Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated January 18, 2024

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

View All Sections
  • 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

    L3432333-10124

    L3432333-20124

  • 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 107, LLC (118546603)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!