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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
January 12, 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
January 12, 2026
Manufacturer
L. N. K. International, Inc.
Registration number
ANDA075139
NDC root
50844-353
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200 mg tablet form. It is commonly used to temporarily relieve minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, ibuprofen helps to reduce fever, making it a versatile option for managing discomfort associated with various conditions, including the common cold.

Uses

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

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to note that there are no reported teratogenic effects (which means it doesn't 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 caplet every 4 to 6 hours as needed while your symptoms persist. 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 considering giving this medication to a child under 12 years old, it's best to consult with a doctor first. 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 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 questions or concerns about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Using ibuprofen can lead to some serious side effects that you should be aware of. It may cause severe allergic reactions, particularly if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, skin reddening, shock, rash, and blisters. Additionally, ibuprofen is an NSAID (nonsteroidal anti-inflammatory drug) that can increase the risk of stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal. This risk increases if you take more than the recommended dose or use it for an extended period. If you experience symptoms like faintness, vomiting blood, or chest pain, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have any underlying 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 hives, facial swelling, wheezing, skin reddening, shock, 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.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop using ibuprofen and contact your doctor. Seek medical attention if you experience chest pain, weakness on one side of your body, leg swelling, slurred speech, or trouble breathing. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than three days, or if you notice any new symptoms or swelling in the painful area. In case of an overdose, get emergency medical help or contact a Poison Control Center right away.

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 think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be vital for safety and recovery.

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 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 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.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets, but be sure not to exceed six caplets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you have a history of stomach ulcers or bleeding problems, or if you are taking medications like blood thinners or steroids, you should take special precautions.

Before starting any new medication, it's wise to consult your doctor, especially if you have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Older adults may also be more sensitive to side effects, so discussing your health history with your healthcare provider can help ensure your safety and well-being.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Inform them about any other health conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider 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.

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 affect your treatment plan. Your safety is the priority, so don’t hesitate to ask questions or express any concerns you may have.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 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 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 used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over 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 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, heart disease, or if you are taking other medications.

Can ibuprofen be taken 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 should I do if I experience signs of stomach bleeding?

Stop using ibuprofen and seek medical help if you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

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

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

How should ibuprofen be stored?

Store ibuprofen between 20°-25°C (68°-77°F) and avoid excessive heat above 40°C (104°F). Use by the expiration date on the package.

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 have 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)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, 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 may elicit 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), skin reddening, shock, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated 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 associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher doses or prolonged treatment.

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 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, unilateral weakness, leg swelling, slurred speech, or difficulty breathing, 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 any new symptoms arise, or if there is redness or swelling in the affected area. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients using ibuprofen should be aware of 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 hives, facial swelling, asthma (wheezing), skin reddening, shock, rash, and blisters.

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 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 while using the product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended guidelines.

Patients are advised to discontinue use and consult a healthcare professional if they experience 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, leg swelling, slurred speech, or difficulty breathing, also warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, or if any new symptoms arise, patients should seek medical advice. Redness or swelling in the painful area should also be evaluated by a healthcare provider.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to discuss use with a healthcare provider if the patient is taking diuretics or aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

In summary, while ibuprofen can be effective for pain relief, it is essential for patients to be aware of these potential adverse reactions and to seek medical guidance when necessary.

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 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 otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing medications that may exacerbate this condition.

In addition, geriatric patients may exhibit increased sensitivity to side effects, which underscores the importance of dose adjustments and vigilant observation for adverse reactions. Special precautions are warranted for elderly individuals with a history of stomach ulcers or bleeding disorders, as well as those concurrently using blood thinners or steroids.

Healthcare providers are advised to consult with elderly patients regarding the stomach bleeding warning, especially for those with comorbidities such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These considerations are critical to ensuring the safe and effective use of medications in this vulnerable 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 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 consider the potential risks and benefits when prescribing this medication to 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 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 liver cirrhosis. It is essential to evaluate liver function and consider potential risks associated with compromised liver health. Monitoring of liver function may be necessary to ensure safe use of the medication in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

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 adverse reactions.

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 a Poison Control Center 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

Postmarketing experience has indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms include hives, facial swelling, asthma (wheezing), skin reddening, shock, rash, and blisters.

Additionally, there have been reports of stomach bleeding associated with ibuprofen use, especially in patients aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, individuals taking blood thinners or steroids, those consuming three or more alcoholic drinks daily, and patients using other nonsteroidal anti-inflammatory drugs (NSAIDs).

Postmarketing data also suggest an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, particularly when ibuprofen is used at higher doses or for prolonged periods. Adverse reactions related to cardiovascular issues reported in the postmarketing experience include symptoms such as chest pain, unilateral weakness, leg swelling, slurred speech, and difficulty breathing.

Furthermore, there have been instances of pain worsening or persisting beyond 10 days and fever worsening or lasting more than 3 days in patients using ibuprofen.

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 doctor before using this medication if they have a history of stomach bleeding or if they have experienced problems or serious side effects from taking pain relievers or fever reducers. Additionally, patients with a history of stomach issues, such as heartburn, should also seek medical advice prior to use.

Healthcare providers should inquire about the patient's medical history, specifically regarding high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or previous strokes, as these conditions may necessitate caution. Patients taking diuretics should be advised to consult their doctor before using this medication.

It is important for patients to discuss their use of aspirin for heart attack or stroke with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in these situations. Furthermore, patients under a doctor's care for any serious condition should seek guidance before using this medication. Lastly, patients should be encouraged to inform their healthcare provider or pharmacist about any other medications they are currently taking to avoid potential interactions.

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 controlled room temperature, specifically between 20°-25°C (68°-77°F). Care should be taken to avoid exposure to excessive heat, with a maximum temperature limit of 40°C (104°F). Additionally, healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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

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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.