IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]

IBUPROFEN TABLET, FILM COATED [CARDINAL HEALTH]
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NDC 55154-0669-0
Set ID 260f5862-d65d-4c34-bf53-26ca30806a67
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number ANDA075139
  • DRUG FACTS

  • ACTIVE INGREDIENT

    (in each white tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USES

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

    Read all warnings and directions before use.

    SEE NEW WARNINGS INFORMATION

    This unit dose package is not child resistant and is intended for institutional use only.

    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, stop use and 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 age 60 or older
    have had stomach ulcers or bleeding problems
    take a blood thinning (anticoagulant) or steroid drug
    take other drugs containing an 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

    Heart attack and stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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

    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 or kidney disease
    you are taking a diuretic
    you have asthma or had a stroke

    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

    Stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding:.
    feel faint
    have bloody or black stools
    vomit blood
    have stomach pain that does not get better
    you have symptoms of heart problems or stroke
    chest pain
    Slurred speech
    Leg swelling
    Trouble breathing
    Weakness in one part or side of body
    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

    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 (1-800-222-1222) right away. 

  • DIRECTIONS

    do not take more than directed
    the smallest effective dose must be used

    DOSAGE & ADMINISTRATION SECTION

    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 exceed 6 tablets in 24 hours, unless directed by a doctor
    Children under 12 years: ask a doctor
  • OTHER INFORMATION

    STORAGE: Store between 20-25ºC (68º-77ºF); Avoid excessive heat 40C (104F)

    TAMPER EVIDENT: DO NOT USE IF BLISTER IS TORN OR BROKEN

  • INACTIVE INGREDIENTS

    corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

    Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

    Distributed By:

    Major® Pharmaceuticals

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152 USA

    MFGD By LNK, Hauppauge, NY 11788

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L3432333-10318

    L3432333-20318

  • Principal Display Panel

    Ibuprofen Tablets, USP 200 mg.

    Pain Reliever/Fever Reducer (NSAID)

    10 Tablets

    bag label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0669(NDC:0904-7914)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;438
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-0669-010 in 1 BAG06/03/2011
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513906/03/2011
    Labeler - Cardinal Health (603638201)

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