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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1987
Label revision date
November 30, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 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 1987
Label revision date
November 30, 2019
Manufacturer
HART Health
Registration number
part343
NDC root
50332-0118
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 designed to temporarily relieve minor aches and pains, such as headaches, muscular aches, backaches, toothaches, menstrual cramps, and minor arthritis pain. Additionally, it helps to reduce fever, making it a useful option when you're feeling unwell.

By targeting these common discomforts, this medication can provide you with some relief, allowing you to feel more comfortable during times of pain or illness.

Uses

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

This medication is designed to provide you with quick relief from these common ailments, making it easier to go about your daily activities without being hindered by pain or fever.

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 to relieve your symptoms. If you find that 1 tablet isn’t enough to manage 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 of age, it’s best to consult a doctor before giving them this medication. Remember to take the tablets by mouth, and only use them as often as needed to help with your symptoms.

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 this could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your eligibility to use this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If you experience symptoms such as hives, rash, facial swelling, or difficulty breathing (asthma), seek medical help immediately. Additionally, ibuprofen is associated with an increased risk of stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or steroids.

It's important to stop using ibuprofen and consult a doctor if you notice any signs of an allergic reaction, if your fever worsens or lasts more than three days, or if your pain persists beyond ten days. Be cautious and talk to your doctor if you have a history of stomach issues, high blood pressure, or are taking other medications, as these factors can increase your risk of complications.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Signs of an allergic reaction may include hives, rash, facial swelling, asthma (wheezing), and skin reddening. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that can lead to stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or take certain medications like blood thinners or steroids. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

If you experience any allergic reactions, worsening fever lasting more than three days, worsening pain lasting more than ten days, or signs of stomach bleeding (such as feeling faint, vomiting blood, or having black stools), you should stop using ibuprofen and contact your doctor immediately. In case of an overdose, seek emergency medical help or call a Poison Control Center at 1-800-222-1222. There are no specific lab tests required for the safe use of this medication.

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 signs or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any concerning symptoms, seek medical help right away. It's always better to err on the side of caution when it comes to your health. If you are ever in doubt, contact your healthcare provider or local emergency services for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, 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.

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 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 the health of your baby by seeking professional advice.

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, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets, but be sure 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 risks associated with medications. If you are 60 or older, the risk of stomach bleeding increases, so it's crucial to monitor any unusual symptoms and discuss them with your healthcare provider. Additionally, if you have conditions like high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or kidney disease, you should consult your doctor before starting any new medication.

Long-term use of some medications may also raise the risk of serious issues like heart attacks or strokes, which can be particularly concerning for older adults. Always keep an open line of communication with your healthcare team to ensure that your treatment plan is safe and effective for your specific health needs.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and affect your health. For instance, if you take ibuprofen along with aspirin for heart protection, it may reduce the effectiveness of aspirin. Additionally, using ibuprofen with blood thinners (medications that prevent blood clots) or steroids can increase your risk of stomach bleeding. Long-term use of ibuprofen may also raise your chances of having a heart attack or stroke, especially if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

To ensure your safety, always discuss any medications you are taking with your healthcare provider. They can help you understand the risks and benefits, and make sure that your treatment plan is safe and effective for you.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You should take this medication as follows: Adults and children aged 12 and over can take 1 tablet every 4 to 6 hours while symptoms persist. If one tablet does not relieve pain or fever, you may take 2 tablets, but do not exceed 6 tablets in a 24-hour period unless directed by a doctor. For children under 12, consult a doctor for appropriate dosing.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Avoid using ibuprofen during the last three months of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

FAQ

What is the general use of this drug?

This drug temporarily relieves minor aches and pains and reduces fever.

What types of pain does this drug relieve?

It relieves minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, toothache, menstrual cramps, and the common cold.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years of age and over should take 1 tablet every 4 to 6 hours while symptoms persist, not exceeding 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, seek medical help right away.

Are there any warnings regarding stomach bleeding?

Yes, this drug may cause stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or take blood thinners.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially during the last 3 months of pregnancy.

What should I do if my symptoms do not improve?

If fever lasts more than 3 days or pain lasts more than 10 days, consult a doctor.

What are the storage instructions for this drug?

Store at room temperature, protect from light, and keep out of reach of children.

What should I do if I overdose?

