Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated October 16, 2012

If you are a consumer or patient please visit this version.

  • Active ingredient (in each brown tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • Temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
      • minor pain of arthritis
    • Temporarily reduces fever
  • Warnings

    Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • shock
    • hives
    • facial swelling
    • asthma (wheezing)
    • 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

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

    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
      ibuprofen may decrease this benefit of aspirin
    • 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
    • redness or swelling is present in the painful area
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use. it is especially important not to use ibuprofen 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 use more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • adults and children 12 years and over: take 1 tablet
      every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets
      may be used
    • do not take more than 6 tablets in 24 hours unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • store at controlled room temperature
    • avoid excessive heat 40°C (104°F)
  • Inactive ingredients

    carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

    Questions or comments?

    Call 1-800-540-3765

  • Package label

    Ibuprofen 200mg

    SEE NEW WARNINGS

    IBUPROFEN

    pain reliever/fever reducer (NSAID)

    COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*

    100 Tablets

    200 mg each

    Tamper Evident:

    Do not use if imprinted seal under cap is missing or broken.

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-315(NDC:57896-941)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-315-2020 in 1 BOTTLE
    2NDC:42254-315-2828 in 1 BOTTLE
    3NDC:42254-315-3030 in 1 BOTTLE
    4NDC:42254-315-4040 in 1 BOTTLE
    5NDC:42254-315-5050 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501001/01/2004
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    NameAddressID/FEIBusiness Operations
    PSS World Medical, Inc.791528623REPACK(42254-315)
    Establishment
    NameAddressID/FEIBusiness Operations
    STAT RX USA LLC786036330REPACK(42254-315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785RELABEL(42254-315) , REPACK(42254-315)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCRIPT PAK964420108RELABEL(42254-315) , REPACK(42254-315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals, Inc.362861077REPACK(42254-315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distirbutors Corp.118802834RELABEL(42254-315) , REPACK(42254-315)