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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 1988
Label revision date
July 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1988
Label revision date
July 18, 2025
Manufacturer
Chain Drug Consortium
Registration number
ANDA075010
NDC root
68016-634
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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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, muscular aches, and minor arthritis pain. Additionally, ibuprofen helps to reduce fever, making it a versatile option for managing discomfort and illness.

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. If you're experiencing any of these symptoms, this medication may be a suitable option for you.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should never take more than what is directed, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dose is 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 have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and seek professional guidance when it comes to dosing for younger patients.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after undergoing 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 allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), skin reddening, shock, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, those with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

Moreover, using ibuprofen may elevate the chances of heart attack, heart failure, and stroke, particularly if taken in higher doses or for extended periods. If you experience symptoms like faintness, vomiting blood, bloody or black stools, chest pain, weakness on one side of the body, or trouble breathing, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have a history of stomach issues, 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, skin reddening, shock, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you 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 bloody or black stools, stop using ibuprofen and contact your doctor. Seek immediate 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 3 days, or if you notice any new symptoms or swelling in the painful area. In case of overdose, get 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 what you typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you’re unsure.

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 your baby's well-being by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and follow these guidelines to ensure your child's 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 or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking to help minimize potential risks. Your health and safety are paramount, so staying informed and proactive is key.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or have experienced a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe liver scarring), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition closely to ensure your safety.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan. Your well-being is a priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen. This way, you can ensure that your treatments work effectively and safely together.

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 with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

FAQ

What is Ibuprofen 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. You should stop use and seek medical help if you experience symptoms like fainting, vomiting blood, or chest pain.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use, especially not to use it at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I experience an allergic reaction to Ibuprofen?

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

What should I avoid while taking Ibuprofen?

Avoid taking Ibuprofen if you have had an allergic reaction to any other pain reliever or fever reducer, or if you are about to have heart surgery.

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

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 and is presented in a brown, round form. The product is packaged in a tamper-evident container, and it is essential to ensure that the safety seal under the cap is intact before use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 dose of 2 tablets may be administered. 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 other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to cardiovascular stability during this critical period.

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), skin reddening, shock, 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 carries a risk of severe stomach bleeding. The likelihood of experiencing such adverse effects 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.

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 an extended period.

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 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, 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.

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), 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 the medication in excess of the recommended guidelines.

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 gastrointestinal 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 advice prior to use. It is important for patients taking aspirin for heart attack or stroke prevention 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 serious conditions or those taking other medications should consult a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable for healthcare professionals to consider alternative analgesics that do not interfere with aspirin's efficacy in these clinical scenarios. Monitoring for cardiovascular outcomes may be warranted in patients who require both medications.

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. In cases where 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 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 ibuprofen in pregnant patients, especially in the later stages of pregnancy.

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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for 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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, serious cardiovascular events, such as myocardial infarction and stroke, have been documented.

Severe allergic reactions, including anaphylaxis and angioedema, have also been reported. Skin reactions, notably Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed in some cases. Furthermore, postmarketing surveillance has indicated an increased risk of gastrointestinal complications in patients with a history of gastrointestinal disease.

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 instructed to discontinue use and consult a doctor if they notice 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. Additionally, they should stop use and seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, weakness on one side of the body, leg swelling, slurred speech, or difficulty breathing.

Patients should be informed that if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days, they should consult a doctor. They should also report any new symptoms or the presence of redness or swelling in the painful area.

It is important for patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients should also be advised to seek medical advice if they have experienced 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 encouraged to consult a doctor before use if they are taking a diuretic or if they are under a doctor's care for any serious condition. They should also check with a 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 reminded to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, defined as temperatures exceeding 40°C (104°F). Additionally, it is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The 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 explicitly 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.