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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 3, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 3, 2023
Manufacturer
Shandong Xinhua Pharmaceutical Co. , Ltd.
Registration number
ANDA207095
NDC roots
58624-7007, 58624-7009, 58624-7011
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen is a medication commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It is also effective in reducing fever. Available in various colors and sizes, ibuprofen tablets can be identified by their distinct shapes and markings.

This medication works by blocking certain substances in the body that cause inflammation and pain, helping you feel more comfortable during times of discomfort. Whether you're dealing with the common cold or arthritis-related pain, ibuprofen can provide relief when you need it.

Uses

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

This medication is designed to provide you with relief from discomfort, allowing you to feel more comfortable during everyday activities. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If you find that 1 caplet isn’t enough to relieve your pain or fever, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or 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 questions or concerns 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, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication can increase the risk of 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 exceed the recommended dosage.

There is also a risk of heart attack and stroke associated with NSAIDs like ibuprofen, which can be fatal if used improperly. You should stop using ibuprofen and seek medical help if you experience symptoms such as faintness, vomiting blood, bloody or black stools, chest pain, difficulty breathing, or any new or worsening symptoms. Always consult your doctor if you have a history of serious side effects from pain relievers, or if you have conditions like high blood pressure, heart disease, or asthma.

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 immediately and seek medical help. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. It’s important to note that using ibuprofen may increase the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have had allergic reactions to pain relievers, have stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics. If you are on aspirin for heart conditions, check with your doctor, as ibuprofen may reduce its effectiveness. If you suspect an overdose, contact a Poison Control Center or seek medical help immediately.

You should stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Also, seek medical attention if you have symptoms of heart problems or stroke, such as chest pain, trouble 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, contact your doctor.

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 reach out for professional assistance. 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. During the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically instructs you to do so, as it can potentially harm your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking professional advice.

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 guidance from your healthcare provider regarding any medications you may consider while breastfeeding.

Pediatric Use

If your child is 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 caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets. However, be sure not to exceed six caplets in a 24-hour period unless directed by a healthcare professional. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications like ibuprofen. If you are 60 or older, you have a higher chance of experiencing severe stomach bleeding, so it's crucial to take this medication with food or milk to help protect your stomach. Additionally, older adults face an increased risk of heart attack, heart failure, and stroke when using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.

To minimize these risks, always use the smallest effective dose. This approach is especially important for older adults, as it helps reduce the likelihood of side effects while still providing relief. If you have any concerns or experience stomach upset, consult your healthcare provider for guidance tailored to your 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 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 kidney health 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, including any other conditions you may have, like high blood pressure, heart disease, or kidney disease, to ensure the medication is safe for you.

Always prioritize open communication with your doctor about your liver health and any other medical issues, as this will help them determine the best treatment plan for you.

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. They can help ensure that your treatments work effectively together and keep you safe.

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). This helps maintain its effectiveness and safety.

Before using the product, check that the inner seal marked "SEALED for YOUR PROTECTION" is intact. If this seal is broken or missing, do not use the product, as it may not be safe. Always handle the product with care 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 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 is used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

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

Stop using Ibuprofen and seek medical help if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

What are the dosage instructions for adults and children 12 years and older?

Take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may take 2 caplets, but do not exceed 6 caplets 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 it or any other pain reliever/fever reducer, or if you are using it right before or after heart surgery.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Ibuprofen, especially during the last 3 months of pregnancy, as it may cause problems for the unborn child or complications during delivery.

What are the potential side effects of Ibuprofen?

Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Symptoms of an allergic reaction include hives, facial swelling, and difficulty breathing.

How should I store Ibuprofen?

Store Ibuprofen between 20-25°C (68-77°F) and do not use it if the inner seal is broken or missing.

What should I do if I have high blood pressure or other serious conditions?

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

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 tablets are available in three distinct colors and sizes. The orange capsule-shaped tablet is debossed with "BI 03" and is packaged in bottles of 24 (NDC 58624-7007-0). The white capsule-shaped tablet, debossed with "BI 05," is also supplied in bottles of 24 (NDC 58624-7009-0). Additionally, a brown capsule-shaped tablet, debossed with "BI 07," is available in bottles of 24 (NDC 58624-7011-0).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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, 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 elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should refrain from using ibuprofen if they have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. It is also contraindicated for use immediately before or after heart surgery. Prior to use, patients should consult a healthcare provider if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of gastrointestinal issues such as heartburn. Individuals 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 use.

Furthermore, patients taking aspirin for the prevention of heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin. It is advisable for patients under medical care for serious conditions or those taking other medications to discuss the use of ibuprofen with their doctor or pharmacist.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients are advised to 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 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 seek medical advice promptly.

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. Patients with a history of allergic reactions to ibuprofen or other pain relievers or fever reducers should avoid using this product.

The use of ibuprofen carries a significant 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 use other NSAIDs concurrently. 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, NSAIDs, including ibuprofen, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek immediate 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.

Patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 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.

It is contraindicated to use ibuprofen immediately before or after heart surgery. Patients should consult a doctor prior to use if they have a history of serious side effects from pain relievers, if the stomach bleeding warning applies, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Furthermore, patients taking diuretics or aspirin for cardiovascular protection should seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for cardiovascular protection. Monitoring for efficacy of aspirin therapy is recommended in such 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 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets 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. This warning is particularly relevant for individuals in this age group, necessitating careful monitoring for gastrointestinal side effects.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke in older adults. Therefore, healthcare providers should exercise caution when prescribing these medications to geriatric patients, ensuring that the benefits outweigh the risks.

To mitigate gastrointestinal discomfort, it is advisable for elderly patients to take ibuprofen with food or milk, as they may have more sensitive stomachs. Furthermore, it is essential to utilize the smallest effective dose for this population to minimize potential adverse effects. Regular assessment and monitoring of elderly patients on this medication are recommended to ensure their safety and well-being.

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 specifically 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, healthcare providers should weigh the potential benefits against any 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 specific restrictions 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 therapeutic approach.

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, as timely medical support can significantly influence outcomes. 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.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have documented gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious cardiovascular events, including heart attack and stroke, have also been reported.

Additionally, there have been cases of severe allergic reactions, such as anaphylaxis and angioedema. Instances of skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted. Elevated blood pressure has been observed in patients taking ibuprofen, along with cases of hepatotoxicity, including liver failure. Furthermore, reports of gastrointestinal perforation and ulceration have been documented, some of which were fatal.

Patient Counseling

Healthcare providers should advise patients to keep the 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 urgency of this action to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that includes an inner seal imprinted with "SEALED for YOUR PROTECTION." It is essential to ensure that this seal is intact before use, as a broken or missing seal indicates that the product should not be utilized.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to preserve 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 crucial to avoid ibuprofen during the last trimester 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.

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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.