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

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

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor arthritis pain, common pain, toothache, 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 12 years of age and older are advised to take 1 tablet orally 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 no more than 6 tablets are taken within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to 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, rash, shock, facial swelling, asthma (wheezing), skin reddening, and blisters. It is imperative that patients are monitored for these symptoms, and immediate medical attention should be sought if any occur.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of stomach bleeding. The likelihood of this adverse effect increases under certain conditions, including but not limited to:

  • Patients aged 60 years or older

  • A history of stomach ulcers or bleeding disorders

  • Use of ibuprofen beyond the recommended duration or dosage

  • Concurrent use of anticoagulants or steroid medications

  • Consumption of three or more alcoholic beverages daily while using ibuprofen

  • Co-administration with other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, naproxen)

Healthcare providers should counsel patients on these risks and consider alternative therapies for those at higher risk.

Monitoring and Discontinuation Patients should be advised to discontinue ibuprofen and consult a healthcare professional if any of the following occur:

  • Signs of an allergic reaction

  • Worsening fever lasting more than three days

  • Worsening pain lasting more than ten days

  • Presence of redness or swelling in the affected area

  • Emergence of new symptoms

  • Indicators of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Laboratory Tests Currently, there are no specific laboratory tests recommended for the safe use of ibuprofen. However, healthcare professionals should remain vigilant and assess patient history and concurrent medications to mitigate risks associated with its use.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, rash, shock, facial swelling, asthma (wheezing), skin reddening, and blisters. In the event of an allergic reaction, patients are advised to seek medical assistance immediately.

The use of ibuprofen carries a warning regarding the risk of stomach bleeding, which is heightened in certain populations. Patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking blood thinners (anticoagulants) or steroid medications are at increased risk. Additionally, prolonged use beyond the recommended duration, excessive alcohol consumption (three or more drinks daily), and concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen) can further elevate this risk.

Patients should discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction, if fever worsens or persists beyond three days, if pain intensifies or lasts more than ten days, if redness or swelling occurs in the affected area, if new symptoms arise, or if they exhibit any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if they are taking diuretics, other NSAIDs, or blood thinners, or if they are under a physician's care for any serious medical condition.

Drug Interactions

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

Pharmacodynamic Interactions

When ibuprofen is taken concurrently with aspirin, particularly for cardiovascular protection against heart attack or stroke, it may diminish the cardioprotective effects of aspirin. This interaction is critical for patients relying on aspirin for these indications.

The concomitant use of ibuprofen with anticoagulants or steroid medications can elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

Pharmacokinetic Interactions

Long-term continuous use of ibuprofen has been associated with an increased risk of cardiovascular events, including heart attack and stroke. This risk is particularly pertinent for patients with pre-existing cardiovascular conditions or those on other medications that may exacerbate this risk.

Additionally, the likelihood of gastrointestinal bleeding is heightened when ibuprofen is used alongside other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen, or other prescription and non-prescription NSAIDs. It is advisable to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

In summary, healthcare providers should exercise caution when prescribing ibuprofen in conjunction with these medications and consider appropriate dosage adjustments or enhanced monitoring for patients at 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

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 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 stomach bleeding. Therefore, caution is advised when prescribing this medication to this population.

It is essential for healthcare providers to inquire about the presence of comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease before initiating treatment in geriatric patients. These conditions may exacerbate potential risks associated with the medication.

Additionally, long-term continuous use of this medication may elevate the risk of heart attack or stroke, which is particularly concerning for elderly patients. Regular monitoring and assessment of cardiovascular health are recommended for this demographic to mitigate potential adverse effects.

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 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.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available 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

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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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.

Healthcare providers should monitor patients 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 overdosage, it is recommended that healthcare professionals initiate supportive care, which may include the following steps:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the situation.

It is essential for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdosage scenario, even in the absence of detailed information.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, rash, shock, facial swelling, asthma (wheezing), skin reddening, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals who exceed the recommended dosage, those taking blood thinners or steroids, consumers of three or more alcoholic drinks daily while using the product, and those using other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, long-term continuous use of the product may be associated with an increased risk of heart attack or stroke.

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 be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Patients should be informed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, if their fever worsens or persists for more than three days, or if their pain intensifies or lasts longer than ten days. They should also seek medical advice if they notice redness or swelling in the painful area, if new symptoms arise, or if they exhibit any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

When using this product, patients should take it with food or milk if they experience stomach upset. It is important to communicate that long-term continuous use may increase the risk of heart attack or stroke.

Patients should be encouraged to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. They should also seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are taking any other drug containing a nonsteroidal anti-inflammatory drug (NSAID), a blood-thinning (anticoagulant) or steroid drug, or if they take aspirin for heart attack or stroke, as ibuprofen may reduce the benefits of aspirin. Lastly, patients under a doctor's care for any serious condition should also seek guidance before using this medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not respond to 1 tablet, 2 tablets may be taken; however, the total dosage should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a doctor, 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.

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.