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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2014
Label revision date
November 7, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2014
Label revision date
November 7, 2018
Manufacturer
Contract Pharmacal Corp.
Registration number
ANDA071265
NDC roots
10267-3846, 10267-3852, 10267-3909
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 Tablets, USP 200 mg, 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 headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help lower a fever.

This medication is similar to the active ingredient found in Motrin® IB and is designed to be gluten-free and dye-free, making it suitable for a variety of users. With 250 coated tablets in a package, ibuprofen provides a convenient option for managing everyday discomfort.

Uses

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

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

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 to do so.

For children under 12 years of age, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

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

If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop using the medication and consult your doctor immediately. You should also seek medical advice if you experience symptoms of heart problems or stroke, such as chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Furthermore, if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, if you see redness or swelling in the painful area, or if any new symptoms arise, please contact your healthcare provider.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. The risk of heart attack and stroke is also increased with ibuprofen use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications, especially aspirin.

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, 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 three or more alcoholic drinks daily, or use other NSAIDs (non-steroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

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 advice if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, if you see redness or swelling in the painful area, or if any new symptoms arise. In case of an overdose, get emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away.

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, vomiting, stomach pain, drowsiness, headache, or confusion. In more serious situations, an overdose can lead to kidney failure, liver damage, or gastrointestinal bleeding (bleeding in the digestive tract).

If you suspect an overdose, it’s crucial to seek emergency medical help right away. Don’t wait for symptoms to worsen; getting prompt treatment can make a significant difference in outcomes. Always remember to use medications as directed to avoid these risks.

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

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using 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 guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For children aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets, but be 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 of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk increases with the use of certain medications, so it's crucial to follow your healthcare provider's instructions carefully.

Additionally, older adults may face an increased risk of heart attack, heart failure, and stroke if medications are taken in higher doses or for longer periods than recommended. Always discuss your medication regimen with your doctor to ensure it is safe and appropriate for your age and health status.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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˚ to 25˚C (68˚ to 77˚F). It's important to avoid exposing it to excessive heat, as temperatures above 40˚C (104˚F) can damage the product.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

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 pose risks to your unborn child or lead to complications during delivery.

FAQ

What is Ibuprofen Tablets used for?

Ibuprofen Tablets are used to temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps, as well as to reduce fever.

How should I take Ibuprofen Tablets?

Adults and children 12 years of age and over 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.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increases the risk of heart attack and stroke. It's important to stop use and seek medical help if you experience symptoms like chest pain, trouble breathing, or signs of stomach bleeding.

Can I use Ibuprofen if I am pregnant or breastfeeding?

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

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

If you experience signs of stomach bleeding such as feeling faint, vomiting blood, or having bloody or black stools, you should stop taking Ibuprofen and call your doctor immediately.

Is Ibuprofen gluten-free?

Yes, Ibuprofen Tablets are gluten-free and dye-free.

What should I do in case of an overdose?

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

What age group should consult a doctor before using Ibuprofen?

Children under 12 years of age should ask a doctor before using Ibuprofen.

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 drugs (NSAIDs) indicated for the relief of pain and reduction of fever. Each bottle contains 250 coated tablets, which are formulated to be gluten-free and dye-free. The tablets are designed for oral administration and are intended for use as directed. The appearance of the tablets may not represent the actual size.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular ache, 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 of age and over 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 ibuprofen or any other pain reliever/fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications.

Patients should discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. 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 advice should be sought.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions 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 is associated with 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 concurrently using anticoagulants or steroid medications, are taking 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.

Furthermore, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment beyond the recommended guidelines.

Healthcare professionals should advise patients to discontinue use and consult a physician 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, patients should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be instructed to contact their healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

In cases of overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted 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 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 while using the product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, have been 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 persists beyond 10 days, fever worsens or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of 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. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use.

Patients taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin. It is also recommended that individuals under a physician's care for any serious condition or those taking other medications consult with a healthcare professional before using ibuprofen.

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have 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 bleeding and to consider the potential risks when prescribing.

Additionally, the risk of heart attack, heart failure, and stroke is heightened in geriatric patients who exceed the recommended dosage or duration of use. Therefore, it is crucial to adhere strictly to the prescribed guidelines and to evaluate the necessity of continued treatment in older adults regularly. Careful consideration of these factors is vital to ensure the safety and efficacy of the medication in this population.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use in late pregnancy warrant careful consideration and professional guidance.

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 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 ibuprofen 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 outlined 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 and serious harm. Healthcare professionals should be aware of the potential symptoms and management strategies associated with ibuprofen overdose.

Symptoms of Overdose Patients experiencing an 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 patient's response.

In more severe cases, ibuprofen overdose can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical intervention and monitoring.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek emergency medical attention without delay. Prompt assessment and treatment are crucial to mitigate the potential adverse effects associated with overdose. Healthcare providers should be prepared to initiate appropriate management protocols, which may include supportive care and monitoring of vital organ functions.

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 include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of anaphylactic reactions, including shock, have been reported.

Cardiovascular events, including myocardial infarction and stroke, have been noted in patients using ibuprofen. There have been instances of elevated blood pressure among these patients. Postmarketing surveillance indicates an increased risk of heart attack and stroke associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, particularly in individuals with pre-existing cardiovascular risk factors.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider before starting this medication.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to consult their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20˚ to 25˚C (68˚ to 77˚F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40˚C (104˚F), to maintain product integrity. Proper storage conditions are crucial to ensure the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.