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Ibuprofen 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 2021
Label revision date
December 8, 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 2021
Label revision date
December 8, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA078682
NDC root
69842-892
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

CVSHealth® is a medication that contains ibuprofen (a type of pain reliever) in a 200 mg capsule form. It is classified as a nonsteroidal anti-inflammatory drug (NSAID), which means it works by reducing inflammation and alleviating pain.

This product is specifically indicated for the treatment of migraines, helping to relieve the discomfort associated with this type of headache. Each package contains 80 softgels, making it convenient for those who may need to manage migraine symptoms.

Uses

You can use this medication to help treat migraines, which are severe headaches often accompanied by other symptoms like nausea or sensitivity to light. It's important to note that this medication does not have any known effects that could harm a developing fetus (teratogenic effects) or cause other nonteratogenic effects. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and the effectiveness of the medication. For adults, you should take 2 capsules with a full glass of water. If your symptoms continue or get worse, it's best to consult your doctor. Remember, you should not take more than 2 capsules in a 24-hour period unless your doctor advises otherwise.

If you are under 18 years old, you should speak with a doctor before taking this medication. Always use the smallest effective dose to minimize any potential risks. Make sure to adhere to these guidelines for the best results.

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 it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your eligibility to use this medication. Your safety is the top priority.

Side Effects

You should be aware that ibuprofen can cause serious allergic reactions, particularly if you are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID), can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if you exceed the recommended dosage or duration of use. If you experience symptoms such as faintness, vomiting blood, black or bloody stools, persistent stomach pain, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, you should stop using ibuprofen and consult a doctor immediately. Additionally, if your migraine pain does not improve or worsens after the first dose, or if you notice any new symptoms, seek medical advice.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for more than 10 days a month may worsen headaches. Be aware that NSAIDs, excluding aspirin, can increase the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Seek medical attention if you have symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If your migraine pain does not improve or worsens after the first dose, or if you develop any new symptoms, consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

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 delivery issues for your baby or complications during labor. Always seek guidance from your doctor to ensure the safety of both you and your child.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to delivery 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 risks associated with medications, especially those containing nonsteroidal anti-inflammatory drugs (NSAIDs). These medications can increase the chance of severe stomach bleeding, particularly if you are 60 years or older. Additionally, using more than the recommended dose or taking the medication for longer than advised can raise your risk of heart attack and stroke.

To stay safe, it's best to take the smallest effective dose and stick to the recommended guidelines. Always consult with your healthcare provider to ensure that your medication plan is appropriate for your age and health status.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can damage the product. Additionally, keep it protected from light to maintain its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these storage and handling guidelines will help ensure the product remains safe and effective for your use.

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 lead to complications for both the unborn child and during delivery.

FAQ

What is CVSHealth® used for?

CVSHealth® is used to treat migraine headaches.

What is the active ingredient in CVSHealth®?

The active ingredient is Ibuprofen, which is a 200 mg pain reliever classified as a nonsteroidal anti-inflammatory drug (NSAID).

How should I take CVSHealth®?

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

Are there any warnings associated with CVSHealth®?

Yes, CVSHealth® may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke, especially if used improperly.

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

Stop using CVSHealth® and seek medical help if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Can I use CVSHealth® if I am pregnant or breastfeeding?

You should ask a health professional before using CVSHealth® if you are pregnant or breastfeeding, especially after 20 weeks of pregnancy.

What should I do if I have an allergic reaction to CVSHealth®?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

What is the packaging of CVSHealth®?

CVSHealth® is available in a package containing 80 softgels (liquid-filled capsules).

Who should not use CVSHealth®?

Do not use CVSHealth® if you have had an allergic reaction to any pain reliever/fever reducer or if you are about to undergo heart surgery.

Packaging Info

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

Packaging configurations for Ibuprofen Migraine.
Details

Drug Information (PDF)

This file contains official product information for Ibuprofen 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

Patients should adhere strictly to the prescribed dosage and not exceed the recommended amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults, the recommended dosage is 2 capsules taken with a full glass of water. If symptoms persist or worsen, patients are advised to consult their healthcare provider. It is important to note that no more than 2 capsules should be taken within a 24-hour period unless otherwise directed by a physician.

For individuals under 18 years of age, it is essential to seek guidance 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 may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using 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.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be aware of the potential for medication overuse headaches, which may occur if this product is utilized for 10 or more days within a month.

Patients should be advised to discontinue use and consult a physician if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. If migraine headache pain is not alleviated or worsens following the initial dose, or if any new symptoms arise, medical consultation is also recommended.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, the use of ibuprofen carries a risk of severe stomach bleeding, especially 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, or exceed the recommended dosage or duration of use.

The risk of cardiovascular events, including heart attack, heart failure, and stroke, is also heightened with the use of NSAIDs, including ibuprofen, particularly when used in higher doses or for extended periods. These events can be fatal.

Common adverse reactions may include headaches, which can worsen if ibuprofen is used for 10 or more days per month, leading to medication overuse headaches.

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, also 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.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Ibuprofen 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 may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 and older.

Additionally, the risk of heart attack and stroke is elevated in geriatric patients, particularly when the medication is used in excess of the recommended dosage or for prolonged periods. Therefore, it is crucial for healthcare providers to advise elderly patients to adhere strictly to the prescribed dosage and duration of therapy.

To minimize potential risks, it is recommended that the smallest effective dose be utilized in elderly patients, and careful monitoring should be conducted to ensure safety and efficacy throughout the treatment course.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician. The use of ibuprofen during this period may lead to delivery complications or adverse fetal outcomes. Women of childbearing potential should be aware of these risks and seek medical advice regarding the use of this medication during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. 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 lead to delivery complications for the unborn child. 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 risks and benefits when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 delivery problems in the unborn child or complications during delivery. No relevant information regarding non-teratogenic effects, carcinogenicity, mutagenicity, or impairment of fertility has been extracted. Additionally, there is no relevant data available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and cardiovascular events.

Gastrointestinal bleeding has been reported, particularly in patients with a history of gastrointestinal issues. Renal impairment has also been noted, especially among individuals with pre-existing kidney conditions or those experiencing dehydration. Additionally, cardiovascular events, including heart attack and stroke, have been documented, particularly in patients using ibuprofen at higher doses or for extended durations.

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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Ibuprofen 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 Ibuprofen 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.