Label: IBUPROFEN 200MG tablet, film coated

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

Drug Label Information

Updated October 31, 2022

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

  • Directions

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

    Adults and children 12 years and older:

    • 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

  • 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, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold menstrual cramps temporarily reduces fever
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • Purposes

    Pain reliever/fever reducer

  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory dru

  • Don not use

    • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    • right before or 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 have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
  • Ask a doctor or pharmacist before use if you are

    • taking aspirin for 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
  • Stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding:

    • feel faint
    • vomitblood
    • have bloody or black stools
    • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke: chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • 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.

  • Other information

    • read all warnings and directions before use
    • store at 20-25°C (68-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
  • Ibuprofen 200mg 50 Tablets

    Ibuprofen

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 200MG 
    ibuprofen 200mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-693(NDC:0904-6747)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-693-5050 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209610/31/2022
    Labeler - Southern Sales & Services, Inc. (013114906)