Label: ADVIL- ibuprofen tablet, coated

  • NDC Code(s): 52904-786-50, 52904-790-30, 52904-791-25, 52904-794-01, view more
    52904-794-02, 52904-794-05, 52904-794-06
  • Packager: Wyeth Pharmaceuticals Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 29, 2019

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Advil Tablets (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Advil Caplets (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Advil Gel Caplets (in each gel caplet)

    Ibuprofen 200 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 non-prescription 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.

  • DIRECTIONS

    Advil Tablets

    • 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

    Advil Caplets

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor

    Advil Gel Caplets

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
    • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
  • OTHER INFORMATION

    • 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

    Advil Tablets

    acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

    Advil Caplets

    acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

    Advil Gel Caplets

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin

    Questions or comments?

    call toll free 1-800-88-ADVIL

  • HOW SUPPLIED

    Product: 52904-794

    NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON

    NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK

    NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK

    NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON

    Product: 52904-786

    NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE

    Product: 52904-790

    NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE

    Product: 52904-791

    NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE

  • IBUPROFEN

    Label Image
  • ADVIL (IBUPROFEN) TABLET, COATED

    Label Image
  • ADVIL (IBUPROFEN) TABLET, COATED

    Label Image
  • ADVIL (IBUPROFEN)

    Label Image
  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-791
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-791-2525 in 1 CASE01/01/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-790
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-790-3030 in 1 CASE05/29/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-786
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-786-5050 in 1 CASE05/29/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-794
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-794-051 in 1 CARTON01/01/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:52904-794-011 in 1 BLISTER PACK01/01/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:52904-794-022 in 1 BLISTER PACK01/01/2017
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:52904-794-062 in 1 CARTON01/01/2017
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    Labeler - Wyeth Pharmaceuticals Company (053805599)
    Establishment
    NameAddressID/FEIBusiness Operations
    Select Corporation829390975manufacture(52904-794, 52904-786, 52904-790, 52904-791)