Motrin IB Migraine IBUPROFEN KENVUE BRANDS LLC FDA Approved Use treats migraine
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Substance Ibuprofen
Route
ORAL
Applications
ANDA078682

Drug Facts

Composition & Profile

Active Ingredients
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)
Inactive Ingredients
Inactive ingredients gelatin pharmaceutical ink polyethylene glycol potassium hydroxide purified water sorbitan and sorbitol
Strengths
200 mg
Treats Conditions
Use Treats Migraine
Pill Appearance
Shape: oval Color: white Imprint: Motrin;IB

Identifiers & Packaging

Container Type UNKNOWN
UPC
0300450916808
UNII
WK2XYI10QM
Packaging

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 motrin-1

Package Descriptions
  • 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 motrin-1

Overview

Use treats migraine

Indications & Usage

Use treats migraine

Dosage & Administration

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

Warnings & Precautions
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 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. 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)
Purpose

Purpose Pain reliever

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

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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)

Storage & Handling

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

Questions

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


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