

    Glasgow, KY 42141


    Relabeling of "Additional barcode label" by:

    Physicians Total Care, Inc.
    Tulsa, OK      74146


  • SPL UNCLASSIFIED SECTION

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

    Rev. 06-2010


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

    NDC 54868-5308-0
    Bottle of 100
    image of 220 mg package label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5308(NDC:53746-192)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Product Characteristics
    Color blue Score no score
    Shape OVAL (Biconvex) Size 12mm
    Flavor Imprint Code I7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-5308-0 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079096 05/23/2005
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel