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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 1999
Label revision date
February 2, 2026
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 1999
Label revision date
February 2, 2026
Manufacturer
H E B
Registration number
ANDA075139
NDC root
37808-393
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Drug Overview

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

This medication works by blocking certain substances in the body that cause inflammation and pain, making it effective for managing various types of discomfort. If you're looking for a reliable option to alleviate pain or reduce fever, ibuprofen may be a suitable choice for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, toothaches, backaches, menstrual cramps, and even discomfort from the common cold. It can also help with minor arthritis pain.

In addition to alleviating pain, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

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 instead. 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 safely.

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, it is important not to use it right before or after 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.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include rash, blisters, hives, facial swelling, shock, asthma (wheezing), and skin reddening. Additionally, this medication can 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, especially if used in higher doses or for extended periods. If you experience symptoms such as chest pain, weakness on one side of the body, slurred speech, or trouble breathing, seek medical attention immediately. It's important to stop using ibuprofen and consult a doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Always talk to your doctor if you have existing health conditions or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include rash, blisters, hives, facial swelling, shock, asthma (wheezing), skin reddening, and more. 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.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems or stroke like chest pain or weakness on one side of your body, stop using ibuprofen and contact your doctor. Also, seek emergency medical help if you suspect an overdose. Remember to consult your doctor if your pain worsens or lasts more than 10 days, or if your fever persists for more than three 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.

Don’t wait for symptoms to worsen; acting quickly can be vital. Always keep emergency contact information handy, and remember that your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s essential 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 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 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 isn't enough to relieve pain or fever, you may give them 2 caplets, but 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 treating younger children.

Geriatric Use

If you are 60 years or older, it's important to be aware that this product contains a type of medication called an NSAID, which can increase the risk of severe stomach bleeding. This risk is particularly higher for older adults, so you should take extra precautions.

Before using this medication, consult with your 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. Your doctor can help determine if this medication is safe for you and may suggest alternative options if necessary.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

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 more closely. This is crucial to ensure your safety and the effectiveness of the treatment.

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.

Drug Interactions

It's important to be aware that taking ibuprofen alongside aspirin can reduce the effectiveness of aspirin in preventing blood clots. This may increase your risk of heart-related issues. Because of this potential interaction, it's crucial to discuss all medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatments.

Always consult with your doctor or pharmacist before starting any new medications, especially if you are already on aspirin or other treatments, to avoid any unintended effects.

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.

Additionally, please check the end flap of the packaging for the expiration date and lot number, which are important for tracking the product's safety and quality. Always handle the product with care to maintain its integrity and safety.

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?

Ibuprofen is a pain reliever and fever reducer available in 200 mg tablets. It 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 from headaches, muscular aches, toothaches, backaches, menstrual cramps, the common cold, and minor arthritis pain.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 caplet every 4 to 6 hours while symptoms persist, not exceeding 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 certain health conditions or experience severe side effects.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen, especially after 20 weeks of pregnancy, as it may cause complications.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

What should I avoid while taking Ibuprofen?

Avoid taking Ibuprofen if you have had an allergic reaction to pain relievers, or if you are about to undergo heart surgery. Also, limit alcohol consumption and consult a doctor if you have certain medical conditions.

How should I store 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, muscular aches, toothache, backache, menstrual cramps, the common cold, 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 is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include rash, blisters, hives, facial swelling, shock, asthma (wheezing), skin reddening, and other manifestations. 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, naproxen, or similar agents), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of treatment.

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.

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 should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, unilateral weakness, slurred speech, difficulty breathing, 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 there is redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

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 rash, blisters, hives, facial swelling, shock, asthma (wheezing), and skin reddening.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of gastrointestinal complications.

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, particularly when the medication is used 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 experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, weakness on one side of the body, slurred speech, difficulty breathing, or leg swelling, warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

It is recommended that patients consult a healthcare provider prior to using ibuprofen if they are taking diuretics, have a history of gastrointestinal issues, or if the warnings regarding stomach bleeding apply to them. Individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical guidance. Additionally, patients under a doctor's care for serious conditions or those taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the effectiveness of aspirin.

Drug Interactions

Ibuprofen has been observed to potentially diminish the antiplatelet effect of aspirin when administered concurrently. This interaction may lead to an increased risk of cardiovascular events. Therefore, it is advisable to monitor patients closely for any signs of cardiovascular complications when these medications are used together.

No additional drug interactions or laboratory test interactions have been reported.

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 while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in 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 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 assess the patient's medical history, particularly for conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is advisable for elderly patients to consult with their healthcare provider prior to use if they have any of these underlying health issues, as they may require careful monitoring or dosage adjustments to mitigate potential risks associated with NSAID therapy.

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 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 healthcare 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, caution is recommended when considering the use of this medication during lactation.

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 the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

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 be aware that they can vary based on the substance involved and the individual patient’s condition.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's clinical status and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are currently no additional adverse events or rare case reports available for review.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use this product right before or after heart surgery.

Healthcare providers should instruct patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, such as chest pain, weakness on one side of the body, slurred speech, difficulty breathing, or leg swelling.

Patients should be informed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. Healthcare providers should recommend that patients consult a doctor before use if they are taking a diuretic, have a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them.

Patients should also be encouraged to seek medical advice before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Furthermore, patients should be advised to consult a doctor or pharmacist before use if they are under a doctor's care for any serious condition, if they are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or if they are taking any other medications.

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 controlled room temperature between 20° and 25°C (68° and 77°F). Care should be taken to avoid exposure to excessive heat, with a maximum temperature limit of 40°C (104°F).

For proper inventory management, the expiration date and lot number are located on the end flap of the packaging. Special handling precautions should be observed to maintain the integrity of the product throughout its storage and usage.

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.

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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.