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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
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
August 25, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
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 2024
Label revision date
August 25, 2025
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
ANDA075010
NDC root
83324-056
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen is a medication that comes in 200 mg tablets and is commonly used as a pain reliever and fever reducer. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can take ibuprofen to temporarily relieve minor aches and pains caused by various conditions, including menstrual cramps, toothaches, headaches, backaches, muscular aches, and minor arthritis pain. Additionally, it helps to reduce fever.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. If you're looking for a way to manage discomfort or reduce a fever, ibuprofen may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including menstrual cramps, toothaches, the common cold, backaches, headaches, muscular aches, and minor arthritis pain. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to feel better and get back to your daily activities.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 1 caplet every 4 to 6 hours as needed while you have symptoms. If you find that 1 caplet isn't enough to relieve your pain or fever, you can take 2 caplets. However, make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

If you are giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to use the smallest effective dose to manage your symptoms and never take more than directed.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after undergoing heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. Additionally, this medication carries a risk of severe stomach bleeding, especially if you take it for longer than recommended, are over 60 years old, or consume alcohol regularly. It’s important to be aware that using ibuprofen can also increase the risk of heart attack and stroke, which can be life-threatening.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or slurred speech. Always talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, or other serious health conditions. Avoid using ibuprofen if you have had an allergic reaction to pain relievers or if you are scheduled for heart surgery.

Warnings and Precautions

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

Ibuprofen can also lead to severe stomach bleeding, particularly if you take it for longer than recommended, are over 60 years old, or have a history of stomach ulcers or bleeding problems. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods. It's important to consult your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or are taking other medications.

If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop taking ibuprofen and call your doctor right away. Seek emergency medical help if you have symptoms of a heart problem or stroke, such as chest pain, trouble breathing, or weakness on one side of your body. Also, contact your doctor if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days.

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.

Always err on the side of caution—if you notice any concerning changes in your health after taking a medication, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using 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 prioritize your health and the health of your baby by seeking guidance from your doctor.

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 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 12 years old, it's important to consult with a doctor before giving them this medication. For children aged 12 and older, you can administer 1 caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give 2 caplets. However, be sure not to exceed 6 caplets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to your child's health.

Geriatric Use

If you are an older adult or caring for one, it's important to be aware of certain risks when using this medication. It contains a type of pain reliever known as an NSAID, which can increase the risk of severe stomach bleeding, especially for those aged 60 and older.

Before using this product, you should consult with a doctor if you have any of the following conditions: high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, asthma, or if you have previously had a stroke. Taking these precautions can help ensure safer use of the medication.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition closely to ensure your safety.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware that certain medications can interact with each other, which may affect how well they work or increase the risk of side effects. For example, if you take ibuprofen, it might reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, combining ibuprofen with blood thinners or steroids can raise the risk of stomach bleeding.

Before starting any new medication, including over-the-counter drugs like ibuprofen, you should talk to your healthcare provider, especially if you are taking other medications, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke. This conversation is crucial to ensure your safety and the effectiveness of your treatment.

Storage and Handling

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

Always check the end flap of the packaging for the expiration date and lot number, which are essential for tracking the product's safety and quality. By following these simple storage and handling guidelines, you can help maintain the integrity of the product.

Additional Information

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. 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.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.

FAQ

What is Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis.

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

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better, stop taking Ibuprofen and call your doctor immediately.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 caplet every 4 to 6 hours while symptoms persist. Do not exceed 6 caplets in 24 hours unless directed by a doctor.

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. Consult a doctor if you have a history of stomach problems or are taking other medications.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use Ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to Ibuprofen?

If you experience symptoms such as skin reddening, rash, or difficulty breathing, stop using Ibuprofen and seek medical help immediately.

What is the recommended storage for Ibuprofen?

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

Who should not take Ibuprofen?

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

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)

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 and children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a maximum of 2 caplets may be administered. However, the total daily dosage must not exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

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 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. 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. The likelihood of this adverse effect increases under certain conditions, including but not limited to: prolonged use beyond the recommended duration, concurrent use with anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (either prescription or over-the-counter), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly heightened when ibuprofen is used in excess of the recommended dosage or for an extended period.

General Precautions Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have a history of gastrointestinal issues, such as heartburn, or if they are currently taking diuretics. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice. Those who have experienced stomach bleeding or serious side effects from pain relievers or fever reducers should also consult a healthcare provider. Furthermore, patients under medical supervision for serious conditions or those taking aspirin for cardiovascular protection should be cautioned, as ibuprofen may diminish the cardioprotective effects of aspirin.

Emergency Medical Help In cases of overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Signs to Monitor Patients should be instructed to discontinue ibuprofen and contact their healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, leg swelling, slurred speech, or weakness on one side of the body, warrant immediate medical evaluation. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

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

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 take higher doses or use the medication for extended periods, those who are 60 years of age or older, individuals taking anticoagulants or steroid medications, and patients with a history of stomach ulcers or bleeding problems. Additionally, consuming three or more alcoholic drinks daily while using ibuprofen may further increase this risk.

Patients should also be informed of the 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 excess of the recommended dosage or duration.

Patients are advised to discontinue use and consult a healthcare professional 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, leg swelling, slurred speech, or weakness on one side of the body, warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, patients should seek medical advice. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Before using ibuprofen, patients with a history of stomach issues, such as heartburn, or those taking diuretics, should consult a healthcare professional. Individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use.

It is crucial for patients to avoid ibuprofen if they have previously experienced an allergic reaction to any pain reliever or fever reducer, and it should not be used immediately before or after heart surgery.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen and aspirin is not recommended for individuals relying on aspirin for these indications.

The concomitant use of anticoagulants or steroid medications with ibuprofen may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Patients taking diuretics should consult a healthcare professional prior to using ibuprofen, as there may be potential interactions that require careful management.

Individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before initiating ibuprofen therapy to ensure safety and appropriate monitoring.

Additionally, patients are encouraged to discuss the use of ibuprofen with their healthcare provider if they are taking any other medications, as interactions may occur that necessitate adjustments in therapy.

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 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Due to this heightened risk, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, healthcare providers should inquire about the presence of any comorbid conditions in elderly patients, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These factors may necessitate careful monitoring and potential dose adjustments to ensure the safety and efficacy of the treatment in this population.

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 pregnancy 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 evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 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 the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 therapies may be employed as indicated.

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 non-teratogenic effects have been explicitly stated in the available data. Additionally, there are no specific findings related to animal pharmacology and toxicology provided in the extracted information.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of stomach problems, such as heartburn, or if they are currently taking a diuretic. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Healthcare providers should also inform patients to seek medical advice before using this medication if they have a warning regarding stomach bleeding. Patients with a history of problems or serious side effects from pain relievers or fever reducers should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be instructed to speak with their doctor or pharmacist if they are under medical care for any serious condition. It is crucial for patients taking aspirin for heart attack or stroke to consult their healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. Lastly, patients should be reminded to discuss any other medications they are taking with their healthcare provider or pharmacist before starting this medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

For proper inventory management, users are advised to refer to the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

Additional Clinical Information

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

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly crucial 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. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

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.