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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 2001
Label revision date
June 16, 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 2001
Label revision date
June 16, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA072096
NDC root
59779-647
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (8 NDCs)
Packaging & NDC Codes (8)

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Drug Overview

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that comes in tablet form, typically at a strength of 200 mg. It is commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever and alleviate discomfort associated with the common cold.

By working to decrease inflammation and pain signals in the body, ibuprofen provides effective relief for various everyday ailments. If you're looking for a way to manage mild pain or fever, ibuprofen may be a suitable option for you.

Uses

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

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with just 1 caplet, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using it right before or after heart surgery, as this can pose serious risks to your health.

This medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be aware that using it improperly can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using this medication in ways not prescribed.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

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 weakness on one side of the body. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or if you 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 other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal.

You should seek medical attention if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Also, contact your doctor if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or swelling in your legs. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, stop using ibuprofen and consult your doctor. In case of an overdose, get emergency help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. 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 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 you have a child under 12 years old, it's important to consult a doctor before giving them this medication. For adults and children aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet isn't effective for pain or fever, you may take two, but be sure not to exceed six caplets in a 24-hour period unless directed by a doctor.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 have a higher chance of experiencing severe stomach bleeding when taking nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. This risk is particularly concerning if you take these medications for longer than recommended or in higher doses than directed.

Additionally, using NSAIDs (except for aspirin) can increase your risk of heart attack, heart failure, and stroke. It's crucial to follow your healthcare provider's instructions carefully regarding dosage and duration of use to minimize these risks. Always discuss any concerns or questions with your doctor, especially if you are considering using NSAIDs for pain management.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke can complicate your situation. Your healthcare provider may need to adjust your medication dosages or monitor your kidney function more closely to ensure your safety and effectiveness of treatment.

Always communicate openly with your doctor about your kidney health and any other medical conditions you have. This will help them provide the best care tailored to your needs.

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 of how ibuprofen can interact with other medications and health conditions. For instance, if you're taking aspirin for heart health, using ibuprofen might reduce the benefits of aspirin. Additionally, if you have allergies, especially to aspirin, ibuprofen could trigger a severe allergic reaction. You should also be cautious if you're on blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen, as these can increase the risk of complications.

If you're over 60, the risk of stomach bleeding is higher when using ibuprofen. It's crucial to talk to your healthcare provider if you have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke before taking ibuprofen. Always discuss any medications or tests with your doctor 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 20-25°C (68-77°F). It's important to keep it away from high humidity and to avoid exposing it to excessive heat, which can occur at temperatures above 40°C (104°F).

When handling the product, make sure to maintain a clean environment to prevent contamination. Following these guidelines will help ensure the safety and effectiveness of your device.

Additional Information

You should take 1 caplet every 4 to 6 hours while your symptoms persist. If your pain or fever does not improve with 1 caplet, you may take 2 caplets. However, do not exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Avoid using ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may harm the unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and older?

You should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may take 2 caplets, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

What should I do if I experience signs of 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 improve.

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 certain health conditions or are taking other medications.

Can I use ibuprofen if I am pregnant or breastfeeding?

You should ask a health professional before using ibuprofen if you are pregnant or breastfeeding, especially after 20 weeks of pregnancy, as it may cause complications.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

What are the storage instructions for ibuprofen?

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

What should I do if I have a history of allergic reactions to pain relievers?

Do not use ibuprofen if you have ever had an allergic reaction to it or any other pain reliever/fever reducer. Consult a doctor for alternatives.

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

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen. The product is presented in the form of capsule-shaped tablets, with a total of 500 coated caplets per container. This formulation is comparable to the active ingredient found in Advil.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

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

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of 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 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.

Furthermore, NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for extended periods.

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 (1-800-222-1222).

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may 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 significant 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 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 particularly pronounced in patients who use ibuprofen in higher doses or for extended periods.

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, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if pain persists beyond 10 days, fever worsens or lasts more than three days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare provider if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical guidance prior to use. It is important for patients taking aspirin for heart attack or stroke to discuss their use of ibuprofen with a healthcare professional, as it may diminish the cardioprotective effects of aspirin. Additionally, patients under a doctor's care for any serious condition or those taking other medications should consult a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

The concomitant use of ibuprofen with certain medications may lead to significant interactions that warrant careful consideration.

Pharmacodynamic Interactions:

  • Aspirin: The co-administration of ibuprofen with aspirin, particularly in the context of cardiovascular protection (e.g., for heart attack or stroke), may diminish the antiplatelet effect of aspirin. It is advisable to separate the dosing of these medications to optimize therapeutic outcomes.

  • Anticoagulants and Steroids: Caution is advised when ibuprofen is used alongside anticoagulants or steroid medications due to the potential for increased bleeding risk. Monitoring for signs of bleeding is recommended.

  • Other NSAIDs: The use of ibuprofen in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen, should be approached with caution to avoid additive adverse effects.

  • Diuretics: Caution is also warranted when ibuprofen is taken with diuretics, as this combination may lead to reduced efficacy of the diuretic and potential renal impairment.

Pharmacokinetic Interactions:

  • Age Considerations: The risk of gastrointestinal bleeding associated with ibuprofen is notably increased in individuals aged 60 years or older. This demographic should be monitored closely for any signs of gastrointestinal distress.

Clinical Considerations:

Individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a healthcare professional prior to initiating ibuprofen therapy. This ensures that any potential risks are adequately assessed and managed.

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 and adults 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, 2 caplets may be administered. It is critical not to exceed 6 caplets within a 24-hour period unless directed by a healthcare provider.

Additionally, this medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further heightened in elderly patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage adjustments and ongoing assessment of the patient's cardiovascular status is advised when prescribing NSAIDs to 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 after 20 weeks of gestation 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. 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 any risks when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to dosing may be necessary based on the degree of renal impairment to avoid potential adverse effects and to optimize therapeutic outcomes.

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 and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

During postmarketing use of ibuprofen, various adverse reactions have been 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 documented. Serious cardiovascular events, including heart attack and stroke, have also been reported. Furthermore, other serious side effects associated with the use of pain relievers or fever reducers have been noted.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with specific health conditions should be advised to consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Furthermore, patients taking a diuretic should also seek medical advice before using the medication.

It is important for patients to discuss with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in this context. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are under medical care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, 2 caplets may be used, but the total should not exceed 6 caplets in a 24-hour period unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

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.