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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 13, 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 13, 2026
Manufacturer
L. N. K. International, Inc.
Registration number
ANDA075139
NDC root
50844-438
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

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

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, 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. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dosage is to take 1 tablet every 4 to 6 hours as needed while 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 considering this medication for a child under 12 years old, it's essential to consult with a doctor first to determine the appropriate dosage. Always prioritize safety and follow the guidance provided by healthcare professionals.

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 specific situation. 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, which is a type of nonsteroidal anti-inflammatory drug (NSAID), can increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly while using it.

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. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use it for longer than recommended. It’s important to talk to your doctor before using ibuprofen if any of these conditions apply to you.

Using ibuprofen also increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods. If you are taking aspirin for heart protection, consult your doctor, as ibuprofen may reduce its effectiveness. You should seek emergency medical help if you suspect an overdose. Stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or 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 reach out to your healthcare provider if new symptoms arise or if you notice redness or swelling in the painful area.

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 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 those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets instead. However, be sure not to exceed 6 tablets in a 24-hour period unless a 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 that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, you should be vigilant for any signs of stomach bleeding, such as unusual stomach pain or blood in your stool.

Additionally, healthcare providers may recommend adjusting the dosage of certain medications for older adults. This is because older individuals can be more sensitive to side effects. Always consult with your doctor about the best approach to medication management, ensuring that you receive the safest and most effective care.

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 health 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 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 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 maintain a clean environment to prevent contamination. 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 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 tablet every 4 to 6 hours while symptoms persist, not exceeding 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have a history of stomach problems or are taking other medications.

Can 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 taking ibuprofen and call your doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

What precautions should elderly patients take when using ibuprofen?

Elderly patients should monitor for signs of stomach bleeding and may need dosage adjustments due to increased sensitivity to side effects.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double up.

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.

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 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 daily 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 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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include 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.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients taking anticoagulants or steroid medications, those using other NSAIDs (including aspirin, ibuprofen, or naproxen), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is 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 excess of the recommended dosage or for extended periods.

General Precautions Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, a history of gastrointestinal issues such as heartburn, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before use.

Patients should also be cautioned to consult a doctor or pharmacist if they are currently taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Furthermore, individuals under medical supervision for serious health conditions or those taking other medications should seek guidance before using ibuprofen.

Emergency Medical Help In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

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

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in 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), skin reddening, shock, 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 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 ibuprofen in excess of the recommended dosage or for prolonged 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, leg swelling, slurred speech, or difficulty breathing, also warrant immediate medical attention. Furthermore, patients should seek medical advice if their pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is redness or swelling in the affected area.

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

Drug Interactions

There are currently no documented drug interactions associated with 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. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding.

In addition to vigilant monitoring, dosage adjustments may be necessary for geriatric patients due to their heightened sensitivity to side effects. Careful consideration of these factors is crucial in ensuring the safety and efficacy of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of this medication 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 a history of liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks associated with their liver function. Monitoring of liver function may be necessary to ensure safety and efficacy during treatment. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the individual patient's condition to determine the most suitable approach.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the management of an overdose may vary depending on the specific substance involved and the severity of the symptoms presented. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Potential symptoms of overdose can include a range of physiological and psychological effects, which may necessitate supportive care and monitoring. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

In summary, immediate medical attention is critical in cases of overdose, and healthcare professionals should be equipped to provide comprehensive care and support to affected individuals.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

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, or 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, weakness in one part or side of the body, leg swelling, slurred speech, and difficulty breathing.

Furthermore, there have been instances of pain worsening or persisting for more than 10 days, as well as 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 healthcare provider before using this medication if they have a history of stomach bleeding or if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, those with a history of stomach issues, such as heartburn, should also seek medical advice prior to use.

It is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously suffered a stroke. Patients taking diuretics should also consult their healthcare provider before using this medication.

Furthermore, patients should be informed that if they are taking aspirin for the prevention of heart attack or stroke, they should speak with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should also seek guidance from their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, defined as temperatures exceeding 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 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.

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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.