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Ibuprofen Thompson

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2021
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2021
Label revision date
September 8, 2025
Manufacturer
Thompson Safety
Registration numbers
ANDA075010, ANDA079174
NDC roots
73408-509, 73408-809
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. It is commonly used to temporarily relieve minor aches and pains associated with various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort and illness.

This medication is designed for households without young children and comes in a package containing 200 mg tablets. It is important to use ibuprofen as directed to ensure its effectiveness and safety.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even pain associated with the common cold or minor arthritis. 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

When using this medication, it's important to follow the instructions carefully. You should only take the amount directed and aim for the smallest effective dose. Generally, you should not use this medication for more than 10 days unless your doctor advises otherwise.

For adults and children aged 12 years and older, the typical dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor tells you to do so. If you are considering giving this medication to a child under 12 years old, it's best to consult with a doctor first.

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 heart surgery, as it may pose risks to your health in these situations. Always consult with your healthcare provider if you have any concerns or questions about your specific circumstances.

Side Effects

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

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

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters. If you experience any of these symptoms, stop using ibuprofen 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 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.

You should stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (such as feeling faint, vomiting blood, or having black stools), experience symptoms of heart problems or stroke (like chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected. In case of an overdose, seek emergency medical help or contact a Poison Control Center right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using 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 your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets, but be careful not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

Geriatric Use

As you age, it's important to be aware of certain risks when using medications like NSAIDs (nonsteroidal anti-inflammatory drugs). If you are 60 or older, you have a higher chance of experiencing severe stomach bleeding, especially if you exceed the recommended dosage or duration of use. This sensitivity means you should always follow the dosage guidelines closely and consult your doctor if you have a history of stomach ulcers or bleeding problems, or if you are taking blood thinners or steroids.

Additionally, older adults may have reduced kidney function, which can affect how your body processes medications like ibuprofen. This may require adjustments to your dosage. Always talk to your healthcare provider about your specific needs and any concerns you may have regarding your medications. Your safety and well-being are the top priority.

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 discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to avoid exposing it to excessive heat, which can occur at temperatures above 104°F (40°C).

When handling the product, make sure to use only tamper-evident sealed packets. If you notice any packets that are opened or torn, do not use them, as this could compromise the safety and effectiveness of the product. Following these guidelines will help you maintain the integrity of the product and ensure safe usage.

Additional Information

No further information is available.

FAQ

What is Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, common colds, muscular aches, and minor arthritis pain.

What is the recommended dosage for adults and children 12 years and older?

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, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke. Consult a doctor if you experience symptoms like chest pain, trouble breathing, or signs of stomach bleeding.

Can I use Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, 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 seek medical help immediately if you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Who should not use 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.

How should I take Ibuprofen to avoid stomach upset?

If you experience stomach upset, take Ibuprofen with food or milk.

What is the storage recommendation for Ibuprofen?

Store Ibuprofen at 68-77°F (20-25°C) and avoid excessive heat above 104°F (40°C).

Packaging Info

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

Packaging configurations for Ibuprofen Thompson.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, and minor arthritis pain. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The medication should be administered according to the following guidelines to ensure safety and efficacy.

For adults and children 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 taken. However, it is imperative that the total 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 advised to consult a doctor for appropriate dosing recommendations.

It is essential to use the smallest effective dose and to refrain from using the medication for longer than 10 days unless specifically instructed by a physician.

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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

  • Are taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, naproxen)

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Heart Attack or Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding:

  • Feeling faint

  • Vomiting blood

  • Presence of bloody or black stools

  • Persistent stomach pain

Additionally, patients should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, including:

  • Chest pain

  • Difficulty breathing

  • Weakness on one side of the body

  • Slurred speech

  • Swelling in the legs

Patients should also be instructed to stop use and consult a healthcare provider if:

  • Pain worsens or persists beyond 10 days

  • Fever worsens or lasts longer than 3 days

  • Redness or swelling occurs in the affected area

  • Any new or unexpected symptoms arise

Emergency Medical Help In cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients who are aged 60 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 use other NSAIDs concurrently.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use.

Patients should discontinue use and seek medical attention if they experience 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 consultation. Furthermore, patients should 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 painful area, or if any new or unexpected symptoms arise.

Before using this product, patients should consult a healthcare professional 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 taking a diuretic or if under a doctor's care for any serious condition. Patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should consult a healthcare provider before use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Ibuprofen Thompson.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within 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 for severe stomach bleeding when using this medication. It is crucial for healthcare providers to advise geriatric patients not to exceed the recommended dosage or duration of use, as they may exhibit heightened sensitivity to the side effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs).

Additionally, there is an elevated risk of heart attack or stroke in elderly patients when NSAIDs are used beyond the recommended guidelines or for extended periods. This risk necessitates careful consideration and monitoring in this population.

Before initiating treatment, it is advisable for healthcare providers to consult with elderly patients who have a history of stomach ulcers or bleeding problems, or who are concurrently taking blood thinners or steroids. Such conditions may further complicate the safety profile of NSAID use in geriatric patients.

Furthermore, it is important to recognize that elderly patients may experience reduced kidney function, which can impact the metabolism and excretion of ibuprofen. Consequently, dosage adjustments may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding 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. 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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against any risks when considering the use of this medication in lactating mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and perform a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Healthcare providers should instruct patients to stop using the medication and consult a doctor if they experience 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. Patients should also be advised to seek medical attention if they exhibit symptoms 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.

Patients should be counseled to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, if there is redness or swelling in the painful area, or if any new or unexpected symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be encouraged to seek medical advice before using this medication. Furthermore, patients taking a diuretic or those under a doctor’s care for any serious condition should consult their healthcare provider prior to use.

Lastly, patients should be advised to speak with a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. It is also recommended that patients consult a healthcare professional before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 104°F (40°C). Opened or torn packets should not be used to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ibuprofen Thompson, 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 Thompson, 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.