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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
June 18, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
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 2013
Label revision date
June 18, 2013
Manufacturer
Discount Drug Mart
Registration number
ANDA091237
NDC root
53943-115
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Ibuprofen tablets are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use ibuprofen to temporarily alleviate minor aches and pains caused by various conditions, including backaches, headaches, menstrual cramps, arthritis, muscular aches, toothaches, and even discomfort from the common cold.

In addition to pain relief, ibuprofen is also effective in lowering fever, making it a versatile option for managing both pain and elevated body temperature. Each package contains 100 coated tablets, providing you with a convenient supply for your needs.

Uses

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

This medication is designed to provide you with quick relief from these common ailments, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

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

For children under 12 years old, it’s best to consult with a doctor before giving them this medication. This ensures that they receive the appropriate dosage and care based on their specific needs. Always follow your healthcare provider's instructions for safe and effective use.

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, do not take it right before or after heart surgery, as this could pose serious risks to your health.

It's important to be aware that there are potential risks associated with the abuse or misuse of this medication, as well as concerns about dependence (which means relying on the medication to function normally). Always follow these guidelines to ensure your safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of an allergic reaction may include wheezing (asthma), blisters, facial swelling, hives, rash, shock, and skin reddening. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID), may increase the risk of stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having black or bloody stools. If your pain worsens, lasts more than 10 days, or if you develop new symptoms, consult your doctor. Always talk to your healthcare provider before using ibuprofen if you have any existing health issues or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction may include wheezing, blisters, facial swelling, hives, rash, shock, or skin reddening. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also increase the risk of 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. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black or bloody stools, stop taking ibuprofen and call your doctor right away. Additionally, contact your doctor if your pain worsens or lasts more than 10 days, if your fever persists for more than three days, or if you experience any new symptoms.

In case of an overdose, it is crucial to get emergency medical help or contact a Poison Control Center immediately.

Overdose

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

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in treatment and recovery.

Pregnancy Use

Before using any medication, including ibuprofen, it's crucial to consult with a healthcare professional, especially if you are pregnant or planning to become pregnant. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it. This is important because 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 guidance.

Lactation Use

Before using any medication while breastfeeding, it's important to consult with a health professional. This is especially crucial if you are in the last three months of pregnancy, as certain medications, like ibuprofen, 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 doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, the recommended dosage is one tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give two tablets instead. However, be sure not to exceed six tablets 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 health considerations when taking medications. If you are 60 years or older, you should consult with your doctor before using this medication. This is especially crucial because older adults have a higher risk of stomach bleeding, which can be a serious side effect.

Always prioritize your health by discussing any medications with your healthcare provider, particularly if you are in this age group. They can help ensure that you use the medication safely and effectively, taking into account your unique health needs.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications. For instance, if you take ibuprofen along with aspirin for heart attack or stroke prevention, it may reduce the effectiveness of aspirin. Additionally, using other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescribed or over-the-counter, can heighten the risk of side effects.

If you are on blood thinners (anticoagulants) or steroid medications, combining them with ibuprofen could increase the risk of stomach bleeding. Furthermore, using ibuprofen continuously over a long period may raise your chances of having a heart attack or stroke. Always discuss your current medications and any potential interactions 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). This helps maintain its effectiveness and safety.

Before using the product, check the bottle cap for the seal marked “SEALED for YOUR PROTECTION.” 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 integrity of the device.

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 Tablets used for?

Ibuprofen Tablets are used to temporarily relieve minor aches and pains from conditions like backache, headache, menstrual cramps, arthritis, muscular aches, the common cold, and toothache, as well as to reduce fever.

What is the recommended dosage for adults and children 12 years and older?

You should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, you may take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should I do if I have an allergic reaction to pain relievers?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, and seek medical help immediately if an allergic reaction occurs.

Are there any warnings associated with taking Ibuprofen?

Yes, Ibuprofen may cause stomach bleeding, especially if you are 60 or older, have ulcers, or take blood thinners. You should stop use and call a doctor if you experience symptoms like fainting, vomiting blood, or have bloody stools.

Can I take Ibuprofen if I am pregnant?

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

What should I do if I experience severe side effects?

If you feel faint, have worsening pain, or notice any new symptoms, stop taking Ibuprofen and consult your doctor.

How should I store Ibuprofen Tablets?

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

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, USP 200 mg, are nonsteroidal anti-inflammatory drug (NSAID) formulations indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen as the active ingredient. The product is supplied in a package containing 100 coated tablets, designed for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headache, menstrual cramps, minor pain of arthritis, muscular aches, the common cold, and toothache. 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 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does 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 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 any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery and cardiovascular stability.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. 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 stomach bleeding. The likelihood of experiencing this adverse effect is heightened in certain populations, including individuals aged 60 years or older, those with a history of severe stomach ulcers or bleeding disorders, and patients concurrently using anticoagulants or steroid medications. Additionally, the risk increases for individuals taking other NSAIDs (such as aspirin, ibuprofen, or naproxen) or consuming three or more alcoholic beverages daily while using this product. Prolonged use or exceeding the recommended dosage may further elevate the risk of stomach bleeding.

Healthcare professionals should advise patients to discontinue use and contact their physician if they experience any of the following symptoms: feeling faint, vomiting blood, or passing bloody or black stools, which may indicate stomach bleeding; worsening pain that persists beyond 10 days; fever that worsens or lasts more than 3 days; exacerbation of stomach pain or upset; redness or swelling in the affected area; or the emergence of any new symptoms.

