Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Pain Relief Ibuprofen

Last content change checked dailysee data sync status

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 2002
Label revision date
February 2, 2026
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 2002
Label revision date
February 2, 2026
Manufacturer
Rite Aid Corporation
Registration number
ANDA075139
NDC root
11822-0392
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that is commonly used to relieve pain and reduce fever. It comes in 200 mg tablets and is effective for temporarily alleviating minor aches and pains associated with various conditions, including menstrual cramps, toothaches, headaches, backaches, muscular aches, and minor arthritis pain. Additionally, ibuprofen can help lower fever, making it a versatile option for managing discomfort and illness.

Uses

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

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to feel better and get back to your daily activities.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dose 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. 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 determine the appropriate dosage. Always prioritize safety and follow these guidelines to manage your symptoms effectively.

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 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. Additionally, this medication carries a risk of severe stomach bleeding, especially if you take it for longer than recommended, are over 60 years old, or consume alcohol regularly. It’s important to be aware that using ibuprofen can also increase the risk of heart attack and stroke, which can be life-threatening.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or slurred speech. Always talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, or other serious health conditions. Avoid using ibuprofen if you have had an allergic reaction to pain relievers or if you are about to undergo heart surgery.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include skin redness, wheezing, rash, facial swelling, shock, blisters, or hives. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you take it for longer than recommended, are over 60, consume alcohol regularly, or have a history of stomach ulcers or bleeding problems. It’s important to be aware that using ibuprofen may also increase your risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking other medications, especially blood thinners or diuretics. If you experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop taking ibuprofen and call your doctor. Seek immediate medical attention if you notice symptoms of heart problems or stroke, such as chest pain, slurred speech, or difficulty breathing. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, contact your healthcare provider.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and well-being by reaching out for professional assistance in these situations.

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 ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't effective for pain or fever, you may give 2 tablets instead. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize your child's safety and follow these guidelines closely.

Geriatric Use

As you age, it's important to be aware of certain health considerations when taking medications. If you are 60 years or older, there is a higher risk of severe stomach bleeding. To help minimize this risk, it is recommended that you take the smallest effective dose of your medication and avoid exceeding the prescribed amount. Always consult with your healthcare provider to ensure that your treatment plan is safe and appropriate for your 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 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 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. 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, asthma, or a history of stroke, as these can also affect your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º-25ºC (68º-77ºF). It's important to avoid exposing it to excessive heat, which can reach up to 40ºC (104ºF), as this may compromise its effectiveness.

Before using the product, check the end flap for the expiration date and lot number to confirm its safety and usability. Proper storage and handling are key to maintaining the quality of the device, so please follow these guidelines closely.

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 is ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from conditions like menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

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

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve, stop taking ibuprofen and call your doctor immediately.

How should I take ibuprofen?

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist. 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 and stroke. Consult a doctor if you have a history of stomach problems or are taking other medications.

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 at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to ibuprofen?

If you experience symptoms like skin reddening, rash, or difficulty breathing, stop using ibuprofen and seek medical help immediately.

What is the recommended storage for ibuprofen?

Store ibuprofen between 20º-25ºC (68º-77ºF) and avoid excessive heat above 40ºC (104ºF).

Who should not take ibuprofen?

Do not use ibuprofen if you have ever had an allergic reaction to any pain reliever/fever reducer or if you are about to undergo heart surgery.

Packaging Info

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

Packaging configurations for Pain Relief Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, the common cold, backache, headache, 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 not exceed the directed amount. 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 maximum of 2 tablets may be taken. However, the total dosage must not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases under certain conditions, including but not limited to: exceeding the recommended dosage or duration of use, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (either prescription or over-the-counter), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an elevated 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.

General Precautions Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have a history of gastrointestinal issues, such as heartburn, or if they are currently taking diuretics. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice. Those who have experienced stomach bleeding or serious side effects from pain relievers or fever reducers should also consult a healthcare provider. Furthermore, patients under medical supervision for serious conditions or those taking aspirin for cardiovascular protection should be cautioned that ibuprofen may diminish the cardioprotective effects of aspirin.

Emergency Medical Help In cases of overdose, immediate medical attention or contact with a Poison Control Center is essential.

When to Stop Taking Ibuprofen and Contact a Doctor Patients should be instructed to discontinue ibuprofen and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, 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 contact their healthcare provider promptly.

Side Effects

Patients using ibuprofen should be aware of several serious adverse reactions associated with its use. Notably, ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

Additionally, the use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients who take higher doses or use the medication for extended periods, those who are 60 years of age or older, individuals taking anticoagulants or steroid medications, and patients with a history of stomach ulcers or bleeding problems. Consumption of three or more alcoholic drinks daily while using ibuprofen also increases the likelihood of stomach bleeding.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated when the medication is used in excess of the recommended dosage or for longer than directed.

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. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Other concerning signs include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, 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 issues, such as heartburn, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Those with a history of serious side effects from pain relievers or fever reducers should also consult a healthcare provider prior to use.

It is crucial to avoid ibuprofen if there has been a previous allergic reaction to any other pain reliever or fever reducer, and it should not be used immediately before or after heart surgery.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Pain Relief 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 in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is crucial for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

To minimize the risk of adverse effects, it is recommended that elderly patients take the smallest effective dose and not exceed the directed dosage. Close monitoring of these patients is advised to ensure safety and efficacy while managing their treatment.

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. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being 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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

Additionally, the use of ibuprofen has been associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk appears to be heightened when ibuprofen is used at higher doses or for extended periods beyond the recommended guidelines.

Gastrointestinal bleeding has also been reported, especially in patients with a history of stomach ulcers or bleeding disorders. Furthermore, cases of renal impairment have been documented in patients taking ibuprofen, particularly among those with pre-existing kidney conditions or dehydration.

Postmarketing data have shown that some patients may experience elevations in liver enzymes while using ibuprofen. There have also been reports of skin reactions, including severe conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other adverse reactions noted include dizziness, headache, and gastrointestinal discomfort.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have a history of stomach problems, such as heartburn, or if they are currently taking a diuretic. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Healthcare providers should also inform patients to seek medical advice before use if they have a warning regarding stomach bleeding. Patients with a history of problems or serious side effects from pain relievers or fever reducers should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be instructed to speak with their doctor or pharmacist if they are under care for any serious condition. It is crucial for patients taking aspirin for heart attack or stroke to discuss this with their healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. Lastly, patients should be reminded to consult their healthcare provider or pharmacist before using the medication if they are taking any other drugs.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

For proper inventory management, users are advised to check the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

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 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 Pain Relief 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 Pain Relief 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

Last AI update:

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.