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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
April 29, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
April 29, 2013
Manufacturer
Chain Drug Consortium LLC
Registration number
ANDA091237
NDC root
68016-295
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen Tablets 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 various conditions, including backaches, headaches, menstrual cramps, arthritis, muscular aches, the common cold, and toothaches.

In addition to pain relief, ibuprofen is effective in lowering fever, making it a versatile option for managing discomfort and illness. It is dye-free, which may be preferable for those with sensitivities to certain color additives.

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 relief from these common ailments, making it easier to go about your daily activities without being hindered by discomfort. Always remember to follow the recommended guidelines for use.

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 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, it is important not to use this medication right before or after undergoing heart surgery, as it may pose risks to your health. Always consult with your healthcare provider if you have any concerns or questions about your specific situation.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergy 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 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, contact your doctor. Always consult with a healthcare professional before using ibuprofen if you have any 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 of an allergic reaction may include wheezing, blisters, facial swelling, hives, rash, shock, skin reddening, and more. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication is a nonsteroidal anti-inflammatory drug (NSAID) and may 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. It’s important to monitor for signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. If you notice any of these symptoms, or if your pain or fever worsens or lasts longer than expected, stop using ibuprofen and contact your doctor.

In case of an overdose, seek emergency medical help or contact a Poison Control Center right away. Regular lab tests may be necessary to monitor your health while using this medication, so be sure to follow your doctor's recommendations.

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 cause kidney failure, liver damage, and gastrointestinal bleeding.

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

Pregnancy Use

Before using ibuprofen during pregnancy, it’s crucial to consult with a healthcare professional. This is particularly important in the last three months of pregnancy, as taking 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 breastfeeding or planning to breastfeed, 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 your baby's well-being by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet 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 a doctor advises otherwise. 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 considerations when taking medications. If you are 60 years old 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 the treatment is safe and appropriate for your specific 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 for patients with 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 and what steps to take for your safety.

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 certain medications can interact with each other, which may affect their effectiveness or increase the risk of side effects. For instance, if you take ibuprofen, it may reduce the protective benefits of aspirin when used for heart attack or stroke prevention. Additionally, using other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescribed or over-the-counter, can heighten the risk of adverse effects.

If you are on blood thinners (anticoagulants) or steroid medications, combining them with ibuprofen can increase the risk of stomach bleeding. Always discuss any medications you are taking, including over-the-counter drugs, with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it 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 that the seal under the bottle cap, marked with “SEALED for YOUR PROTECTION,” is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a health 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 200 mg used for?

Ibuprofen Tablets 200 mg are used to temporarily relieve minor aches and pains, such as backache, headache, menstrual cramps, and toothache, as well as to reduce fever.

How should I take Ibuprofen Tablets?

Adults and children 12 years and older 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 contraindications for using Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are using it right before or after heart surgery.

What should I do if I experience an allergic reaction?

If you experience symptoms such as asthma, hives, or facial swelling, stop using Ibuprofen and seek medical help immediately.

What are the warnings associated with Ibuprofen?

Ibuprofen may cause stomach bleeding, especially in individuals over 60, those with stomach ulcers, or those taking blood thinners. Seek medical attention if you experience faintness, vomit blood, or have bloody or black stools.

Can I use Ibuprofen during pregnancy?

Consult a health professional before using Ibuprofen if you are pregnant or breastfeeding, especially during the last 3 months of pregnancy, as it may cause complications.

What should I do if my symptoms do not improve?

If your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days, stop using 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 contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These tablets are dye-free and are available in packages of 100 coated tablets and 50 coated tablets.

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 is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated 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 asthma (wheezing), blisters, facial swelling, hives, rash, shock, skin reddening, and other manifestations. 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 an increased risk of stomach bleeding. The likelihood of experiencing such adverse effects is heightened in patients who meet any of the following criteria: individuals aged 60 years or older, those with a history of severe stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, individuals taking other prescription NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), and those consuming three or more alcoholic beverages daily while using this product. Additionally, prolonged use or exceeding the recommended dosage may further elevate the risk of gastrointestinal complications.

