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Probufen

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This product has been discontinued

Active ingredient
Ibuprofen 400 mg/537 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
September 4, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 400 mg/537 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
September 4, 2012
Manufacturer
SAMSUNG PHARM IND. CO. , LTD.
Registration number
part343
NDC root
49789-050
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is commonly used to relieve fever and pain associated with various conditions, including rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (a type of joint disease), the common cold, back pain, menstrual cramps (dysmenorrhea), and post-operative pain. It can also be effective for headaches, toothaches, muscle pain (myalgia), nerve pain (neuralgia), acute gout, psoriatic arthritis, and injuries to soft tissues, such as sprains and contusions.

The drug works by targeting inflammation and pain in the body, helping to improve your comfort and mobility. If you're dealing with any of these conditions, this medication may be a suitable option to consider for managing your symptoms.

Uses

You may use this medication to help relieve fever and pain associated with various conditions. These include rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (a type of joint disease), common cold, back pain, menstrual cramps (dysmenorrhea), and pain after surgery.

Additionally, it can be effective for other issues such as ankylosing spondylitis (a type of arthritis affecting the spine), headaches, toothaches, muscle pain (myalgia), nerve pain (neuralgia), acute gout, psoriatic arthritis, soft tissue injuries like sprains and contusions, and non-articular rheumatism (which includes conditions like tendinitis and synovitis).

Dosage and Administration

If you are taking this medication for conditions like rheumatoid arthritis, osteoarthritis, or acute gout, you will typically take between 200 to 600 mg orally, three to four times a day. However, make sure not to exceed a total of 3200 mg in one day. For children with juvenile rheumatoid arthritis, the dosage is based on their weight, usually around 30 to 40 mg for every kilogram, divided into three to four doses throughout the day.

For mild to moderate pain or symptoms of a common cold, adults can take 200 to 400 mg orally, also three to four times a day. You may need to adjust the dosage based on your age or the severity of your symptoms. If you are giving this medication to children, be mindful of their weight. Children under 30 kg should not take more than 500 mg per day, and the specific dosages vary by age group. It's important to take this medication with food, as taking it on an empty stomach is not recommended.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely. Always consult with your healthcare provider if you have any concerns or questions about your treatment.

Side Effects

You should be aware of some potential side effects associated with this medication. There is a risk of gastrointestinal bleeding, especially if you consume more than three glasses of alcohol daily or take other pain-relieving medications. Additionally, using this drug, which is a type of non-steroidal anti-inflammatory drug (NSAID), may increase the chances of serious cardiovascular events, such as heart attacks and strokes, particularly if you have a history of heart problems.

It's also important to note that severe gastrointestinal issues can occur unexpectedly while taking this medication, with the risk being higher for older adults or those using it for an extended period. Always monitor for any unusual symptoms and discuss any concerns with your healthcare provider.

Warnings and Precautions

If you regularly drink more than three glasses of alcohol each day and are considering taking this medication or other pain relievers, it’s important to consult with your doctor or pharmacist first. Doing so can help prevent serious issues like gastrointestinal bleeding, which can occur with this drug.

Be aware that using this medication, which is a type of non-steroidal anti-inflammatory drug (NSAID), may increase your risk of severe cardiovascular problems, such as heart attacks and strokes. This risk is particularly higher for those with existing heart conditions. Additionally, NSAIDs can lead to serious gastrointestinal issues that may arise without warning, especially in older adults or those who have been using the medication for a long time. Always monitor for any unusual symptoms and discuss any concerns with your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

Using ibuprofen during pregnancy is not recommended, particularly in the third trimester, as it may pose risks to your developing baby. There is a potential for fetal harm associated with this medication, so it’s important to be cautious.

If you are pregnant or planning to become pregnant, you should always consult your healthcare provider before taking ibuprofen or any other medication. They can help you understand the risks and suggest safer alternatives if needed.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare provider before using this medication. There is a possibility that the medication can pass into your breast milk, which may pose risks to your nursing infant. Therefore, caution is recommended when considering this drug while nursing. Always prioritize your health and your baby's safety by seeking professional advice.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their age and weight. Children should take the medication 3 to 4 times a day by mouth. For those weighing less than 30 kg (about 66 pounds), the total daily dose should not exceed 500 mg.

Here are the specific unit-doses for different age groups:

  • For children aged 11 to 14 years, the dose is 200 to 250 mg.

  • For those aged 7 to 10 years, the dose is 150 to 200 mg.

  • For children aged 3 to 6 years, the dose is 100 to 150 mg.

  • For toddlers aged 1 to 2 years, the dose is 50 to 100 mg.

Always ensure you adhere to these guidelines to keep your child safe and healthy.

