Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

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 1988
Label revision date
August 18, 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 1988
Label revision date
August 18, 2025
Manufacturer
Walgreen Company
Registration number
ANDA075010
NDC root
0363-0291
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (10 NDCs)
Packaging & NDC Codes (10)

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 medication that belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is commonly used to temporarily relieve minor aches and pains, including headaches, backaches, toothaches, muscular aches, menstrual cramps, and minor arthritis pain. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort and illness.

You may recognize ibuprofen as the active ingredient in products like Advil® Tablets. It works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, backaches, toothaches, muscular aches, and menstrual cramps. It can also help with minor arthritis pain and discomfort associated with the common cold. Additionally, this medication is effective in temporarily reducing fever.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

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 tablet every 4 to 6 hours as needed while your symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets. However, make sure not to exceed 6 tablets 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 minimize any potential risks.

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 using this medication safely.

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.

If you experience symptoms like faintness, vomiting blood, or black stools, or if you have chest pain, slurred speech, or difficulty breathing, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have a history of stomach issues, heart disease, or are taking other medications, especially blood thinners or diuretics.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include skin reddening, wheezing, rash, facial swelling, shock, blisters, or hives. 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 take it for longer than recommended, use blood thinners or steroids, are over 60, have a history of stomach ulcers, or consume three or more alcoholic drinks daily. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should get emergency medical help if you suspect an overdose. Stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), or if your pain or fever worsens or lasts longer than expected. Always consult your doctor if new symptoms arise or if you see redness or swelling in the area of pain.

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 typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.

Pregnancy Use

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

Lactation Use

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

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets instead. However, be sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

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, you may have a higher chance of experiencing severe stomach bleeding. To help minimize this risk, it's recommended that you take the smallest effective dose of your medication and avoid exceeding the prescribed amount. Always follow your healthcare provider's instructions closely to ensure your safety and well-being.

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 (severe liver scarring), 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 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 share your complete list of medications and any health conditions you have to 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°-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 compromise its effectiveness. Always check the expiration date on the package and use the product before this date to ensure safety and reliability.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

FAQ

What is Ibuprofen?

Ibuprofen is a pain reliever and fever reducer that belongs to a class of drugs known as NSAIDs (nonsteroidal anti-inflammatory drugs).

What conditions does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains due to headache, backache, toothache, the common cold, muscular aches, menstrual cramps, and minor pain of arthritis.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist, not exceeding 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding?

Stop use and ask a doctor if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Is Ibuprofen safe to use during pregnancy?

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 are the allergy risks associated with Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms can include skin reddening, rash, and facial swelling.

What should I do if I overdose on Ibuprofen?

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

Can I take Ibuprofen if I have high blood pressure?

You should ask a doctor before use if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke.

What storage conditions are recommended for Ibuprofen?

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

Packaging Info

Below are the non-prescription pack sizes of 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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, toothache, the common cold, muscular aches, menstrual cramps, 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must not exceed 6 tablets 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 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

Patients should be informed of the potential for severe allergic reactions associated with ibuprofen, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may 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.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Healthcare professionals should also be aware that 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 elevated with excessive or prolonged use of the medication.

In cases of suspected overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation.

Further, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if any new symptoms arise, or if there is redness or swelling in the area of pain. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

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

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 significant 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 blood thinners 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 increases the likelihood of stomach bleeding.

Patients should also be informed of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess or for longer than recommended.

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, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or redness or swelling occurs in the painful area, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke to discuss their use of ibuprofen, as it may diminish the cardioprotective effects of aspirin.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is crucial for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

In this population, it is recommended to administer the smallest effective dose and to ensure that the directed dosage is not exceeded. Close monitoring for any signs of gastrointestinal bleeding is advised, given the heightened risk associated with advancing age.

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 could lead to complications during delivery. Healthcare providers should carefully consider the potential benefits and risks when prescribing this medication to pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when recommending this medication to 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

Nonclinical Toxicology

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

Postmarketing Experience

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

Patient Counseling

Patients should be advised 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.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if they are subject to a stomach bleeding warning. Additionally, patients should be advised to discuss their use of diuretics with their healthcare provider prior to starting this medication.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be encouraged to consult their doctor before use. It is important for patients to inform their healthcare provider if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Furthermore, patients under a doctor's care for any serious condition should be advised to speak with their doctor or pharmacist before using this medication. Those taking aspirin for heart attack or stroke should be informed that ibuprofen may reduce the effectiveness of aspirin and should consult their healthcare provider. Lastly, patients should be encouraged to discuss any other medications they are taking with their doctor or pharmacist prior to use.

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 should be taken to avoid exposure to excessive heat, defined as temperatures exceeding 40°C (104°F). Additionally, it is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 pose risks to the unborn child or lead to complications during delivery.

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

Last AI update:

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.