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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2020
Label revision date
January 3, 2024
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 2020
Label revision date
January 3, 2024
Manufacturer
TARGET CORPORATION
Registration number
ANDA091239
NDC root
11673-991
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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, as well as reduce fever. You can use it for various types of discomfort, including headaches, toothaches, backaches, menstrual cramps, and muscular aches. It is also effective for alleviating minor pain associated with arthritis and symptoms of the common cold.

By targeting these specific types of pain, this medication helps you feel more comfortable and can support your overall well-being during times of discomfort.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. It can also help ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to use it as directed to ensure you get the best results.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should never take more than the recommended amount, and it's best to use the smallest dose that effectively relieves your symptoms.

For adults and children aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while your symptoms last. If you find that 1 tablet isn't enough to relieve your pain or fever, you may take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you're considering this medication for a child under 12 years old, it's essential to consult with a doctor first to ensure it's safe and appropriate for them.

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 it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the use of this medication.

Side Effects

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

Additionally, ibuprofen carries risks of stomach bleeding, particularly for individuals over 60, those with a history of stomach ulcers or bleeding, and those taking certain medications like blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for extended periods. If you notice signs of stomach bleeding (such as faintness, vomiting blood, or black stools) or symptoms of heart problems (like chest pain or trouble breathing), contact your doctor right away. Always consult your healthcare provider before using ibuprofen if you have existing health conditions or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. There is also an increased risk of heart attack and stroke with ibuprofen, especially if used in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics or other medications. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems or stroke, such as chest pain or trouble breathing, stop taking ibuprofen and call your doctor. Also, seek medical advice if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, or if you notice any new symptoms.

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 of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, 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 any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always 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 if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before giving them this medication. For children aged 12 and older, the recommended dosage is one tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give two tablets, but be careful not to exceed six tablets in a 24-hour period unless your 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 when taking medications. If you are 60 years or older, you should know that the risk of severe stomach bleeding increases. This is a serious concern, so it's essential to discuss any medications with your healthcare provider.

Additionally, if you have conditions like high blood pressure, heart disease, liver cirrhosis (a liver condition), kidney disease, asthma, or a history of stroke, make sure to consult your doctor before starting any new medication. These health issues can be more common in older adults and may affect how you should use certain drugs safely. Always prioritize your health by seeking professional advice tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can affect your treatment plan. Your safety is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware that taking ibuprofen can affect how aspirin works, especially if you're using aspirin to prevent heart attacks or strokes. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, can increase your risk of stomach bleeding. If you are on blood thinners or steroids, you should be particularly cautious, as these medications can further elevate the risk of bleeding.

Before starting ibuprofen, especially if you have a serious health condition, it's crucial to consult with your healthcare provider. They can help ensure that your medications work safely and effectively together. Always discuss any medications or tests with your doctor to avoid potential interactions and protect your health.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25ºC (68-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your 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 headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop use and seek medical help immediately.

What are the dosage instructions for adults and children over 12?

Take 1 tablet every 4 to 6 hours while symptoms persist, and do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should I do if I have a history of stomach problems?

Ask a doctor before use if you have a history of stomach problems, such as ulcers or bleeding.

Is this drug safe to use during pregnancy?

If you are pregnant or breastfeeding, consult a healthcare professional before use, especially after 20 weeks of pregnancy.

What should I do if I experience signs of stomach bleeding?

Stop use and call your doctor if you feel faint, vomit blood, or have bloody or black stools.

Can I take this drug if I have high blood pressure or heart disease?

You should ask a doctor before use if you have high blood pressure, heart disease, or other serious conditions.

What are the storage conditions for this drug?

Store at 20-25ºC (68-77ºF).

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

SPL code 34089-3 corresponds to a pharmaceutical product available in a quantity of 50 count per package.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The smallest effective dose should be utilized to manage symptoms effectively.

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. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. However, 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 advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to cardiovascular stability during this critical period.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Before initiating treatment with ibuprofen, it is advisable for patients to consult a physician if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice prior to use.

Patients under medical supervision for serious conditions, those taking aspirin for cardiovascular protection, or individuals on other medications should also consult a healthcare provider or pharmacist before using ibuprofen, as it may interfere with the efficacy of aspirin.

In the event of an allergic reaction, immediate cessation of ibuprofen and prompt medical attention are essential.

Patients should discontinue use and contact a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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

The use of ibuprofen carries a significant risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include worsening pain that persists beyond 10 days, fever that worsens or lasts more than three days, and the presence of redness or swelling in the affected area. Patients are encouraged to consult a healthcare professional if any new symptoms arise.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable to seek medical advice if they are under a doctor's care for any serious condition, are taking aspirin for cardiovascular protection, or are using any other medications.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of ibuprofen with other NSAIDs, including both prescription and nonprescription medications such as aspirin and naproxen, is associated with an increased risk of gastrointestinal bleeding. Therefore, it is advised that patients avoid using multiple NSAIDs simultaneously.

Anticoagulants and Steroids Patients who are on anticoagulant therapy or corticosteroids should exercise caution when using ibuprofen, as these combinations elevate the risk of stomach bleeding. Close monitoring for signs of gastrointestinal complications is recommended in these patients.

Aspirin for Cardiovascular Protection Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult with a healthcare professional regarding the timing and use of ibuprofen in relation to aspirin therapy.

General Recommendations The use of ibuprofen is not recommended for individuals under a physician's care for any serious medical condition without prior consultation. It is essential for patients to discuss their medication regimen with a healthcare provider to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Therefore, caution is advised when prescribing this medication to this population.

It is essential for healthcare providers to assess the overall health status of geriatric patients prior to initiating treatment. Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult with their healthcare provider before use, as these conditions may be more prevalent in elderly individuals and could influence the safety and efficacy of the medication.

Close monitoring and appropriate dose adjustments may be necessary to mitigate potential risks associated with treatment 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 ibuprofen in pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of this medication.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details 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, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, severe stomach bleeding has been reported. There is also an increased risk associated with heart attack, heart failure, and stroke.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should 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 is important to instruct patients not to use the medication right before or after heart surgery.

Patients should be made aware of the signs of potential stomach bleeding and instructed to stop use and consult a doctor if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to stop use and seek medical attention if they exhibit symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should also 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 more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is essential to recommend that patients consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn.

Patients should be encouraged to seek medical advice before using this medication if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking a diuretic or under a doctor's care for any serious condition should consult their healthcare provider prior to use.

Finally, patients should be informed to speak with their doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. It is also advisable for patients to consult a healthcare professional before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks 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.

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.