Geriatric Use

As you age, it's important to be aware that the risk of gastrointestinal issues, such as stomach pain or bleeding, can increase. This is especially true if you have been taking this medication for an extended period. If you or a loved one is an older adult, it's crucial to monitor any changes in your health and discuss them with your healthcare provider. They can help ensure that you are using the medication safely and effectively, taking into account your age and any other health conditions you may have.

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 talk to your healthcare provider if you regularly consume more than three glasses of alcohol a day and are considering taking this medication or other pain relievers. Doing so could increase your risk of gastrointestinal bleeding. Additionally, using this medication along with non-steroidal anti-inflammatory drugs (NSAIDs) can lead to serious heart-related issues, such as heart attacks and strokes, especially in those with existing heart conditions.

Be aware that NSAIDs can also cause severe stomach problems that might not show any warning signs, particularly in older adults or those who have been using the medication for a long time. Always discuss your current medications and any potential risks with your doctor to ensure your safety.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a hermetic container, which is a sealed container that prevents air and moisture from entering. Keep the temperature between 1°C to 30°C (34°F to 86°F) to maintain its quality.

When handling the product, always ensure that you are in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you regularly consume more than three glasses of alcohol each day and plan to use this drug or other pain relievers (antipyretics and analgesics), it’s important to consult with your doctor or pharmacist first. This is because there is a risk of gastrointestinal bleeding (bleeding in the stomach or intestines) when combining alcohol with this medication.

FAQ

What conditions can this drug be used for?

This drug can be used for fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, common cold, back pain, dysmenorrhea, and post-operative pain, among others.

What is the recommended dosage for adults?

For adults, the dosage is typically 200-600 mg taken orally, 3-4 times a day, with a maximum of 3200 mg per day.

What is the dosage for children?

Children weighing less than 30 kg should not exceed 500 mg per day, with specific dosages based on age ranging from 50 mg to 250 mg.

Are there any warnings associated with this drug?

Yes, there are warnings about gastrointestinal bleeding, cardiovascular risks, and severe gastrointestinal adverse reactions, especially in elderly patients or those taking the drug for a long time.

Is this drug safe to use during pregnancy?

The use of this drug during pregnancy is contraindicated, especially in the third trimester, due to potential risks to the fetus.

Can nursing mothers use this drug?

Nursing mothers should consult a healthcare provider before using this medication, as there is a potential for excretion in breast milk.

What should you do if you regularly consume alcohol?

If you regularly consume more than three glasses of alcohol daily, consult a doctor or pharmacist before taking this drug, as it may increase the risk of gastrointestinal bleeding.

How should this drug be stored?

Store this drug in a hermetic container between 1°C to 30°C.

Packaging Info

Below are the non-prescription pack sizes of Probufen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Probufen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the management of fever and pain associated with various conditions, including rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain.

Additionally, this drug is utilized in the treatment of the following diseases: ankylosing spondylitis, headache, toothache, myalgia, neuralgia, acute gout, psoriatic arthritis, soft tissue injuries (such as sprains and contusions), and non-articular rheumatism (including tendinitis, tenosynovitis, and synovitis).

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, and psoriatic arthritis, the recommended dosage for adults is 200 to 600 mg taken orally, 3 to 4 times daily. The maximum allowable dosage should not exceed 3200 mg per day.

In cases of juvenile rheumatoid arthritis, the dosage is calculated based on body weight, with a recommended range of 30 to 40 mg per kg, divided into 3 to 4 portions taken orally each day.

For the management of mild to moderate pain and symptoms associated with the common cold, adults may take 200 to 400 mg orally, 3 to 4 times daily. Dosage adjustments may be necessary based on the patient's age or specific symptoms.

For pediatric patients, the following unit-doses are recommended for administration 3 to 4 times daily:

  • Children weighing less than 30 kg should not exceed a total daily dosage of 500 mg.

  • For children aged 11 to 14 years, the dosage is 200 to 250 mg.

  • For children aged 7 to 10 years, the dosage is 150 to 200 mg.

  • For children aged 3 to 6 years, the dosage is 100 to 150 mg.

  • For children aged 1 to 2 years, the dosage is 50 to 100 mg.

It is advisable to administer the medication with food to avoid gastrointestinal discomfort, and it is recommended to avoid administration on an empty stomach.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients who consume more than three alcoholic beverages daily should consult a healthcare professional before using this medication or any other antipyretic and analgesic. The concomitant use of alcohol and this drug may increase the risk of gastrointestinal bleeding.

The administration of non-steroidal anti-inflammatory drugs (NSAIDs), including this product, is associated with significant cardiovascular risks. These may include severe cardiovascular thrombotic events, myocardial infarction, and stroke. The likelihood of experiencing abnormal cardiovascular reactions is heightened in patients with pre-existing conditions. Therefore, it is imperative that healthcare providers closely monitor patients for any adverse cardiovascular reactions during treatment.