In cases of suspected overdose, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, 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 asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential stomach bleeding. The risk of this serious adverse reaction is heightened in patients who are aged 60 or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, or passing bloody or black stools. If any of these symptoms occur, patients should stop use and consult a healthcare professional.

Common adverse reactions may include gastrointestinal discomfort, such as stomach pain or upset, which can worsen or persist. Patients are advised to seek medical advice if pain lasts more than 10 days, fever worsens or lasts more than 3 days, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of serious side effects from pain relievers or fever reducers, ongoing stomach issues (such as heartburn or ulcers), bleeding disorders, high blood pressure, heart or kidney disease, or if they are taking diuretics. Additionally, patients should inform their healthcare provider if they are currently using other NSAIDs, anticoagulants, or steroids, or if they are under medical care for any serious condition. Special caution is advised for those 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 implications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen can diminish the cardioprotective effects of aspirin when both are used concurrently for the prevention of heart attacks or strokes. Therefore, it is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

The concomitant use of ibuprofen with other NSAIDs, whether prescription or over-the-counter, may elevate the risk of adverse effects associated with NSAID therapy. Caution is recommended, and healthcare providers should consider alternative pain management strategies or closely monitor patients for potential side effects.

Anticoagulants and Corticosteroids The use of ibuprofen alongside anticoagulants or corticosteroids may heighten the risk of gastrointestinal bleeding. It is essential for healthcare professionals to assess the necessity of ibuprofen in patients receiving these medications and to implement appropriate monitoring for signs of bleeding.

Cardiovascular Risks Long-term continuous use of ibuprofen has been associated with an increased risk of cardiovascular events, including heart attack and stroke. Clinicians should evaluate the risk-benefit ratio for patients requiring prolonged ibuprofen therapy and consider alternative treatments when appropriate. Regular monitoring of cardiovascular health 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 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important to note that the maximum dosage should not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding associated with the use of this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Before initiating therapy, it is advisable for elderly patients to consult with their healthcare provider, especially if they are 60 years of age or older. This precautionary measure is critical to ensure appropriate monitoring and to evaluate the potential risks versus benefits of the medication in this population.

Healthcare providers should remain vigilant regarding the safety profile of the medication in elderly patients and consider any necessary dose adjustments or additional monitoring to mitigate risks.

Pregnancy

Pregnant patients 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. The potential adverse effects on fetal outcomes and the delivery process necessitate careful consideration and professional guidance in managing pain or inflammation in pregnant individuals.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when recommending this medication to lactating mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

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

Severe Complications In more severe cases, an overdose may lead to critical complications such as kidney failure, liver damage, or gastrointestinal bleeding. These conditions require immediate medical intervention and monitoring.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek immediate medical attention. Prompt evaluation and treatment are essential to mitigate the risks associated with overdose and to manage any arising complications effectively.

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 detailed findings 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 the product. Notable gastrointestinal events, including gastrointestinal bleeding, have been reported. Additionally, renal impairment and cardiovascular events have been documented in the postmarketing surveillance.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Cases of liver enzyme elevations and instances of liver failure have been noted in the postmarketing data. Furthermore, anaphylactic reactions, including shock, have been observed. There have been reports of asthma exacerbation in patients with a prior history of asthma.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Patients should be informed of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, or experiencing bloody or black stools. They should be instructed to monitor their pain levels, and if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, they should contact their healthcare provider.

Patients should also be made aware that worsening or persistent stomach pain or upset, as well as any redness or swelling in the painful area, warrants further evaluation. They should be encouraged to report any new symptoms that may arise during treatment.

To minimize gastrointestinal discomfort, patients should be advised to take the medication with food or milk if they experience stomach upset. It is important to discuss the risks associated with long-term continuous use, which may increase the likelihood of heart attack or stroke.

Healthcare providers should recommend that patients consult with a doctor before using the medication if they have a history of problems or serious side effects from pain relievers or fever reducers. Additionally, patients with ongoing or recurrent stomach issues, such as heartburn, upset stomach, or stomach pain, should seek medical advice prior to use. Those with a history of ulcers, bleeding problems, high blood pressure, or heart or kidney disease should also be encouraged to consult their healthcare provider.

Patients aged 60 or older, or those who have taken a diuretic, should be advised to speak with their doctor before using the medication. Furthermore, it is essential to recommend that patients consult with a doctor or pharmacist if they are taking any other drugs containing NSAIDs, blood thinners (anticoagulants), or steroid medications. Patients under a doctor's care for any serious condition should also be encouraged to seek guidance before use. Lastly, patients taking aspirin for heart attack or stroke prevention should be informed that ibuprofen may diminish the effectiveness of aspirin and should consult their healthcare provider accordingly.

Storage and Handling

The product is supplied in a configuration that includes an NDC number, which is essential for identification and inventory management. It is crucial to store the product at a temperature range of 20-25 °C (68-77 °F) to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not used if the seal under the bottle cap, marked with “SEALED for YOUR PROTECTION,” is broken or missing, as this indicates potential tampering or contamination. Proper adherence to these storage and handling guidelines is vital for ensuring the integrity of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is particularly crucial 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 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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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.