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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 2011
Label revision date
December 21, 2021
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 2011
Label revision date
December 21, 2021
Manufacturer
MARKSANS PHARMA LIMITED
Registration number
ANDA091239
NDC roots
25000-114, 25000-117
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (17 NDCs)
Packaging & NDC Codes (17)

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Drug Overview

Ibuprofen Tablets USP, 200mg, are a type of medication that temporarily relieves minor aches and pains. You can use them for various discomforts, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. They are also effective for alleviating minor pain associated with arthritis and can help 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. Whether you're dealing with the common cold or just a tough day, ibuprofen can help you feel more comfortable.

Uses

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

This medication is designed to provide you with quick relief from discomfort, 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 a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

This medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be aware that using it improperly can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using this medication in ways not prescribed.

Side Effects

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

This medication can also lead to severe 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 recommended. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using ibuprofen and contact your doctor. Seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, or if you notice any new symptoms. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

Taking too much ibuprofen can lead to serious health issues. 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 severe cases, an overdose can result in kidney failure, liver damage, or gastrointestinal bleeding.

If you suspect an overdose, it’s crucial to seek immediate medical attention or contact a poison control center. Acting quickly can help prevent more serious complications. Always prioritize safety and don’t hesitate to reach out for help if you’re concerned.

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 particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

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 if you are 20 weeks pregnant or later, as using ibuprofen during this time 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 you are considering this medication for your child, it's important to know that it is recommended for use in children aged 12 years and older. For children under 12, you should consult a doctor before giving them this medication.

When administering the medication to children aged 12 and older, the typical dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets, but be careful not to exceed 6 tablets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, the risk of severe stomach bleeding increases, so it's crucial to monitor any symptoms and consult your doctor if you have concerns. Additionally, if you have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, be sure to discuss these with your healthcare provider before starting any new medication.

It's also essential to follow dosage instructions carefully. Using more than the recommended amount or taking a medication for longer than advised can raise the risk of heart attack and stroke, especially in older adults. Always prioritize open communication with your doctor to ensure your safety and well-being.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Moreover, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can raise your chances of experiencing serious heart issues, such as heart attacks or strokes, especially if you take them for longer than recommended. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use: do not use the product if the carton is opened or if the seal under the bottle cap, marked with “SEALED for YOUR PROTECTION,” is broken or missing.

Additionally, always refer to the end panel for the lot number and expiration date to confirm that the product is still within its safe usage period. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Ibuprofen Tablets USP used for?

Ibuprofen Tablets USP, 200mg, 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 have an allergic reaction to ibuprofen?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using ibuprofen and seek medical help immediately.

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

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.

Is ibuprofen safe to use during pregnancy?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

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

Stop using ibuprofen and contact your doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Who should not use ibuprofen?

Do not use ibuprofen if you have ever had an allergic reaction to it or any other pain reliever/fever reducer, or if you are about to have heart surgery.

What are the storage instructions for ibuprofen?

Store ibuprofen between 20-25°C (68-77°F). Do not use if the carton is opened or 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 are available in a dosage strength of 200 mg. The product is identified by multiple National Drug Codes (NDC), including 25000-114-03, 25000-117-03, 25000-114-70, 25000-114-14, 25000-114-71, 25000-117-14, 25000-117-69, 25000-114-02, and 25000-117-02. The formulation is offered in both standard tablet and caplet forms.

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 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 prior to administration.

Contraindications

Use 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 used immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with prolonged use or exceeding the recommended dosage.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also seek medical advice 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.

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, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, including ibuprofen, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

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, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using 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 applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek guidance if taking a diuretic or if under a physician's care for any serious condition.

Patients taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin, and should consult a healthcare professional before use.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for this purpose to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications can elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

Cardiovascular Risks with NSAIDs The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider the lowest effective dose for the shortest duration possible.

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. The product is recommended for adults and children aged 12 years and older.

For dosing in pediatric patients aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. 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 exercise caution and consider this heightened risk when prescribing to geriatric patients.

Before initiating treatment, healthcare providers should inquire about any pre-existing conditions in elderly patients, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These factors may necessitate closer monitoring or alternative therapeutic strategies.

Additionally, the risk of heart attack and stroke is elevated in elderly patients who exceed the recommended dosage or duration of use. Therefore, it is crucial to adhere strictly to prescribed dosages and to regularly assess the ongoing need for treatment in this population to mitigate potential cardiovascular risks.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy 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 at 20 weeks of gestation or later 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 weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

There is no specific information available 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 adverse effects that require prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe instances, the overdose may escalate to critical conditions such as kidney failure, liver damage, or gastrointestinal bleeding.

Recommended Actions In the event of a suspected overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a poison control center for further guidance and management. Timely intervention is crucial to mitigate the potential complications associated with ibuprofen overdosage.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, users of other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with prolonged use or higher than directed doses.

Patient Counseling

Healthcare providers should advise patients 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.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, they should discuss any concerns related to stomach bleeding, especially if they have a history of stomach issues such as heartburn.

It is important for patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke to inform their healthcare provider prior to use. Patients taking diuretics should also seek guidance from their healthcare provider.

Furthermore, patients should be advised to consult with their doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in these cases. Those under a doctor’s care for any serious condition or taking any other medications should also seek professional advice before use.

Storage and Handling

The product is supplied in a carton that must remain unopened for safe use. It is essential to check that the seal under the bottle cap, marked with “SEALED for YOUR PROTECTION,” is intact before use. The product should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. For reference, the lot number and expiration date can be found on the end panel of the carton.

Additional Clinical Information

No further data are available.

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.