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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 1999
Label revision date
August 6, 2010
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 1999
Label revision date
August 6, 2010
Manufacturer
DOLGENCORP, LLC
Registration number
ANDA075139
NDC root
55910-392
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 available in 200 mg tablets that serves as a pain reliever and fever reducer. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can use ibuprofen to temporarily relieve minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, it helps to temporarily reduce fever.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. If you're looking for a way to manage discomfort or fever, ibuprofen may be a suitable option for you.

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 minor arthritis pain. It can also help ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, it’s important to follow the instructions carefully. You should take the smallest effective dose and not exceed the recommended amount. For adults and children aged 12 years and older, the typical dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If your pain or fever doesn’t improve with 1 tablet, you can take 2 tablets, but make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

You should not use this medication for more than 10 days unless directed by a healthcare professional. If you are giving this medication to a child under 12 years old, it’s best to consult a doctor first. Always remember to take the tablets by mouth, and only take them as often as needed while your symptoms last.

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, or if you are scheduled to have heart surgery, either right before or after the procedure.

Be cautious, as using this medication in higher amounts or for longer than recommended can increase your risk of serious issues, such as heart attack or stroke. It's important to follow the prescribed directions closely to minimize these risks.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or 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. If you experience symptoms like feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor immediately.

It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. You should also inform your doctor if you are taking other medications, especially blood thinners or diuretics, as these can increase the risk of side effects.

Warnings and Precautions

You should be aware that ibuprofen can cause severe allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction 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.

Ibuprofen can also increase the risk of serious 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 it for longer than directed. Before using ibuprofen, consult your doctor if any of these conditions apply to you, or if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, if you are under a doctor's care for a serious condition or taking aspirin for heart health, check with your doctor or pharmacist first.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. You should also 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. Additionally, contact your doctor if your pain worsens or lasts more than 10 days, your fever worsens or lasts more than 3 days, you see redness or swelling in the painful area, or if any new symptoms arise.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait for symptoms to worsen; acting quickly can be vital. Always prioritize your safety and the safety of others by getting professional assistance as soon as possible.

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 crucial to ensure the safety of both you and your baby.

Particularly during the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so. Using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

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 your baby's well-being by seeking guidance from your doctor.

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 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets. However, make sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

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 means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking. They can help you understand the risks and adjust dosages or suggest alternatives that are safer for older adults. Your health and safety are the top priority, so don't hesitate to ask questions and seek guidance.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, and asthma can complicate your kidney issues. It's essential to monitor your kidney function regularly, especially if you are taking medications that may impact your kidneys.

Make sure to discuss any necessary dosage adjustments with your healthcare provider, as they may need to modify your treatment based on your kidney function. Keeping an open line of communication with your doctor will help ensure that your health is managed effectively.

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 keep your doctor informed about any existing health issues, including high blood pressure, heart disease, kidney disease, or asthma, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take aspirin to prevent heart attacks or strokes, using ibuprofen (a common pain reliever) at the same time may reduce the effectiveness of the aspirin. Additionally, combining ibuprofen with blood thinners (medications that help prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding.

Moreover, using ibuprofen for longer than recommended 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 the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to avoid exposing it to excessive heat, which means keeping it below 40°C (104°F). Always check the end flap for the expiration date and lot number to ensure you are using a safe and effective product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

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 a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, 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 tablet every 4 to 6 hours while symptoms persist, with a maximum of 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding symptoms?

Stop use and ask a doctor if you experience symptoms like feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin, and it can increase the risk of stomach bleeding, particularly in older adults or those with certain medical conditions.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use Ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have a history of stomach problems?

You should ask a doctor before using Ibuprofen if you have a history of stomach problems, such as ulcers or bleeding, or if you are taking other medications that may increase the risk of bleeding.

How should I store Ibuprofen?

Store Ibuprofen at controlled room temperature and avoid excessive heat above 40°C (104°F).

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

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 is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. It is formulated as coated tablets, each containing 200 mg of ibuprofen. The product features a tamper-evident design, and it is advised not to use the product if the imprinted safety seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular 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

The medication should be administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If the initial dose of 1 tablet does not adequately relieve pain or fever, a dose of 2 tablets may be taken. However, the total daily dosage must not exceed 6 tablets 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 before administration. It is important to use the smallest effective dose and to avoid taking the medication for longer than 10 days unless specifically instructed by a healthcare provider.

Contraindications

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

Caution is advised as exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

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, 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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are currently taking a diuretic. Additionally, patients should seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are using aspirin for cardiovascular protection, or are taking any other medications.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients are advised to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, medical consultation is warranted.

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.

Additionally, ibuprofen carries a warning regarding the risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using the product. Patients who take other NSAIDs, whether prescription or over-the-counter, are also at increased risk.

Patients should discontinue use and consult a healthcare professional 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. Other reasons to seek medical advice include worsening pain lasting more than 10 days, a fever that worsens or lasts more than three days, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable to seek medical advice if the patient is under a doctor's care for any serious condition or is taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular protection, may diminish the therapeutic efficacy of aspirin. This interaction is clinically significant for patients who are using aspirin for the prevention of heart attacks or strokes.

When ibuprofen is administered alongside anticoagulants or steroid medications, there is an increased risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients closely for signs of gastrointestinal complications when these medications are co-prescribed.

Additionally, prolonged use of ibuprofen beyond the recommended dosage may elevate the risk of cardiovascular events, including heart attack and stroke. It is advisable for clinicians to evaluate the necessity of ibuprofen therapy and to adhere strictly to dosing guidelines to mitigate these risks. Regular assessment of the patient's cardiovascular status may be warranted during extended treatment periods.

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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial to avoid the use of ibuprofen during the last trimester 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 evaluate the potential benefits and risks when considering the use of this medication in 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 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy, as changes in clearance may impact the pharmacokinetics of the medication. Healthcare professionals should remain vigilant in evaluating the overall health status of patients with renal impairment to optimize therapeutic outcomes.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition thoroughly and implement appropriate interventions based on clinical guidelines and the specific circumstances of the overdose.

In summary, immediate medical attention is essential in cases of overdose, and healthcare professionals should be prepared to provide comprehensive care and support to affected individuals.

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 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 indicate occurrences of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of cardiovascular events, such as myocardial infarction and stroke, have been reported. Some patients have experienced allergic reactions, including anaphylaxis and angioedema. Furthermore, instances of elevated blood pressure and gastrointestinal perforation have been noted in postmarketing surveillance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of timely intervention in such situations.

Patients should also be informed that if they experience stomach upset, taking the medication with food or milk may help alleviate discomfort. This guidance can enhance patient compliance and comfort during treatment.

Additionally, healthcare providers must communicate the potential risks associated with the medication, specifically the increased risk of heart attack or stroke. Patients should be cautioned against exceeding the recommended dosage or extending the duration of use beyond what is directed, as this may elevate their risk for serious cardiovascular events.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at controlled room temperature, ensuring that the storage environment does not exceed excessive heat above 40°C (104°F). For optimal product integrity, it is essential to check the end flap for the expiration date and lot number. Special handling precautions should be observed to maintain the quality and efficacy of the product throughout its shelf life.

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.

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.