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Ibuprofen

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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
September 6, 2019
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
September 6, 2019
Manufacturer
Bionpharma Inc.
Registration number
ANDA078682
NDC root
69452-239
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that is commonly used to relieve pain. It comes in the form of 200 mg capsules and is effective for treating various types of pain, including migraines. By reducing inflammation and blocking pain signals in the body, ibuprofen can help provide relief from migraine symptoms.

If you're looking for a way to manage pain, ibuprofen may be a suitable option for you, especially for migraine relief. Always consult with a healthcare professional to ensure it's the right choice for your needs.

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) or nonteratogenic effects (which refers to other types of harmful effects that could occur). This makes it a safer option for those concerned about potential risks. Always consult with your healthcare provider to ensure it's the right choice 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, and it’s best to use the smallest effective dose that helps your symptoms. For adults, the typical dosage is to take 2 capsules with a glass of water. If your symptoms continue or get worse, 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 old, it’s essential to speak with a doctor before taking this medication. Always prioritize your health and safety by following these guidelines.

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, or if you are about to undergo heart surgery or have just had one. It's important to be aware of potential serious side effects. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop using the medication and consult your doctor immediately.

Additionally, if you experience symptoms that may indicate heart problems or a stroke—like chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs—seek medical attention right away. If your migraine pain does not improve or worsens after the first dose, or if you develop any new symptoms, please contact your healthcare provider.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication 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 it for longer than recommended. There is also an increased risk of heart attack and stroke with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods.

If you experience symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, weakness on one side of the body, or slurred speech, you should stop using ibuprofen and consult a doctor immediately. It's also important to seek medical advice if you have a headache that feels different from your usual migraines, or if you have any new symptoms. Always talk to your doctor before using ibuprofen if you have a history of migraines, serious health conditions, or if you are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Signs of an allergic reaction include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you notice any of these symptoms, stop using the product and seek medical help immediately.

This medication may 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 can increase your risk of heart attack and stroke, especially if taken in higher doses or for extended periods. If you experience symptoms like faintness, vomiting blood, black stools, chest pain, or trouble breathing, stop using ibuprofen and contact your doctor right away.

If you suspect an overdose, seek emergency medical assistance or contact a Poison Control Center immediately. It's also important to be aware that using ibuprofen for more than 10 days a month may worsen headaches. Always consult your doctor if you have new symptoms or if your migraine pain does not improve after the first dose.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local poison control center for guidance. If you experience severe symptoms, such as trouble breathing or loss of consciousness, call emergency services immediately. Always prioritize your safety and well-being.

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. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being 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 increases if you take more than the recommended dose or use the medication for longer than advised. Additionally, older adults may be more sensitive to side effects and could have reduced kidney function, which means special precautions should be taken when using certain medications.

To ensure your safety, always follow the dosage instructions provided by your healthcare provider and discuss any concerns you may have about your medications. Being proactive about your health can help you avoid complications and maintain your well-being.

Renal Impairment

If you have kidney issues, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

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 be aware that certain medications can interact with ibuprofen, which may affect how well they work or increase the risk of side effects. For instance, if you take aspirin for heart attack or stroke, using ibuprofen at the same time may reduce the benefits of aspirin. Additionally, ibuprofen can interact with blood thinners (medications that prevent blood clots) and steroids, potentially leading to complications.

You should also be cautious if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as this can increase the risk of stomach bleeding. If you find yourself using ibuprofen frequently, especially for headaches, it could actually make your headaches worse if used for more than 10 days a month. Always consult your healthcare provider about any other medications you are taking while using ibuprofen to ensure your safety and well-being.

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 your product remains safe and effective for 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 used for?

Ibuprofen is a pain reliever (NSAID) that treats migraine and provides migraine relief.

What is the recommended dosage for adults?

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

Can I take Ibuprofen if I am under 18?

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

What should I do if I experience stomach bleeding?

