Label: MOTRIN IB MIGRAINE- ibuprofen capsule, liquid filled

  • NDC Code(s): 50580-120-20, 50580-120-80
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 3, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)1 (present as the free acid and potassium salt)


    1
    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
    • the 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. (1-800-222-1222)

  • 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). Protect from light.
    • do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
  • Inactive ingredients

    gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-120-80

    Motrin® IB
    MIGRAINE
    Ibuprofen Capsules, 200 mg
    Pain Reliever (NSAID)

    80 Liquid Filled Capsules

    Actual Size

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    MOTRIN IB MIGRAINE 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin, unspecified (UNII: 2G86QN327L)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    water (UNII: 059QF0KO0R)  
    sorbitan (UNII: 6O92ICV9RU)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (Clear) Scoreno score
    ShapeOVAL (Oblong) Size20mm
    FlavorImprint Code Motrin;IB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-120-201 in 1 CARTON01/18/2021
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50580-120-801 in 1 CARTON01/18/2021
    280 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868201/18/2021
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)