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Ibuprofen (New World Imports)

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TABLET 100 TABLET in 1 BOTTLE (51824-018-10) Label Information

Complete Ibuprofen Information

  • ACTIVE INGREDIENT

    Ibuprofen 200mg  (NSAID)**

    **nonsteroidal anti-inflammatory drug


  • PURPOSE

    Pain reliever / fever reducer


  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)


  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains due to:

    Headache, muscular aches, minor pain of arthritis, toothache, backache, common cold and menstrual cramps

    Temporarily reduces fever



  • WARNINGS

    Allergy alert:Ibuprofen 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, seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.  The chance is higher if you:

    Are 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen,  naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed.

    Do not use if you have ever had a n allergic reaction to any other pain reliever / fever reducer or right before / after heart surgery.

    Ask a doctor before use if you have: problems or serious side effects from taking pain relievers or fever reducers.  The stomach bleeding warning applies to you.  You haev a history of stomach problems, such as heartburn, you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.  You have asthma.  You are taking a diuretic.

    Ask a doctor or pharmacist before use if you are:taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin.  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 of 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.  Redness or swelling is present in the painful area.  Any new symptoms appear.

    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.


  • DOSAGE & ADMINISTRATION

    Do not take more than directed.  The smallest effective dose should be used. 

    Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablets, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours unless directed by a doctor.

    Children under 12 years: ask a doctor


  • INACTIVE INGREDIENT

    colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, pregelantinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin


  • OTHER SAFETY INFORMATION

    Store between 20-25 degrees celcius (68-77 degrees farhenheit).

    Read all warnings and directions before use

    Do not use if seal under bottle cap is broken or missing


  • QUESTIONS

    Questions or Comments: Call 1-888-952-0050  Monday through Friday 9 AM - 5 PM EST


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-018
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color brown (Rusty brown color) Score no score
    Shape ROUND (Round) Size 10mm
    Flavor Imprint Code IBU200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-018-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2012 08/01/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/05/2012 08/01/2020
    Labeler - New World Imports (075372276)