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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 2019
Label revision date
December 6, 2018
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 2019
Label revision date
December 6, 2018
Manufacturer
AiPing Pharmaceutical, Inc.
Registration number
ANDA206990
NDC roots
11788-002, 11788-004, 11788-006
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Ibuprofen is a medication commonly used to temporarily relieve minor aches and pains, such as headaches, muscular aches, toothaches, backaches, and menstrual cramps. It is also effective in reducing fever. This medication works by blocking certain substances in the body that cause inflammation and pain, helping you feel more comfortable during times of discomfort.

Available in various forms, including orange, white, and brown round-shaped tablets, ibuprofen is a versatile option for managing everyday pain and fever.

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, providing you with comfort when you're feeling unwell.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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 you 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 could pose serious risks to your health. Always consult with your healthcare provider if you have any questions or concerns about your eligibility to use this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding issues, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

There are also warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can elevate these risks, particularly if used in higher doses or for extended periods. You should stop using ibuprofen and consult a doctor if you experience symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), signs of heart problems or stroke (like chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using ibuprofen, especially during the last three months of pregnancy, due to potential risks to the unborn child.

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. Additionally, this medication can lead to severe stomach bleeding, particularly 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 are also risks of heart attack and stroke associated with ibuprofen, especially if used in higher amounts or for longer than directed. You should not use ibuprofen if you have had an allergic reaction to it or other pain relievers, or if you are about to undergo heart surgery. Consult your doctor before using ibuprofen if you have any serious health conditions, such as high blood pressure, heart disease, or kidney issues, or if you are taking other medications.

While using ibuprofen, take it with food or milk to help prevent stomach upset. Stop using it and contact your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or weakness), or if your pain or fever worsens or lasts longer than expected. If you are pregnant or breastfeeding, consult a healthcare professional before use, especially during the last three months of pregnancy. Always keep ibuprofen out of reach of children, and in case of overdose, seek medical help or contact a Poison Control Center immediately.

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 crucial 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 lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

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 during the last three months of pregnancy, as using ibuprofen at this stage 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 professional advice.

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 have any questions about your child's health.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications like NSAIDs (nonsteroidal anti-inflammatory drugs), which include ibuprofen. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when using these medications. Additionally, using NSAIDs can increase your risk of heart attack, heart failure, and stroke, especially if you take more than the recommended dose or use them for an extended period.

To stay safe, always follow the dosage instructions provided by your healthcare provider and discuss any concerns you may have about using NSAIDs. Being mindful of these precautions can help you manage your pain while minimizing potential risks.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing your medical history with your doctor.

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. This is crucial to ensure your safety and the effectiveness of the treatment.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen. This way, you can ensure that your treatments work effectively and safely together.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to check the inner seal. If the seal is broken or missing and is marked with "SEALED for YOUR PROTECTION," do not use the product, as this could compromise its safety. Always follow these guidelines to ensure you are using the product safely and effectively.

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 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 headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. 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 warnings associated with Ibuprofen?

Ibuprofen may cause severe stomach bleeding, especially in those over 60 or with a history of stomach issues. It also increases the risk of heart attack and stroke.

How should I take Ibuprofen?

Adults and children 12 years and older should take 1 caplet every 4 to 6 hours while symptoms persist, not exceeding 6 caplets in 24 hours unless directed by a doctor.

Can I use Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. Avoid using Ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have a history of allergic reactions to pain relievers?

Do not use Ibuprofen if you have ever had an allergic reaction to it or any other pain reliever/fever reducer.

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

Stop using Ibuprofen and contact a doctor if you feel faint, vomit blood, or have bloody or black stools.

What are the storage instructions for Ibuprofen?

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

Is there a dosage recommendation for children under 12?

For children under 12 years, consult a doctor before use.

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, round-shaped tablet is debossed with "BI 02" and is packaged in bottles of 24 (NDC 11788-002-07) and 1000 (NDC 11788-002-10). The white, round-shaped tablet, debossed with "BI 04," is also offered in bottles of 24 (NDC 11788-004-07) and 1000 (NDC 11788-004-10). Additionally, the brown, round-shaped tablet, marked with "BI 06," is available in bottles of 24 (NDC 11788-006-07) and 1000 (NDC 11788-006-10).

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 aged 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 an allergic reaction 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 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 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.

NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

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

Healthcare professionals should advise patients to consult a doctor prior to use if they have experienced significant 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. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before using ibuprofen. Patients taking diuretics should also consult a healthcare provider.

It is essential to inform patients that if they are taking aspirin for the prevention of heart attack or stroke, ibuprofen may diminish the cardioprotective effects of aspirin. Patients under a physician's care for serious conditions or those taking other medications should also seek guidance from a doctor or pharmacist before using ibuprofen.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also stop use if pain worsens or persists for more than 10 days, if fever worsens 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 patients, it is crucial to consult a healthcare professional before use. Ibuprofen should be avoided 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.

Finally, ibuprofen must be kept out of reach of children. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center should be made (1-800-222-1222).

Side Effects

Patients may experience a range of adverse reactions while using ibuprofen, 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, as a nonsteroidal anti-inflammatory drug (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 problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended guidelines.

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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three 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. Ibuprofen should be avoided 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 Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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 otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

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. This risk is further heightened in elderly patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage and treatment duration is crucial in this population to mitigate potential adverse effects. Regular assessment and monitoring of cardiovascular health are advised for geriatric patients receiving NSAIDs.

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 healthcare professional before using this medication. It is particularly important to avoid the use of 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. 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 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 disclose any existing conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in this population to assess any potential impact on drug metabolism and overall safety. Adjustments to dosage or treatment regimens may be necessary 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, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious cardiovascular events, such as myocardial infarction and stroke, have also been documented. Instances of severe allergic reactions, including anaphylaxis and angioedema, have been reported.

Additionally, skin reactions have been noted, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme. Elevated blood pressure has been observed in some patients taking ibuprofen. Furthermore, postmarketing surveillance has recorded cases of hepatotoxicity, including liver failure.

Patient Counseling

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

Patients who are pregnant or breastfeeding should be encouraged to consult a healthcare professional before using this medication. It is particularly important to inform patients that ibuprofen should not be used during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in packaging that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it must not be utilized if the inner seal, which is imprinted with "SEALED for YOUR PROTECTION," is broken or missing. Proper handling and storage conditions are essential to maintain the integrity 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 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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.