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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
ANDA091237
NDC root
11673-993
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 those caused by headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it helps to reduce fever, providing comfort when you're feeling unwell.

By targeting these common discomforts, this drug can help you feel better and manage your symptoms effectively.

Uses

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

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with just 1 caplet, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after heart surgery, as it could pose serious risks to your health. 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. Symptoms of such reactions may include hives, facial swelling, wheezing, shock, skin reddening, rash, 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 issues, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

Furthermore, using ibuprofen may elevate the chances of heart attack, heart failure, and stroke, which can be life-threatening. This risk is heightened if you exceed the recommended dosage or duration of use. If you experience symptoms such as faintness, vomiting blood, bloody or black stools, chest pain, difficulty breathing, or any new concerning symptoms, it is important to stop using ibuprofen and consult a doctor immediately.

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 the product 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 it for longer than recommended. Additionally, using NSAIDs like ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop taking ibuprofen and call your doctor. Seek immediate medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, contact your doctor 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. In case of an overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

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 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 with a doctor before using this medication. For children aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets. However, be sure not to exceed six caplets in a 24-hour period unless directed by a healthcare professional. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medication use. If you are 60 or older, the risk of severe stomach bleeding increases, so it's crucial to take precautions. Additionally, using more than the recommended dose or taking medication for longer than advised can raise your chances of heart attack, heart failure, and stroke.

To minimize these risks, always aim to use the smallest effective dose and never exceed 6 caplets in a 24-hour period unless your doctor instructs you otherwise. If you experience stomach upset, taking your medication with food or milk can help, especially since older adults may have more sensitive stomachs. Always consult with your healthcare provider to ensure safe and effective use of any medication.

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 have experienced 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 open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe liver scarring), 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 closely to ensure your safety.

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 also affect your treatment plan. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, including over-the-counter options like ibuprofen. For instance, if you are using ibuprofen alongside aspirin for heart health, it may reduce the effectiveness of aspirin in preventing heart attacks or strokes. Additionally, if you are on blood thinners or steroids, combining these with ibuprofen can increase your risk of stomach bleeding.

Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can also raise your chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for longer than recommended. Always consult your healthcare provider to ensure your medications work safely and effectively together.

Storage and Handling

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

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.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with 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 does this drug temporarily relieve?

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

Does this drug reduce fever?

Yes, this drug temporarily reduces fever.

What should adults and children 12 years and older do for dosing?

Adults and children 12 years and older should take 1 caplet every 4 to 6 hours while symptoms persist, and may take 2 caplets if pain or fever does not respond to 1 caplet. Do not exceed 6 caplets in 24 hours unless directed by a doctor.

What should children under 12 years do before using this drug?

Children under 12 years should ask a doctor before use.

What are the contraindications for this drug?

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

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

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better.

What are the warnings associated with this drug?

Warnings include the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke, especially if used more than directed or for longer than directed.

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

If 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 have high blood pressure or heart disease?

Ask a doctor before use if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke.

How should this drug be stored?

Store this drug 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

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "612" on one side and "R" on the other. Each tablet contains 225 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide (red), and iron oxide (yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, 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 aged 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions. Additionally, the product should not be used immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of ibuprofen.

Allergy Alert Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may 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.

Stomach Bleeding Warning As an NSAID, ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Age 60 or older

  • History of stomach ulcers or bleeding disorders

  • Concurrent use of blood-thinning medications (anticoagulants) or steroid drugs

  • Use of other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

  • Consumption of three or more alcoholic beverages daily while using this product

  • Exceeding the recommended dosage or duration of use

Heart Attack and 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 exceed the recommended dosage or duration of treatment.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical attention or contact a Poison Control Center at 1-800-222-1222.

Monitoring and Discontinuation Patients should be advised to stop taking ibuprofen and consult their healthcare provider if they experience any of the following symptoms:

  • 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

  • Worsening pain that persists beyond 10 days

  • Fever that worsens or lasts more than 3 days

  • Redness or swelling in the affected area

  • Any new or unusual symptoms

Healthcare professionals should ensure that patients are adequately informed of these risks and the importance of monitoring their health while using ibuprofen.

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, facial swelling, asthma (wheezing), shock, skin reddening, rash, 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 the potential risk of severe stomach bleeding. This risk is heightened 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

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 use the medication in excess of the recommended dosage or for extended periods.

Patients should discontinue use and consult a healthcare professional if they experience any 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 attention.

Other important considerations include worsening pain that persists beyond 10 days, fever that worsens or lasts more than 3 days, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

Drug Interactions

The use of ibuprofen is associated with several important drug interactions that may impact patient safety and treatment efficacy.

Interactions with Aspirin Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to consider alternative analgesics that do not interfere with aspirin's efficacy in these contexts.

Interactions with Anticoagulants and Steroids Co-administration of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring for signs of bleeding in patients receiving these combinations. Dose adjustments may be necessary based on the individual patient's risk factors.

Cardiovascular Risks with NSAIDs The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of NSAID therapy and consider alternative treatments, especially in patients with pre-existing cardiovascular conditions. Regular monitoring of cardiovascular status may be warranted in these cases.

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 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful monitoring and consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is elevated in geriatric patients who exceed the recommended dosage or duration of treatment. Therefore, it is crucial to adhere strictly to dosing guidelines to mitigate these risks.

For elderly patients who experience stomach upset, it is advisable to take the medication with food or milk, as this may help alleviate gastrointestinal discomfort, which can be more pronounced in this population.

The smallest effective dose should be utilized in geriatric patients to minimize potential adverse effects. Furthermore, it is imperative that elderly patients do not exceed 6 caplets in a 24-hour period unless specifically directed by a healthcare provider, underscoring the importance of careful dosing and monitoring in this age group.

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 gestation 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 while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a healthcare provider, 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 the risks when considering this medication for lactating mothers.

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 disclose any existing conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in this population to assess any potential impact on drug metabolism and overall safety. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 were identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been documented, including manifestations such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, users of other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used beyond the recommended duration or dosage.

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 or contact a Poison Control Center immediately at 1-800-222-1222.

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

When using this product, patients should be counseled 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 experienced problems or serious side effects from taking pain relievers or fever reducers in the past.

Patients should also be advised to seek medical advice before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems, such as heartburn. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a doctor prior to use.

Patients taking a diuretic should be encouraged to ask a doctor before using this medication. It is also essential for patients to consult a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be advised to consult a healthcare professional before using this product.

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 efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's integrity.

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 critical 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.

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

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

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