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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
May 16, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule
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 2020
Label revision date
May 16, 2022
Manufacturer
Aurohealth LLC
Registration number
ANDA207753
NDC root
58602-843
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (13 NDCs)
Packaging & NDC Codes (13)

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Drug Overview

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200 mg capsules. It is commonly used to temporarily relieve minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and pain associated with the common cold. Additionally, ibuprofen can help 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 discomfort from the common cold. It can also help with minor pain associated with arthritis.

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 the 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 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 giving this medication to a child under 12 years old, it's essential to consult with a doctor first. Always prioritize safety and follow these guidelines closely.

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 this medication right before or after heart surgery, as it may pose serious risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in individuals 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 three or more alcoholic drinks daily, 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, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, it's important to reach out to a healthcare professional. Pregnant or breastfeeding individuals should consult a healthcare provider before using ibuprofen, especially after 20 weeks of pregnancy, due to potential risks to the unborn child or complications during delivery.

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 any skin issues, stop using ibuprofen immediately and seek medical help. Additionally, this medication can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or exceed the recommended dosage.

There is also an increased risk of heart attack and stroke associated with ibuprofen use, particularly if taken in higher amounts or for extended periods. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or difficulty breathing, stop using ibuprofen and contact your doctor right away. For any overdose situation, seek emergency medical assistance or call Poison Control at 1-800-222-1222. If you are pregnant or breastfeeding, consult a healthcare professional before using ibuprofen, especially after 20 weeks of pregnancy, as it may pose risks to your baby.

Overdose

Taking too much ibuprofen can be very harmful. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, drowsiness (feeling unusually sleepy), headache, and confusion. In more serious situations, an overdose can lead to kidney failure, liver damage, and gastrointestinal bleeding (bleeding in the stomach or intestines).

If you suspect an overdose, it’s crucial to seek emergency medical help right away. Don’t wait for symptoms to worsen; getting prompt treatment can make a significant difference in recovery. Always keep medications out of reach and follow the recommended dosages to avoid these risks.

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 you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is one 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 sure not to exceed six capsules in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This warning is particularly relevant if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that prevent blood clots), steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or if you consume three or more alcoholic drinks daily while using this medication.

To help protect your health, make sure to follow the recommended dosage and duration of use. Taking more than directed or for an extended period can also raise your risk of complications. Always consult with your healthcare provider about your medications and any concerns you may have, especially if you fall into these higher-risk categories.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Moreover, using nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, can raise the risk of serious heart issues, such as heart attack, heart failure, and stroke, especially if taken in higher doses or for longer than recommended. Always discuss your current medications and any lab tests with your healthcare provider to ensure your safety and the effectiveness of your treatment.

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

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?

Ibuprofen is a pain reliever and fever reducer classified as a nonsteroidal anti-inflammatory drug (NSAID). It is available in 200 mg capsules.

What conditions does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains from headaches, toothaches, backaches, menstrual cramps, muscular aches, the common cold, 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 capsule every 4 to 6 hours while symptoms persist, not exceeding 6 capsules in 24 hours unless directed by a doctor.

What should I do if pain or fever does not respond to 1 capsule?

If pain or fever does not respond to 1 capsule, you may take 2 capsules, but do not exceed the maximum dosage.

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, especially if used more than directed.

What should I do if I experience signs of stomach bleeding?

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve, stop use and seek medical help immediately.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. Avoid using Ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

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

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

How should I store Ibuprofen?

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

What should I do if I have questions about using Ibuprofen?

If you have any questions or concerns about using Ibuprofen, consult a healthcare professional for guidance.

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

AUROHEALTH Ibuprofen Capsules are formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each capsule contains 200 mg of ibuprofen. The product is packaged in a bottle containing 40 liquid-filled capsules. The National Drug Code (NDC) for this formulation is 58602-843-12.

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, muscular aches, the common cold, 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. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative that the total dosage does 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 other pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 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 disorders, are concurrently 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 escalates with the use of higher doses or prolonged treatment.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (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 include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional prior to use. Special caution is advised against the use of 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 the potential for serious adverse reactions, including severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Individuals with a known allergy to aspirin are particularly at risk.

The use of ibuprofen, an NSAID, carries a warning for the potential 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, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or exceeding the recommended dosage. Patients should seek medical attention if they experience symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional prior to use. Ibuprofen should generally be avoided 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 Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Antiplatelet Agents Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin in patients requiring antiplatelet therapy.

Interactions with Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids is associated with an increased risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Cardiovascular Risks with NSAIDs The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen (excluding aspirin), is linked to an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of NSAID therapy and consider the lowest effective dose for the shortest duration possible to mitigate these risks.

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. If 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 years and older, are at an increased risk of severe stomach bleeding. This risk is further heightened in individuals who have a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription.

Additionally, the risk of stomach bleeding is amplified in geriatric patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to elderly patients. Dose adjustments may be necessary based on individual risk profiles to ensure safety and minimize potential adverse effects.

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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be considered as part of standard clinical practice.

Overdosage

Overdosage of ibuprofen can result in significant health risks and serious harm to the patient. Healthcare professionals should be vigilant in recognizing the symptoms associated with an overdose and taking appropriate action.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity depending on the amount ingested and the individual patient's response.

Severe Complications In more severe cases, an overdose of ibuprofen can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical intervention and can have long-lasting effects on the patient's health.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek emergency medical attention without delay. Prompt assessment and management are crucial to mitigate the potential adverse effects associated with overdose. Healthcare professionals should be prepared to provide supportive care and monitor the patient for any signs of severe complications.

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, severe stomach bleeding has been noted. There is also an increased risk associated with heart attack, heart failure, and stroke.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional prior to use. It is particularly crucial to inform patients that ibuprofen should not be used at 20 weeks of pregnancy or later unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Additionally, patients should be instructed to take the medication with food or milk if they experience any stomach upset.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled 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 medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.