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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
January 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet
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 2021
Label revision date
January 3, 2024
Manufacturer
Basic Drugs, Inc.
Registration number
ANDA079174
NDC root
0761-0908
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

If you are a consumer or patient please visit this version.

Drug Overview

Ibuprofen is a medication commonly used to temporarily relieve minor aches and pains, such as those caused by the common cold, headaches, toothaches, muscular aches, backaches, menstrual cramps, and minor arthritis pain. In addition to pain relief, ibuprofen also helps to temporarily reduce fever, making it a versatile option for managing discomfort and feverish symptoms.

Uses

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

This medication is designed to provide you with comfort when you're experiencing these common discomforts, allowing you to feel better and get back to your daily activities.

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 dose 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 instead. However, make sure not to exceed 6 tablets 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 essential to consult with a doctor first.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to ensure proper use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers, or who consume alcohol regularly. It can also increase the risk of heart attack and stroke, particularly if used in higher doses or for extended periods.

If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, you should stop using ibuprofen and consult a doctor. Be cautious if you have a history of heart problems, high blood pressure, or other serious conditions, and always talk to your doctor if you are taking other medications or have concerns about side effects.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If you experience symptoms like hives, facial swelling, wheezing, or skin blisters, stop using ibuprofen immediately and seek medical help. Additionally, this medication may lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and contact your doctor right away.

There are also risks of heart attack and stroke associated with ibuprofen, particularly if taken in higher doses or for extended periods. Before using ibuprofen, consult your doctor if you have any serious health conditions, such as high blood pressure, heart disease, or a history of stomach problems. If you are pregnant or breastfeeding, it's crucial to talk to a healthcare professional before using this medication, especially after 20 weeks of pregnancy, as it may pose risks to your baby. Always take ibuprofen with food or milk to help prevent stomach upset.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

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 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 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 of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding when using this product. Additionally, older adults may face an increased risk of side effects and complications, which means you should be especially cautious and consult with your healthcare provider about any medications you are considering.

Always discuss your full medical history and any other medications you are taking with your doctor to ensure your safety and well-being. Taking these precautions can help you manage your health more effectively as you age.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, including high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

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° and 25°C (68° and 77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

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 temporarily relieves minor aches and pains due to conditions like the common cold, headache, toothache, muscular aches, backache, menstrual cramps, and minor arthritis pain. It also temporarily reduces fever.

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

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using Ibuprofen and seek medical help immediately.

What are the warnings associated with taking Ibuprofen?

Ibuprofen may cause severe stomach bleeding, especially in older adults or those with certain medical conditions. It also increases the risk of heart attack and stroke.

How should I take Ibuprofen?

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.

Is Ibuprofen safe to use during pregnancy?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen. It is particularly important to avoid it after 20 weeks of pregnancy unless directed by a doctor.

What should I do if I have a history of stomach problems?

You should ask a doctor before using Ibuprofen if you have a history of stomach problems, such as ulcers or bleeding.

What should I do if pain or fever persists?

If pain worsens or lasts more than 10 days, or if fever persists for more than 3 days, stop use and consult a doctor.

Can I take Ibuprofen with other medications?

Consult a doctor or pharmacist before using Ibuprofen if you are taking other medications, especially if you are on aspirin for heart conditions.

What are the storage instructions for Ibuprofen?

Store Ibuprofen at 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 identified by the SPL code 34089-3. It is available in a dosage form of 200 mg. The chemical designation for this compound is L9082-250-46-0, which is consistent across different labeling formats, including both PDP and DF.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, menstrual cramps, 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 administered. However, it is imperative that the total dosage does 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 before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

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

The use of ibuprofen, an 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 disorders, are taking anticoagulants or steroid medications, are using 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.

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.

Ibuprofen should not be used in individuals who have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer, nor should it be administered immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a doctor prior to use if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies, or if they have a history of gastrointestinal issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as well as those taking diuretics, should also seek medical advice before using ibuprofen.

Patients should also consult a doctor or pharmacist before use if they are under medical care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

When using ibuprofen, it is recommended to take the medication with food or milk to mitigate potential stomach upset.

Patients should discontinue use and seek medical attention 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, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should consult a healthcare professional.

For pregnant or breastfeeding individuals, it is crucial to seek guidance from a healthcare professional before using ibuprofen. It is particularly important 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.

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 history of allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients aged 60 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 this adverse reaction.

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, and the risk escalates with higher doses or extended duration of use.

Patients are advised not to use ibuprofen if they have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer, or if they are undergoing heart surgery.

Before using ibuprofen, patients should consult a healthcare provider if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, those taking diuretics or aspirin for cardiovascular protection should seek medical advice, as ibuprofen may diminish the effectiveness of aspirin.

While using ibuprofen, it is recommended to take the medication with food or milk to mitigate potential stomach upset.

Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, 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.

Drug Interactions

Ibuprofen has been shown to potentially 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 patients. Monitoring for cardiovascular outcomes may be warranted in individuals 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. If pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is important not to exceed 6 tablets 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. It is essential for healthcare providers to exercise caution when prescribing to this population, as the likelihood of adverse effects and complications may be heightened in geriatric patients.

Close monitoring for side effects is recommended, and healthcare providers should consider potential dose adjustments based on the individual patient's health status and response to treatment. Careful assessment of the risks versus benefits is crucial when treating elderly patients with this product.

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 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used in higher than directed doses or for extended periods. It is important to note that reports of adverse reactions may not reflect the frequency of occurrence in the general population.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action in such situations.

Storage and Handling

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

Additional Clinical Information

The route of administration for the medication is oral. 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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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.