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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, Film 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
December 30, 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, Film 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
December 30, 2024
Manufacturer
Spirit Pharmaceutical LLC
Registration number
ANDA079174
NDC root
68210-8100
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen is a medication that belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is commonly used as a pain reliever and fever reducer. You can take ibuprofen to temporarily relieve minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, it helps to lower fever.

Available in 200 mg tablets, ibuprofen works by reducing inflammation and blocking pain signals in the body, making it effective for various everyday discomforts. If you're looking for relief from these types of pain or a way to reduce fever, ibuprofen may be a suitable option for you.

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 note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are considering this medication for a child under 12 years old, it's essential to consult a doctor first to ensure it's safe and appropriate for them. Additionally, you should not take this medication for more than 10 days unless directed by a healthcare professional. Always prioritize your health and safety by following these guidelines.

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 risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

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 (asthma), 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, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. If your pain worsens or lasts more than 10 days, or if you develop new symptoms, seek medical advice. It's important to talk to your doctor before using ibuprofen if you have any existing health conditions, are taking other medications, or have experienced serious side effects from pain relievers in the past.

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, ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use it for longer than recommended. It can also increase the risk of heart attack, heart failure, and stroke, especially with prolonged use.

Before using ibuprofen, consult your doctor if you have had allergic reactions to pain relievers, are scheduled for heart surgery, or have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop taking ibuprofen and contact your doctor. Also, seek emergency help if you suspect an overdose by calling a Poison Control Center 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

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 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 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets 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 that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications that can affect the stomach.

Always consult with your healthcare provider about any medications you are taking, especially if you are older, to ensure they are safe and appropriate for your needs. Your doctor can help you understand the risks and may suggest alternative treatments or additional monitoring to keep you safe.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, or asthma, as these can affect how the medication works for you.

Always prioritize your health by discussing your kidney condition with your doctor to ensure safe and effective treatment.

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. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, kidney disease, or asthma, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, you could face a higher risk of stomach bleeding.

Using ibuprofen for longer than recommended or in higher doses can also increase your risk of heart attack or stroke. Always consult with your healthcare provider or pharmacist before starting any new medication, especially if you are already taking other drugs. This ensures your safety and helps you get the most benefit from your treatments.

Storage and Handling

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

When handling the product, always maintain a clean environment to prevent contamination. If there are any specific components included with your product, make sure to follow any additional instructions provided for their use and safety. Proper storage and careful handling will help you get the most out of your product.

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 during the last three months 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 Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

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

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke, especially if used more than directed or for longer than directed.

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

Stop using Ibuprofen and seek medical help if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use Ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have had an allergic reaction to pain relievers before?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer.

How should I store Ibuprofen?

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

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

Ibuprofen is the active ingredient in Ibuprofen Tablets USP, formulated at a strength of 200 mg. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The tablets are designed for oral administration and are comparable to the active ingredient found in Advil® Tablets.

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, this drug 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, and the duration of use should not exceed 10 days unless otherwise directed by a healthcare professional.

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 maximum of 2 tablets may be administered. However, the total daily dosage must not exceed 6 tablets within a 24-hour period unless specifically instructed by a physician.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with 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 due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause a severe allergic reaction, particularly in individuals with a known allergy to aspirin. Symptoms of such a reaction 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 the 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. Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with prolonged or excessive use.

General precautions should be observed. Ibuprofen should not be used by individuals who have previously experienced an allergic reaction to any other pain reliever or fever reducer. It is also contraindicated for use immediately before or after heart surgery. Healthcare professionals should be consulted prior to use if the patient has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, suffers from stomach issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or is taking a diuretic. Furthermore, patients under a physician's care for any serious condition or those taking aspirin for cardiovascular protection should seek advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should discontinue use and consult a physician if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if stomach discomfort increases or continues, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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.

There is a significant risk of severe stomach bleeding associated with ibuprofen use, especially in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, or are concurrently taking anticoagulants or steroid medications. The risk is further heightened in individuals who consume three or more alcoholic drinks daily while using this product or who exceed the recommended dosage or duration of use.

Additionally, the use of NSAIDs, including ibuprofen, has been linked to 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 guidelines.

Patients are advised to 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. Other concerning symptoms that warrant medical attention include worsening pain lasting more than 10 days, fever lasting more than 3 days, worsening stomach pain or upset, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, suffer from stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare provider if the patient is under medical care for any serious condition or is taking aspirin for heart attack or stroke prevention, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

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 prior to using ibuprofen concurrently with aspirin to ensure optimal therapeutic outcomes.

The concomitant use of anticoagulants or steroid medications with ibuprofen significantly elevates the risk of gastrointestinal bleeding. Patients on these medications should be closely monitored for signs of bleeding and may require dosage adjustments or alternative therapies.

Additionally, exceeding the recommended dosage or duration of ibuprofen therapy may heighten the risk of cardiovascular events, such as heart attack or stroke. It is essential for patients to adhere strictly to dosing guidelines and to seek medical advice if there is a need for prolonged use.

Patients are encouraged to consult with a healthcare provider or pharmacist before initiating ibuprofen therapy, especially if they are currently taking other medications, to mitigate potential interactions and ensure safe use.

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 within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 specifically 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 while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy 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, caution is recommended when considering its use in 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, or asthma, as these may influence the management of therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

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 to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this population. 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 support 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 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 details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have documented gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported.

Additionally, there have been cases of cardiovascular events, such as myocardial infarction and stroke. Reports of allergic reactions, including anaphylaxis and angioedema, have been received. Instances of elevated blood pressure in patients taking ibuprofen have been noted, along with occurrences of dizziness and headache in some users.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed not to use 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical advice if their pain worsens or lasts longer than 10 days, if their fever worsens or lasts more than 3 days, or if they experience worsening stomach pain or upset. Any redness or swelling in the painful area, as well as the appearance of new symptoms, should prompt a consultation with a healthcare provider.

When using this product, patients should be encouraged to take it with food or milk if they experience stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for an extended period.

Patients should be advised to consult a doctor before use if they have a history of stomach bleeding or if they have experienced serious side effects from pain relievers or fever reducers. They should also seek medical advice if they have stomach issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients taking diuretics or under a doctor's care for any serious condition should consult their healthcare provider before use.

Lastly, patients should be informed to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. It is also advisable to consult a healthcare professional before using this medication in conjunction with 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 temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last three months 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.