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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
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 2022
Label revision date
December 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
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 2022
Label revision date
December 30, 2024
Manufacturer
SPIRIT PHARMACEUTICALS, LLC
Registration number
ANDA204469
NDC root
68210-4205
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 that temporarily relieves minor aches and pains caused by various conditions, such as headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. It is also effective in reducing fever. By working on the body's pain and inflammation pathways, ibuprofen helps you feel more comfortable during times of discomfort.

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 arthritis pain.

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical dosage is 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 essential to consult a doctor first. Additionally, you should not use this medication for longer than 10 days unless directed by a healthcare professional. Always prioritize your health and safety by following these guidelines.

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 risks to your health.

Be cautious about how you use this medication. Taking more than the recommended dose or using it for longer than directed can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety.

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, wheezing (asthma), 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 bleeding, or who consume alcohol regularly. The risk of heart attack and stroke is also increased with ibuprofen use, particularly if taken 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. It's also important to seek medical advice if your pain worsens or lasts more than 10 days, or if you develop new symptoms. Before using ibuprofen, talk to your doctor if you have any existing health issues, are taking other medications, or have concerns about potential side effects.

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. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal.

You should get emergency medical help if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and call your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having bloody or black stools), if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, or if you experience 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.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy 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 during the last three months of pregnancy, 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. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it can potentially cause issues for your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

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 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 old 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 that can affect the stomach.

Always consult with your healthcare provider about any medications you are taking, especially if you have concerns about stomach issues or bleeding. They can help you understand the risks and determine the best treatment options for your health needs.

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 existing conditions, including high blood pressure, heart disease, liver cirrhosis, or asthma, 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 (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 if you have any other health issues, including high blood pressure, heart disease, kidney disease, or asthma, as these can affect your treatment plan. Taking these precautions helps ensure your safety and the effectiveness of your medication.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and affect your health. For instance, if you're taking aspirin to prevent heart attacks or strokes, using ibuprofen may reduce its effectiveness. Additionally, if you're on blood thinners (medications that help prevent blood clots) or steroids, combining these with ibuprofen can increase your risk of stomach bleeding.

Moreover, using ibuprofen for longer than recommended or in higher doses can raise your chances of experiencing a heart attack or stroke. Always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider to ensure your safety and well-being.

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, which means keeping it away from temperatures above 40°C (104°F).

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 ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is Ibuprofen used for?

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

What should I do if I experience severe allergic reactions?

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

What are the risks of taking Ibuprofen?

Taking Ibuprofen may increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed. It may also cause severe stomach bleeding.

How should I take Ibuprofen?

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.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are about to have heart surgery.

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

If you feel faint, vomit blood, or have bloody or black stools, stop using Ibuprofen and call your doctor immediately.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen, especially during the last 3 months of pregnancy.

What should I do if I have high blood pressure or heart disease?

Ask a doctor before using Ibuprofen if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

What is the recommended storage for 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

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 administration guidelines. The smallest effective dose should be utilized, and the duration of use should not exceed 10 days unless otherwise directed by a healthcare professional.

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, the total daily dosage must not exceed 6 capsules within a 24-hour period unless specifically instructed by a physician.

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

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered 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. Should any signs of an allergic reaction manifest, 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 such an event is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroids, are taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher-than-recommended dosages.

In the event of an overdose, immediate medical attention is required. Healthcare professionals should contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients should 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, medical advice should be sought if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if stomach discomfort exacerbates or continues, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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 carries a significant risk of severe stomach bleeding, especially 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. The risk of gastrointestinal bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Additionally, NSAIDs, including ibuprofen, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for longer than directed.

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. Other concerning symptoms that warrant medical attention include worsening pain lasting more than 10 days, fever lasting more than 3 days, exacerbation of stomach pain or upset, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, suffer from stomach issues such as heartburn, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare provider if the patient is under medical care for any serious condition or is taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

Drug Interactions

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

Aspirin Interactions 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 for this purpose to ensure optimal therapeutic outcomes.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

Cardiovascular Risks Prolonged use of ibuprofen, particularly at doses exceeding the recommended guidelines, may increase the risk of cardiovascular events, including heart attack and stroke. It is essential to adhere to prescribed dosages and duration of therapy, and to evaluate the necessity of continued ibuprofen use in patients with existing cardiovascular risk factors. Regular monitoring and reassessment of therapy may be warranted in these cases.

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, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 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 during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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 during the last three months of pregnancy unless explicitly directed by a healthcare provider, 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 in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status and the severity of their kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific interventions as indicated by the clinical scenario. It is essential for healthcare providers to remain vigilant and prepared to implement necessary measures to ensure patient safety and recovery.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

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, 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 prolonged use or higher than directed doses.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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. Additionally, it is important to instruct patients to avoid using this product right before or after heart surgery.

Patients should be made aware of the signs of potential 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. They should also be advised to stop use and seek medical advice if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if stomach pain or upset worsens or persists, if redness or swelling occurs in the painful area, or if any new symptoms appear.

When using this product, patients should be counseled to take it with food or milk if they experience stomach upset. It is crucial to inform patients that the risk of heart attack or stroke may increase if they use more than the directed dose or for a longer duration than recommended.

Patients should be encouraged to consult a doctor before use if the stomach bleeding warning applies to them or if they have a history of problems or serious side effects from taking pain relievers or fever reducers. They should also seek medical advice if they have stomach issues, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Furthermore, patients should be advised 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. It is also important to recommend that patients speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking any other medications.

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 between 20° and 25°C (68° and 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 during the last three months 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.

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.