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Migraine Relief

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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 2019
Label revision date
August 24, 2021
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 2019
Label revision date
August 24, 2021
Manufacturer
Bionpharma Inc.
Registration number
ANDA078682
NDC root
69452-263
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen capsules are a type of pain reliever that contain 200 mg of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID). This medication is commonly used to help alleviate pain, including migraines. It works by reducing inflammation and blocking pain signals in the body, providing relief when you need it most.

These capsules are similar to the active ingredient found in Advil® Migraine, making them a reliable option for managing migraine symptoms. Each bottle contains 160 liquid-filled softgels, designed for easy swallowing and effective absorption.

Uses

If you suffer from migraines, this medication can help treat your symptoms effectively. It's important to note that this drug has not been associated with teratogenic effects, which means it does not cause birth defects if taken during pregnancy. Additionally, there are no reported nonteratogenic effects, indicating that it is generally safe in other respects as well. 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. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults, the recommended dosage is to take 2 capsules with a glass of water. If your symptoms continue or worsen, you should 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 of age, it's essential to speak with a doctor before taking this medication. Always prioritize your health by following these guidelines closely.

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, do not take it right before or after heart surgery, as this could pose serious risks to your health. Always consult with your healthcare provider if you have any questions or concerns about your medications.

Side Effects

Using ibuprofen can lead to some serious side effects that you should be aware of. There is a risk of severe allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), and skin rashes. Additionally, ibuprofen can cause severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with ibuprofen use, especially if taken in higher doses or for longer than recommended.

If you experience symptoms like faintness, vomiting blood, or black stools, you should stop using ibuprofen and consult a doctor immediately. Other warning signs include chest pain, difficulty breathing, or weakness on one side of your body. It's important to seek medical advice if you have any new or worsening symptoms, especially if you have a history of migraines or other serious health conditions. Always talk to your doctor before using ibuprofen if you have any concerns or are taking other medications.

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 and seek medical help immediately.

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 it for longer than recommended. Additionally, using ibuprofen for more than 10 days a month may worsen headaches. Be aware that NSAIDs, including ibuprofen, can increase the risk of heart attack and stroke, especially if used in higher doses or for extended periods.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop using ibuprofen and contact your doctor. Seek immediate medical assistance if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. In case of an overdose, get medical help or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is crucial to ensure the safety of both you and your baby.

Particularly during the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so. Using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it can potentially cause issues for your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

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 when taking medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. To minimize this risk, it is recommended that you take the smallest effective dose of the medication. Additionally, be cautious not to take the product for longer than directed, as older adults may have increased risk factors that could lead to complications.

Always consult with your healthcare provider to ensure that your medication plan is safe and appropriate for your age and health status. Your well-being is the priority, and understanding these guidelines can help you manage your health more effectively.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you are using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen, to ensure they work well together and to keep you safe.

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, which means keeping it below 40°C (104°F). Additionally, protect the product from light to maintain its integrity.

When handling the product, always do so with care to prevent any damage. Following these storage and handling guidelines will help ensure that 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 during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is ibuprofen capsules used for?

Ibuprofen capsules are a 200 mg pain reliever (NSAID) that treats migraine.

What should I do if the tamper-evident seal is broken?

Do not use the product if the tamper-evident seal under the bottle cap is broken or missing.

What is the recommended dosage for adults?

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

Can children under 18 use ibuprofen capsules?

If you are under 18 years of age, you should ask a doctor before use.

What should I do if I experience stomach bleeding?

Stop use and ask a doctor if you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools.

Is it safe to use ibuprofen during pregnancy?

You should ask a health professional before use if pregnant or breastfeeding, especially during the last 3 months of pregnancy.

What are the allergy risks associated with ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin, with symptoms like hives and facial swelling.

What are the warnings related to heart attack and stroke?

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke, especially if used more than directed.

How should ibuprofen be stored?

Store ibuprofen capsules at 20° to 25°C (68° to 77°F) and protect from excessive heat and light.

What should I do if my migraine pain does not improve?

If migraine headache pain is not relieved or worsens after the first dose, stop use and ask a doctor.

Packaging Info

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

Packaging configurations for Migraine Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen capsules are formulated as liquid-filled softgels, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its analgesic properties. The product is available in a package containing 160 softgels, designed for effective pain relief.

Uses and Indications

This drug is indicated for the treatment of migraine. There are no teratogenic effects associated with its use, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, 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.

NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

Patients should be aware that the use of this product for 10 or more days per month may lead to medication overuse headaches, potentially exacerbating headache symptoms.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients are advised to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical consultation is warranted. Patients should also seek medical advice if migraine headache pain is not alleviated or worsens after the initial dose, or if any new symptoms develop.

Side Effects

Patients using ibuprofen should be aware of several potential adverse reactions, which can vary in seriousness and frequency.

Severe allergic reactions may occur, 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), 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 problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Patients should 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.

It is advisable for patients to consult a healthcare provider before using ibuprofen if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, or have fever and stiff neck. Other considerations include headaches following head injury, exertion, coughing, or bending, daily headaches, or migraines severe enough to require bed rest. Patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke should also seek medical guidance prior to use.

Patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke should be particularly cautious, as ibuprofen may diminish the cardioprotective effects of aspirin. It is also recommended that patients consult a healthcare professional if they are taking any other medications.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when aspirin is used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the concurrent use of these medications to ensure optimal therapeutic outcomes. Monitoring for any potential reduction in the efficacy of aspirin is recommended when ibuprofen is administered.

Packaging & NDC

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

Packaging configurations for Migraine Relief.
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, are at an increased risk for severe stomach bleeding when using this product. Therefore, it is crucial for healthcare providers to exercise caution when prescribing to this population.

To mitigate risks, it is recommended that geriatric patients be administered the smallest effective dose necessary to achieve therapeutic outcomes. Additionally, the duration of use should be limited to the shortest time possible, as prolonged use may elevate the risk of adverse effects in elderly individuals.

Healthcare providers should closely monitor elderly patients for any signs of gastrointestinal complications and adjust treatment plans accordingly to ensure safety and efficacy.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester 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 weigh the benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to contact a poison control center or a medical toxicologist for guidance on the appropriate management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, especially among individuals over 60 years of age or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, medication overuse headache has been reported, which may exacerbate if the product is used for 10 or more days per month.

Patient Counseling

Patients should be advised to seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this medication should not be used if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be made aware of the symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, and should be advised to stop use and seek medical attention if these occur.

If a patient’s migraine headache pain is not relieved or worsens after the first dose, they should be instructed to stop use and consult a doctor. Furthermore, patients should be encouraged to report any new symptoms that arise during treatment.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for healthcare providers to recommend that patients consult a doctor before use if they have never had migraines diagnosed by a health professional, if they have a headache that differs from their usual migraines, or if they experience the worst headache of their life. Patients should also be advised to seek medical advice if they have fever and a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experience their first headache after the age of 50.

Patients with daily headaches or those with migraines severe enough to require bed rest should also be encouraged to consult a doctor before use. Additionally, patients should be informed to seek medical advice if the stomach bleeding warning applies to them, if they have experienced serious side effects from pain relievers or fever reducers, or if they have a history of stomach problems such as heartburn.

Healthcare providers should recommend that patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke consult a doctor before use. Patients taking diuretics or any other medications should also be advised to seek guidance from a doctor or pharmacist prior to use. Lastly, it is important to inform patients that if they are taking aspirin for heart attack or stroke, they should consult a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin.

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 exceeding 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 during the last trimester 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 Migraine Relief, 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 Migraine Relief, 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.