In cases of overdose, immediate medical intervention is necessary. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any of the following symptoms: feeling faint, vomiting blood, or passing bloody or black stools, as these may indicate stomach bleeding; worsening pain that persists beyond 10 days; fever that intensifies or lasts more than 3 days; exacerbation of stomach pain or discomfort; presence of redness or swelling in the affected area; or the emergence of any new symptoms. Regular monitoring and assessment of these parameters are essential to ensure patient safety during treatment.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly allergic reactions and gastrointestinal complications.

Severe allergic reactions may occur, especially in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 risk of stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use the medication for longer than directed. Patients should stop using ibuprofen and consult a healthcare provider if they experience symptoms such as feeling faint, vomiting blood, or noticing bloody or black stools, which may indicate stomach bleeding.

Common adverse reactions may include gastrointestinal discomfort, such as stomach pain or upset, which can worsen or persist. Patients should also be vigilant for any new symptoms, and if pain or fever lasts longer than 10 days or 3 days respectively, they should seek medical advice. Redness or swelling in the painful area should also prompt consultation with a healthcare professional.

Before using ibuprofen, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, ongoing stomach issues, 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 using other NSAIDs, anticoagulants, or steroids, or if they are under treatment for any serious condition, as these factors may influence the safety and efficacy of ibuprofen. It is particularly important for patients taking aspirin for cardiovascular protection to discuss their use of ibuprofen, as it may diminish the intended benefits of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attacks or strokes. Therefore, concurrent use of ibuprofen with aspirin for these indications is not recommended.

The concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, may elevate the risk of adverse effects associated with NSAID therapy. Caution is advised when considering the use of multiple NSAIDs simultaneously.

Additionally, the use of ibuprofen in conjunction with anticoagulants or steroid medications may heighten the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

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

Children under 12 years of age should consult a healthcare professional before use. For adolescents and adults 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 not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of 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 crucial 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 are advised to 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 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 healthcare 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 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, caution is recommended when considering the use of this medication while breastfeeding.

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 population 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 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 lead to serious adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms and management strategies associated with ibuprofen overdosage.

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 necessitate immediate medical evaluation and intervention.

Recommended Actions If an overdose is suspected, it is imperative to seek emergency medical attention without delay. Healthcare providers should conduct a thorough assessment of the patient's condition and consider appropriate diagnostic tests to evaluate organ function and the extent of any potential damage.

Management of ibuprofen overdosage may involve supportive care, monitoring of vital signs, and specific treatments aimed at mitigating the adverse effects. It is essential for healthcare professionals to remain vigilant and act swiftly to address the complications associated with ibuprofen overdosage.

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

Long-term continuous use of the product has been associated with an increased risk of heart attack or stroke, as reported in voluntary postmarketing surveillance programs. These findings reflect the experiences of patients and healthcare providers and are part of ongoing monitoring efforts.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be informed that long-term continuous use of the medication may increase the risk of heart attack or stroke. They should be instructed to stop use and consult a doctor if they experience any of the following symptoms: feeling faint, vomiting blood, or noticing bloody or black stools, as these may indicate stomach bleeding. Additionally, patients should discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, or if their stomach pain or upset intensifies or continues.

Patients should also be advised to stop use and consult a doctor if they observe redness or swelling in the painful area or if any new symptoms arise. It is important for patients to ask 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 they have ongoing stomach issues such as heartburn, upset stomach, or stomach pain.

Furthermore, patients should be encouraged to consult a doctor before use if they have ulcers, bleeding problems, high blood pressure, or a history of heart or kidney disease. Those who have taken a diuretic, are 60 years of age or older, or are under a doctor’s care for any serious condition should also seek medical advice prior to use.

Patients should be reminded to consult a doctor or pharmacist before using the medication if they are taking any other drugs containing NSAIDs, blood thinners (anticoagulants), or steroid medications. It is particularly important for patients taking aspirin for heart attack or stroke prevention to discuss this with their healthcare provider, as ibuprofen may diminish the benefits of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking any other medications.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20-25 °C (68-77 °F). It is essential to ensure that the seal under the bottle cap, which is imprinted with “SEALED for YOUR PROTECTION,” remains intact. If this seal is broken or missing, the product should not be used. Proper adherence to these storage conditions and handling instructions is crucial for maintaining the integrity and safety of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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

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

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