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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
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
April 25, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
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 2023
Label revision date
April 25, 2023
Manufacturer
P & L Development, LLC
Registration number
ANDA202300
NDC root
59726-123
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 capsules (200 mg) are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use ibuprofen to temporarily alleviate minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

In addition to pain relief, ibuprofen is effective in lowering fever, making it a versatile option for managing discomfort and illness. Always ensure you follow the recommended guidelines for use to achieve the best results.

Uses

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

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, it’s important to follow the directions carefully. You should take the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the recommended dosage is to take 1 capsule every 4 to 6 hours as needed while symptoms persist. If you find that 1 capsule isn’t enough to relieve your pain or fever, you can take 2 capsules. However, make sure not to exceed 6 capsules 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 best to consult with a doctor first to ensure it’s safe and appropriate for them. Always remember to take the medication as directed to avoid any potential risks.

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 medical history and the use of this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or use it for longer than recommended. There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain, difficulty breathing, or weakness on one side of your body. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, 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, shock, skin reddening, 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.

You should seek emergency medical help if you suspect an overdose or contact a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, or if you notice any new symptoms.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s crucial to consult with a healthcare professional before using 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 seek guidance from your doctor to ensure the safety of both you and your baby.

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, the recommended dosage is one capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give two capsules, but be careful not to exceed six capsules in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, you may have a higher chance of experiencing severe stomach bleeding. Additionally, using medications beyond the recommended dose or for longer than advised can increase your risk of heart attack, heart failure, and stroke.

To help prevent stomach upset, consider taking your medication with food or milk, especially if you have a sensitive stomach. It's also wise to consult your doctor before starting any new medication if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have previously had a stroke, as these conditions are more common in older adults.

Renal Impairment

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

Drug Interactions

It's important to be aware of how different medications can interact with each other. For instance, if you take aspirin to help prevent heart attacks or strokes, using ibuprofen (a common pain reliever) at the same time may reduce the effectiveness of the aspirin. This means you might not get the full protective benefits of the aspirin when combined with ibuprofen.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs like ibuprofen. They can help you understand potential interactions and ensure that your treatment plan is safe and effective for your health needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 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, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's integrity.

Additional Information

No further information is available.

FAQ

What is Ibuprofen Capsules used for?

Ibuprofen Capsules are used to temporarily relieve minor aches and pains from headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. They also temporarily reduce fever.

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

Adults and children 12 years and over should take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, you may take 2 capsules, but do not exceed 6 capsules 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. It's important to stop use and seek medical help if you experience symptoms like chest pain, trouble breathing, or signs of stomach bleeding.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Ibuprofen. It is especially important 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?

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

How should I store Ibuprofen Capsules?

Store Ibuprofen Capsules at 20° to 25°C (68° to 77°F) and avoid excessive heat above 40°C (104°F).

Who should not use 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.

What should I do if I take too much Ibuprofen?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 Capsules contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These capsules are formulated as softgels, which are liquid-filled capsules designed for easy swallowing and rapid absorption.

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 ache, 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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, the total dosage must not exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect 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.

Additionally, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment beyond the recommended duration.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 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. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Furthermore, 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 seek medical advice promptly.

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), shock, skin reddening, rash, and blisters.

The use of ibuprofen is associated with a risk of severe stomach bleeding, particularly 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, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen carries a warning regarding an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with prolonged use or higher than recommended dosages. Patients should seek medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond three days, or the presence of redness or swelling in the affected area. Patients are advised to discontinue use and consult a healthcare professional if any new symptoms arise.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients under a doctor's care for serious conditions or those taking aspirin for cardiovascular protection discuss their use of ibuprofen, as it may diminish the effectiveness of aspirin.

Drug Interactions

The concomitant use of aspirin and ibuprofen may diminish the cardioprotective effects of aspirin. This interaction is particularly relevant for patients taking aspirin for the prevention of heart attacks or strokes. It is advisable to separate the administration of these medications to optimize the therapeutic benefits of aspirin.

No specific laboratory test interactions have been identified in the available data.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dose of 2 capsules may be administered. It is important not to exceed 6 capsules 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 when using this medication. Additionally, the likelihood of experiencing serious cardiovascular events, such as heart attack, heart failure, and stroke, is heightened in older adults, especially if the medication is used in excess or for prolonged periods beyond the recommended duration.

For geriatric patients who may experience stomach upset, it is advisable to take the medication with food or milk, as this may help mitigate gastrointestinal discomfort, which can be more pronounced in this population due to increased sensitivity.

Furthermore, it is essential for elderly patients to consult a healthcare provider prior to initiating therapy, particularly if they have a history of gastrointestinal issues, hypertension, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke. These conditions are more prevalent among older adults and may necessitate careful monitoring or dose adjustments to ensure safety and efficacy.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless explicitly directed by a physician. The use of ibuprofen during this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, healthcare providers should carefully evaluate the benefits and risks when considering ibuprofen for 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 function and associated health conditions.

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 at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported. Anaphylactic reactions, including angioedema and bronchospasm, have been noted in the postmarketing data. Furthermore, there are reports of hypertension and heart failure associated with the use of ibuprofen.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. It is also important to instruct patients to avoid using the medication right before or after heart surgery.

Patients should be made aware of the signs of stomach bleeding and instructed to stop use and consult a doctor if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should be cautioned to stop use and seek medical advice if they exhibit symptoms of heart problems or stroke, including chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling.

Healthcare providers should emphasize that patients must stop use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise. When using this product, patients should be advised to take it with food or milk if they experience stomach upset.

Patients should be encouraged to ask a doctor before use if the stomach bleeding warning applies to them, or if they have a history of stomach problems such as heartburn. It is also essential to recommend that patients consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Furthermore, patients should be advised to seek medical guidance if they are taking a diuretic or if they are under a doctor's care for any serious condition.

Finally, healthcare providers should inform patients to consult a doctor or pharmacist before use if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. Patients should also be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist.

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

No further data are available.

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.