Label: IBUPROFEN MIGRAINE- ibuprofen capsule, liquid filled

  • NDC Code(s): 69842-892-11, 69842-892-78
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 20, 2021

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

  • Active ingredient (in each orange 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

  • Uses

    • 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 warnings and directions before use. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F). Protect from light.
  • Inactive ingredients

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

  • Questions or comments?

    call toll free 1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS
    V-38090

    CVS ®Quality

    Money Back Guarantee

    All trademarks are property of their respective owners. This
    product is not affiliated with the owners of Motrin ® IB Migraine.

  • 80's Count Carton

    CVSHealth ®

    Compare to the active

    ingredient in Motrin ® IB Migraine

    Liquid-Filled Capsules

    NDC 69842-892-78

    Ibuprofen

    Migraine

    IBUPROFEN CAPSULES, 200 mg

    Pain reliever (NSAID)

    80 SOFTGELS**

    **Liquid-Filled Capsules

    Actual Size

    Package contains One Bottle

    Carton Image

    80count-carton

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN MIGRAINE 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-892
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (Dye free) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code IB5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-892-111 in 1 CARTON10/20/2021
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-892-781 in 1 CARTON10/20/2021
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868210/20/2021
    Labeler - CVS Pharmacy (062312574)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69842-892)