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Naproxen Sodium (Rugby Laboratories Inc)

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TABLET 50 TABLET in 1 BOTTLE (0536-4113-06) Label Information

Complete Naproxen Sodium Information

  • ACTIVE INGREDIENT

    (in each caplet)

    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 Doctor before use if

    • 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.


  • 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 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8- to 12-hour period
    • do not exceed 3 caplets in a 24-hour period
     Children under 12 years  
    • ask a doctor

    Other information
    • each caplet contains: sodium 20 mg
    • store at 20 to 25°C (68 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)
    • read all warnings and directions before use. Keep carton.
    • do not use if inner seal under bottle cap imprinted wiht "Sealed for Your Protection" is broken or missing

    Inactive ingredients

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

    Questions or Comments?

    Call 1-800-645-2158  9am–5pm ET, Monday-Friday


  • PRINCIPAL DISPLAY PANEL

    Compare to Active ingredient in Aleve®**

    **Rugby Laboratories, Inc. is not affiliated wiht the owner of the trademark Aleve®.

    Rugby Naproxen Sodium 220 mg is distributed by Rugby Laboratories, Inc.

    Rugby® Duluth, Georgia  30097

    www.rugbylaboratories.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION


  • Product Label

     Rubgy Naproxen Sodium 220 mg 50ct

    Naproxen Sodium 220 mg


  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4113(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
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 13mm
    Flavor Imprint Code I7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-4113-06 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079096 11/25/2009
    Labeler - Rugby Laboratories Inc (109178264)