Sign In

Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"

You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.

View Generic:
View Brand:

Advil migraine - Prescription Drug Labeling

Product NDC Code 0573-0168
Drug Name

Advil migraine

Type Brand
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Ibuprofen 200 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 310964,
731533
Application Number NDA020402
Labeler Name GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Packages
Package NDC Code Description
0573-0168-20 1 bottle in 1 carton (0573-0168-20) > 20 capsule, liquid filled in 1 bottle
0573-0168-30 1 bottle in 1 carton (0573-0168-30) > 40 capsule, liquid filled in 1 bottle
0573-0168-40 1 bottle in 1 carton (0573-0168-40) > 80 capsule, liquid filled in 1 bottle

Active ingredient

A list of the active, medicinal ingredients in the drug product.
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

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use • treats migraine

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever

Spl product data elements

Usually a list of ingredients in a drug product.
ADVIL MIGRAINE ibuprofen IBUPROFEN IBUPROFEN D&C YELLOW NO. 10 FD&C GREEN NO. 3 FD&C RED NO. 40 GELATIN, UNSPECIFIED LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL translucent brown soft gelatin capsule Advil

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL NDC 0573-0168-20 Advil MIGRAINE Solubilized Ibuprofen Capsules, 200 mg Pain Reliever (NSAID) 20 Liquid Filled Capsules 000068423 Front Carton Advil Migraine (200 mg) 20ct Capsules

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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) Additional Information READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. For most recent product information, visit www.Advil.com Dist. by: GSK CH, Warren, NJ 07059 ©2021 GSK or licensor Trademarks owned or licensed by GSK

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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 doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? Call toll-free 1-800-88-ADVIL

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product • take with food or milk if stomach upset occurs

Pregnancy or breast feeding

Pregnancy or Breast feeding
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API