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Advil Migraine

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2000
Label revision date
October 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2000
Label revision date
October 3, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
NDA020402
NDC root
0573-0168
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Advil is a medication that contains solubilized ibuprofen, a type of non-steroidal anti-inflammatory drug (NSAID). It is commonly used to relieve pain, including headaches and migraines. The liquid-filled capsules are designed to provide effective relief from discomfort, helping you feel better when you need it most. Each capsule contains 200 mg of ibuprofen, making it a convenient option for managing pain.

Uses

If you suffer from migraines, this medication can help treat your condition. Migraines are intense headaches that can be accompanied by other symptoms like nausea and sensitivity to light. This treatment is specifically designed to alleviate the pain and discomfort associated with these episodes.

It's important to note that this medication does not have any known teratogenic effects, meaning it is not expected to cause birth defects if taken during pregnancy. Always consult with your healthcare provider for personalized advice and to ensure this treatment is right for you.

Dosage and Administration

When taking this medication, it’s important to follow the instructions carefully. You should not take more than the recommended amount. For adults, the typical dose is to take 2 capsules with a glass of water. If your symptoms continue or get worse, it’s best to consult your doctor. Remember, you should not exceed 2 capsules in a 24-hour period unless your doctor advises otherwise.

If you are under 18 years old, you should check with a doctor before taking this medication. Always use the smallest effective dose to manage your symptoms safely. Make sure to take the capsules orally, which means swallowing them with water. Following these guidelines will help ensure you use the medication safely and effectively.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after heart surgery, as it may pose risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, those with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

If you experience symptoms like feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor. Be cautious if you have heart problems or experience chest pain, trouble breathing, weakness on one side of the body, slurred speech, or leg swelling. It's important to seek medical advice if you have any new symptoms or if your migraine pain worsens after taking the medication. Always consult a healthcare professional if you have a history of allergies to pain relievers, stomach issues, or other serious health conditions before using ibuprofen.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this medication. First, if you have a known allergy to aspirin or other pain relievers, do not use this product, as it may cause a severe allergic reaction. Symptoms can include hives, facial swelling, wheezing, and even shock. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also increase the risk of serious stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs (nonsteroidal anti-inflammatory drugs). Additionally, using this product for more than directed can raise your risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop taking the medication and call your doctor right away. You should also seek medical attention if you experience chest pain, trouble breathing, or weakness on one side of your body, as these may indicate heart problems or a stroke.

If you suspect an overdose, get medical help or contact a Poison Control Center immediately. Remember, if your migraine pain does not improve after the first dose or if you develop any new symptoms, it’s important to stop using the medication and consult your doctor.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait to see if symptoms improve; prompt action is essential for your safety. Always keep emergency contact information handy, and remember that getting help quickly can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 18 years old, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional guidance.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk means that you should discuss any medications you are taking with your healthcare provider, especially if you have a history of stomach issues or are on other medications that may increase this risk.

Always make sure to follow your doctor's advice regarding dosages and any necessary precautions. Your healthcare provider can help you understand how to manage your medications safely to minimize potential side effects.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke can complicate your situation. It's essential to monitor your kidney function regularly, especially if you are taking medications that may impact your kidneys.

Make sure to discuss any necessary dosage adjustments with your healthcare provider, as they may need to tailor your treatment based on your kidney function. Keeping an open line of communication with your doctor will help ensure that you receive the safest and most effective care.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This ensures that the medication is safe and effective for you.

Always communicate openly with your doctor about your liver condition and any other health issues you may have, such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. This information is crucial for managing your overall health and ensuring the best possible care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from excessive heat, so avoid temperatures above 40°C (104°F).

When handling the product, check the seal under the bottle cap. If the seal is broken or missing, do not use the product, as this could compromise its safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is Advil?

Advil is a pain reliever that contains solubilized ibuprofen capsules, 200 mg.

What does Advil treat?

Advil is indicated for the treatment of migraine.

How should I take Advil?

Adults should take 2 capsules with a glass of water, and do not exceed 2 capsules in 24 hours unless directed by a doctor.

What should I do if I am under 18 years old?

If you are under 18 years of age, ask a doctor before using Advil.

Are there any contraindications for using Advil?

Do not use Advil if you have had an allergic reaction to any other pain reliever or if you are using it right before or after heart surgery.

What are the potential side effects of Advil?

Advil may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke.

What should I do if I experience signs of stomach bleeding?

Stop using Advil and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Can I use Advil if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially if you are 20 weeks or later in pregnancy.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

How should I store Advil?

Store Advil at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

Packaging Info

Below are the non-prescription pack sizes of Advil Migraine (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Advil Migraine.
Details

Drug Information (PDF)

This file contains official product information for Advil Migraine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of migraine.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults are advised to take 2 capsules orally with a glass of water. It is essential to use the smallest effective dose and not to exceed 2 capsules within a 24-hour period unless directed by a healthcare professional. If symptoms persist or worsen, patients should consult their doctor for further guidance.

For individuals under 18 years of age, it is recommended to seek advice from a healthcare professional before administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended guidelines.

Medication Overuse Headache Warning Patients may experience exacerbation of headaches if ibuprofen is utilized for 10 or more days within a month.

General Precautions Ibuprofen should not be administered to individuals with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is contraindicated for use immediately before or after heart surgery.

Emergency Medical Help Instructions In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. Furthermore, if migraine headache pain is not alleviated or worsens after the initial dose, or if any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or use other NSAIDs concurrently.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Patients may also experience medication overuse headaches if ibuprofen is used for 10 or more days per month.

Patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, should also prompt immediate medical consultation. Furthermore, if migraine headache pain is not alleviated or worsens after the first dose, or if any new symptoms arise, patients should seek medical advice.

It is important to note that ibuprofen should not be used by individuals with a history of allergic reactions to any pain reliever or fever reducer, nor should it be taken immediately before or after heart surgery. Patients should consult a healthcare provider prior to use if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, present with fever and stiff neck, or have headaches following head injury, exertion, coughing, or bending. Additional caution is warranted for those with a history of daily headaches, severe migraines requiring bed rest, or any conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients taking diuretics or those under medical care for serious conditions should also seek advice before using ibuprofen. It is particularly important for patients taking aspirin for heart attack or stroke to consult a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Advil Migraine (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Advil Migraine.
Details

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional before use. It is essential to assess the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs and symptoms of gastrointestinal bleeding is advised in geriatric patients, especially when initiating treatment or adjusting dosages. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to mitigate potential adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against any risks when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease. Patients with reduced kidney function may experience altered drug clearance, necessitating modifications to the standard dosing regimen. Regular monitoring of renal function is advised to ensure safety and efficacy in this population. Additionally, healthcare professionals should remain vigilant for potential complications associated with concurrent conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these may further impact renal function and overall treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Patients with significant hepatic impairment should be approached with caution, and the potential benefits of treatment must be weighed against the risks associated with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions have also been documented, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Additionally, cases of liver enzyme elevations and liver failure have been reported. Anaphylactic reactions, which encompass instances of angioedema and bronchospasm, have been noted. Furthermore, there have been reports of medication overuse headache linked to prolonged use of ibuprofen.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additionally, it is imperative that the product is not used if the seal under the bottle cap, which is imprinted with “SEALED for YOUR PROTECTION,” is broken or missing. Proper handling and storage conditions are essential to maintain the integrity and safety of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Advil Migraine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Advil Migraine, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.