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

Are there any warnings associated with Ibuprofen?

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

Is it safe to use Ibuprofen during pregnancy?

Consult a health professional before use if pregnant, especially during the last 3 months of pregnancy, as it may cause problems for the unborn child.

What should I do if my migraine pain is not relieved?

If your migraine headache pain is not relieved or worsens after the first dose, stop using Ibuprofen and consult a doctor.

How should I store Ibuprofen?

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

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Be Health is a nonsteroidal anti-inflammatory drug (NSAID) classified as a pain reliever, containing the active ingredient ibuprofen. Each capsule delivers a dosage of 200 mg of ibuprofen. The formulation consists of liquid-filled capsules designed for effective migraine relief. The product is packaged in a size of 120 softgels. The National Drug Code (NDC) for Be Health is 69452-239-22.

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 achieve the desired therapeutic effect.

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 of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications.

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as 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, the product should be discontinued and a doctor consulted.

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 ibuprofen, an 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 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.

Additionally, NSAIDs, excluding 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 prolonged periods.

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

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, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If migraine headache pain is not alleviated or worsens following the initial dose, or if any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients using ibuprofen should be aware of several serious adverse reactions associated with its use. Notably, ibuprofen may cause 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.

Additionally, the use of ibuprofen carries a risk of severe stomach bleeding, which 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. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

The risk of cardiovascular events, including heart attack, heart failure, and stroke, is also increased with the use of NSAIDs like ibuprofen, particularly when used in higher doses or for extended periods. Patients should seek immediate medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Furthermore, patients may experience medication overuse headaches if ibuprofen is used for 10 or more days per month. It is advised that patients discontinue use and consult a healthcare professional if migraine headache pain is not alleviated or worsens after the initial dose, or if any new symptoms arise.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider 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 that began after a 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 that may increase the risk of stomach bleeding, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also seek medical advice prior to use.

Drug Interactions

Co-administration of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction is significant and warrants consideration in patients requiring both medications.

Ibuprofen has the potential to interact with anticoagulants and corticosteroids, which may increase the risk of adverse effects, particularly gastrointestinal bleeding. Therefore, careful monitoring is advised when these medications are prescribed concurrently.

The concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, elevates the risk of gastrointestinal bleeding. It is recommended that patients avoid using multiple NSAIDs simultaneously.

Long-term use of ibuprofen, specifically for 10 or more days per month, may exacerbate headache conditions. Patients experiencing frequent headaches should consult a healthcare professional for alternative management strategies.

Patients are strongly advised to seek medical consultation if they are taking any other medications while using ibuprofen to ensure safe and effective treatment.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional before use. It is essential to evaluate 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. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of heart attack and stroke is elevated in geriatric patients who exceed the recommended dosage or duration of treatment. It is crucial for healthcare providers to monitor these patients closely to mitigate potential cardiovascular risks.

Special precautions should be implemented for elderly patients due to their increased sensitivity to side effects and the potential for reduced kidney function. Dose adjustments may be necessary to ensure safety and efficacy in this population. Regular assessment of renal function and vigilant monitoring for adverse effects are recommended to optimize treatment outcomes in geriatric patients.

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 crucial 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. The potential adverse effects on fetal outcomes necessitate careful consideration and professional guidance in managing pain or inflammation in pregnant individuals.

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 during the last three months of pregnancy unless specifically directed by a doctor, 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, caution is recommended when considering the use of this medication in lactating individuals.

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 individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis, angioedema, and urticaria. Gastrointestinal complications have been noted, including bleeding, ulceration, and perforation, which may occur unexpectedly at any time during treatment. Renal toxicity has also been reported, encompassing acute kidney injury and interstitial nephritis. Additionally, cardiovascular events, including heart attack and stroke, have been documented. Hepatic reactions, such as liver failure and hepatitis, have been observed. Furthermore, serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

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 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ibuprofen, 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, 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.