Label: ADVIL MIGRAINE- ibuprofen capsule, liquid filled

  • NDC Code(s): 0573-0168-20, 0573-0168-30, 0573-0168-40
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 11, 2020

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

  • ACTIVE INGREDIENT (IN EACH BROWN OVAL CAPSULE)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever

  • USE

    treats migraine
  • 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.

    Medication overuse headache warning

    Headaches may worsen if this product is used for 10 or more days per month.

    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

    you have never had migraines diagnosed by a health professional
    you have a headache that is different from your usual migraines
    you have the worst headache of your life
    you have fever and stiff neck
    you have headaches beginning after or caused by head injury, exertion, coughing or bending
    you have experienced your first headache after the age of 50
    you have daily headaches
    you have a migraine so severe as to require bed rest
    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
    migraine headache pain is not relieved or gets worse after the first dose
    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

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

    adults

    take 2 capsules with a glass of water
    if symptoms persist or worsen, ask your doctor
    do not take more than 2 capsules in 24 hours, unless directed by a doctor

    under 18 years of age

    ask a doctor
  • OTHER INFORMATION

    each capsule contains: potassium 20 mg
    read all directions and warnings before use. Keep carton.
    store at 20-25°C (68-77°F)
    avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS

    D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

  • QUESTIONS OR COMMENTS?

    Call toll-free 1-800-88-ADVIL

  • PRINCIPAL DISPLAY PANEL

    Advil®
    MIGRAINE

    Solubilized Ibuprofen Capsules, 200 mg
    Pain Reliever (NSAID)

    80
    Liquid Filled
    Capsules

    PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL MIGRAINE 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBROWN (translucent brown) Scoreno score
    ShapeOVAL (soft gelatin capsule) Size17mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0168-201 in 1 CARTON03/16/2000
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0168-301 in 1 CARTON03/16/2000
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0168-401 in 1 CARTON03/16/2000
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040203/16/2000
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0168) , LABEL(0573-0168) , MANUFACTURE(0573-0168) , PACK(0573-0168)