IBUPROFEN SODIUM (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]

IBUPROFEN SODIUM (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0909-27, 0363-0909-49
Set ID f2a30365-b3dd-4360-8998-e5277d4d17b7
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA206581
  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (provided as ibuprofen sodium 256 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:

    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 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

    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, kidney disease, asthma or had a stroke
    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
  • 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
    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.

  • 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).

  • Directions

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

    each tablet contains: sodium 23 mg
    read all warnings and directions before use. Keep carton
    store at 20-25°C (68-77°F)
    avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, glyceryl monostearate, iron oxide yellow, mannitol, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Advil® (Ibuprofen Sodium) Tablets active ingredient

    Ibuprofen Sodium Tablets

    IBUPROFEN TABLETS, 200 mg (PROVIDED AS IBUPROFEN SODIUM 256 mg) / PAIN RELIEVER / FEVR REDUCER (NSAID)

    TABLETS

    ACTUAL SIZE

    40 FILM-COATED IBUPROFEN SODIUM TABLETS

    SEE NEW WARNINGS

    835-94-ibuprofen-sodium-tablets.jpg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN SODIUM 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0909
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM256 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code L1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0909-491 in 1 CARTON01/13/2016
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0909-271 in 1 CARTON01/13/2016
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20658101/13/2016
    Labeler - Walgreen Company (008965063)

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