Motrin Ib Migraine

Motrin Ib Migraine
SPL v4
SPL
SPL Set ID 34818110-5291-4bda-9571-bd77d90bba7c
Route
ORAL
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Gelatin, Unspecified Polyethylene Glycol, Unspecified Potassium Hydroxide Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: Motrin;IB Shape: oval Color: white Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2021-01-18

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

Use
  • treats migraine
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20

weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child

or complications during delivery.

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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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.

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

See Revised Warning

NDC 50580-120-80

Motrin ® IB



MIGRAINE



Ibuprofen Capsules, 200 mg



Pain Reliever (NSAID)

80 Liquid Filled Capsules

Actual Size

When Using This Product
  • take with food or milk if stomach upset occurs
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
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
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
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.

Active Ingredient (in Each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)

nonsteroidal anti-inflammatory drug
(present as the free acid and potassium salt)

Medication Overuse Headache Warning

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

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

Structured Label Content

Use
  • treats migraine
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20

weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child

or complications during delivery.

Purpose

Pain reliever

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
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert (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.

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

See Revised Warning

NDC 50580-120-80

Motrin ® IB



MIGRAINE



Ibuprofen Capsules, 200 mg



Pain Reliever (NSAID)

80 Liquid Filled Capsules

Actual Size

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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
Heart Attack and Stroke Warning (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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)

nonsteroidal anti-inflammatory drug
(present as the free acid and potassium salt)

Medication Overuse Headache Warning (Medication overuse headache warning)

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

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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