Additionally, the use of NSAIDs can lead to serious gastrointestinal adverse reactions, which may occur unexpectedly during the treatment period. The risk of such reactions is particularly elevated in elderly patients and those who have been on this medication for extended durations. Healthcare professionals should remain vigilant for signs of gastrointestinal complications in these populations.

In summary, careful consideration and monitoring are essential when prescribing this medication, especially for patients with a history of alcohol use, cardiovascular issues, or those who are elderly or on long-term NSAID therapy.

Side Effects

Patients receiving this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include gastrointestinal bleeding, which may occur in individuals who regularly consume more than three glasses of alcohol daily while taking this drug or other antipyretic and analgesic medications. Additionally, the administration of non-steroidal anti-inflammatory drugs (NSAIDs), including this product, is associated with significant cardiovascular risks. These risks encompass severe cardiovascular thrombotic events, myocardial infarction, and stroke. Patients with a history of cardiovascular issues are at an increased risk for abnormal cardiovascular reactions, necessitating careful monitoring during treatment.

Common adverse reactions may involve gastrointestinal complications. The use of NSAIDs, including this product, can lead to severe gastrointestinal adverse reactions that may develop without warning during the administration period. The likelihood of these reactions is heightened in elderly patients or those who have been on this medication for an extended duration.

Healthcare providers should remain vigilant for these potential adverse reactions and assess the risk factors in patients prior to and during treatment.

Drug Interactions

Patients who consume alcohol in excess of three glasses daily should consult a healthcare professional before using this drug or any other antipyretic or analgesic. The combination may increase the risk of gastrointestinal bleeding.

Non-steroidal anti-inflammatory drugs (NSAIDs), including this product, are associated with an elevated risk of severe cardiovascular thrombotic events, such as myocardial infarction and stroke. This risk is particularly heightened in patients with pre-existing cardiovascular conditions. Continuous monitoring for adverse cardiovascular reactions is advised during treatment.

Additionally, the use of NSAIDs, including this product, may lead to serious gastrointestinal adverse reactions, which can occur without prior warning. The likelihood of these adverse effects is increased in elderly patients and those who have been on this medication for an extended duration. Close observation for gastrointestinal symptoms is recommended in these populations.

No specific information regarding interactions between this drug and laboratory tests is available.

Packaging & NDC

Below are the non-prescription pack sizes of Probufen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Probufen.
Details

Pediatric Use

Pediatric patients should receive the unit-dose orally, 3 to 4 times a day. For children weighing less than 30 kg, the total daily dosage should not exceed 500 mg.

The recommended unit-doses for specific age groups are as follows:

  • For children aged 11 to 14 years, the dosage is 200 to 250 mg.

  • For children aged 7 to 10 years, the dosage is 150 to 200 mg.

  • For children aged 3 to 6 years, the dosage is 100 to 150 mg.

  • For infants aged 1 to 2 years, the dosage is 50 to 100 mg.

Healthcare professionals should ensure adherence to these dosing guidelines to optimize safety and efficacy in pediatric patients.

Geriatric Use

Elderly patients may experience an increased risk of gastrointestinal adverse reactions, particularly those who are 65 years of age and older or those who have been on this medication for an extended duration. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Due to the heightened risk associated with this demographic, careful consideration should be given to the dosage and duration of therapy in geriatric patients. Regular assessment of the patient's overall health status and medication regimen is recommended to mitigate potential adverse effects.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. There is a potential risk of fetal harm associated with the use of ibuprofen during pregnancy. Pregnant patients are advised to consult a healthcare provider prior to using this medication to discuss potential risks and alternative treatment options.

Lactation

Lactating mothers should consult a healthcare provider before using this medication. There is a potential for excretion in breast milk, and caution is advised when administering this drug to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no observed increase in fetal malformations, indicating a lack of non-teratogenic effects.

The nonclinical toxicology section does not provide further details regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the drug. These include gastrointestinal bleeding, cardiovascular thrombotic events, myocardial infarction, and stroke.

Additionally, it has been noted that the risk of severe gastrointestinal adverse reactions may develop without warning signs during the administration period. This risk appears to be particularly pronounced in elderly patients or those who have been on the medication for an extended duration.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

Storage and Handling

The product is supplied in hermetic containers to ensure optimal preservation. It should be stored at temperatures ranging from 1°C to 30°C to maintain its efficacy and stability. Proper storage conditions are essential for the integrity of the product.

Additional Clinical Information

The drug is administered orally. Clinicians should advise patients who consume more than three alcoholic beverages daily to consult a healthcare professional before using this medication or any other antipyretic and analgesic, as there is a risk of gastrointestinal bleeding associated with its use in this population. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Probufen, 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 Probufen, 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.