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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 2015
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 2015
Label revision date
December 21, 2021
Manufacturer
MARKSANS PHARMA LIMITED
Registration number
ANDA091237
NDC roots
25000-135, 25000-136
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (15 NDCs)
Packaging & NDC Codes (15)

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 200mg, are a type of medication commonly used to temporarily relieve minor aches and pains. This includes discomfort from headaches, muscular aches, toothaches, backaches, and menstrual cramps, as well as pain associated with arthritis and the common cold. Additionally, ibuprofen can help reduce fever.

The way ibuprofen works is 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 a headache or muscle soreness, ibuprofen can be a helpful option to consider.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever, providing you with comfort when you're feeling unwell.

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

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 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

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after heart surgery, as it may pose serious risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

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

Additionally, ibuprofen carries risks of stomach bleeding, especially for those over 60, with a history of stomach ulcers, or who take blood thinners or other NSAIDs. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. There is also an increased risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for extended periods. If you notice symptoms like chest pain, trouble breathing, weakness on one side of the body, or slurred speech, seek medical attention right away. Always consult your doctor if you have any pre-existing health conditions or are taking other medications.

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 ibuprofen immediately and seek medical help.

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 other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having 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 swelling in your legs. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, consult your doctor. In case of an overdose, get emergency medical help or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical attention immediately.

Signs of an overdose can vary, but common symptoms may include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure about your symptoms, do not hesitate to contact a healthcare professional or go to the nearest emergency room. Your safety is the top priority, so it's always better to err on the side of caution.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important 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 you should consult a doctor before using it for children under 12 years old. For children aged 12 and older, the recommended 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 prioritize safety and seek medical advice 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 is in this age group, you should be particularly cautious about medications that can affect the stomach. Older adults may also face a higher risk of other side effects, including issues related to the heart.

To ensure safety, it's recommended that the smallest effective dose of medication be used for older adults. Additionally, if you are caring for an elderly person, it's crucial to monitor them closely for any signs of gastrointestinal bleeding or other adverse effects. Keeping an eye on these potential issues can help manage health risks effectively.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using ibuprofen, especially if you are taking aspirin to prevent heart attacks or strokes. Ibuprofen can reduce the effectiveness of aspirin, which may affect your heart health. Always ensure that your healthcare provider is aware of all the medications you are taking to help manage your health safely.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25ºC (68-77ºF). 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 "SEALED for YOUR PROTECTION," is broken or missing.

Additionally, make sure to look for the lot number and expiration date on the end panel of the carton 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 200mg used for?

Ibuprofen Tablets, USP 200mg temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces 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 experience an allergic reaction?

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

Are there any warnings associated with taking ibuprofen?

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

Can I use ibuprofen if I am pregnant or breastfeeding?

You should ask a health professional before using ibuprofen if you are pregnant or breastfeeding, especially after 20 weeks of pregnancy, as it may cause complications.

What should I do if I overdose on ibuprofen?

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

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, high blood pressure, heart disease, or other serious conditions.

How should I store ibuprofen tablets?

Store ibuprofen tablets at 20-25ºC (68-77ºF) and 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 25000-136-03, 25000-135-03 (Caplets), 25000-136-69, 25000-136-14, 25000-136-71, 25000-135-14 (Caplets), 25000-135-70 (Caplets), 25000-136-02, and 25000-135-02 (Caplets). These tablets are formulated for oral administration and are characterized by their specific dosage form and appearance.

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 for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 ibuprofen, an 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 the use of higher than recommended doses or prolonged use.

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

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. Additionally, 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 this product may experience a range of adverse reactions, some of which can be serious.

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. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a 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, 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 greater when the product is used in higher doses or for extended periods.

Patients are advised to stop using the product 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, weakness on one side of the body, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice if their pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, 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 advisable to seek medical advice if they are taking a diuretic or if they are under a doctor's care for any serious condition.

Patients taking aspirin for the prevention of heart attack or stroke should consult a doctor or pharmacist before using this product, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Patients should consult a healthcare professional prior to using ibuprofen if they are concurrently taking aspirin for the prevention of heart attack or stroke. The concomitant use of ibuprofen may diminish the cardioprotective effects of aspirin, potentially reducing its efficacy in these clinical scenarios. Monitoring for cardiovascular outcomes may be warranted in patients receiving both medications.

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. 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 in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications, as the likelihood of adverse effects, including gastrointestinal bleeding and cardiovascular events, is greater in this population.

When treating geriatric patients, it is essential to utilize the smallest effective dose to minimize potential risks. Close monitoring for signs of gastrointestinal bleeding and other side effects is recommended to ensure patient safety. Healthcare providers should remain vigilant in assessing the overall health status of elderly patients and adjust treatment plans accordingly to mitigate any adverse outcomes.

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 after 20 weeks of gestation 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 weigh the potential benefits against the 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 pregnancy or later unless specifically 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in 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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures In the absence of specific antidotes or treatment protocols, the management of overdosage should focus on supportive care and symptomatic relief. Healthcare providers are encouraged to consult local poison control centers or toxicology experts for guidance tailored to the individual case.

It is imperative that healthcare professionals remain informed about the potential risks associated with overdosage and maintain a high index of suspicion when evaluating patients who may have ingested amounts exceeding the recommended dosage.

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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Cardiovascular events, including heart attack and stroke, have been noted. Gastrointestinal complications such as bleeding, ulceration, and perforation have also been reported. Instances of renal toxicity, including acute kidney injury, were observed, alongside hepatic toxicity characterized by elevated liver enzymes and liver failure.

Severe allergic reactions, including anaphylaxis and skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Additionally, exacerbation of asthma and other respiratory conditions has been reported. Other adverse reactions include dizziness, headache, and rash.

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. Patients should be instructed to take the medication with food or milk if they experience stomach upset.

Patients must be informed to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, they should stop use and seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important for patients to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if they observe redness or swelling in the area of pain. Patients should also be advised to seek medical attention if any new symptoms arise.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the warning regarding stomach bleeding is applicable to them. Patients with a history of stomach issues, such as heartburn, or those 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, patients taking diuretics or those under a doctor's care for any serious condition should be encouraged to seek medical advice before using the medication. It is also essential for patients taking aspirin for heart attack or stroke to consult a doctor or pharmacist, as ibuprofen may diminish the cardiovascular benefits of aspirin. Lastly, patients should be reminded to discuss any other medications they are taking with their healthcare provider or pharmacist before use.

Storage and Handling

The product is supplied in a carton that must remain unopened for safety. It is essential to verify that the seal under the bottle cap, marked with "SEALED for YOUR PROTECTION," is intact before use. If the carton is opened or the seal is broken or missing, the product should not be used.

Storage conditions require the product to be maintained at a temperature range of 20-25ºC (68-77ºF). For optimal integrity, it is advisable to check the end panel for the lot number and expiration date prior to use.

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.

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.