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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)
Marketed in the U.S.
Since 1988
Label revision date
June 2, 2025
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
Marketed in the U.S.
Since 1988
Label revision date
June 2, 2025
Manufacturer
Rite Aid Corporation
Registration number
ANDA075010
NDC root
11822-0291

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Drug Overview

Ibuprofen is a medication available in 200 mg tablets that acts as a pain reliever and fever reducer. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can use ibuprofen to temporarily relieve minor aches and pains caused by various conditions, including muscular aches, headaches, menstrual cramps, backaches, toothaches, and even minor arthritis pain. Additionally, it helps to reduce 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 muscular aches, headaches, menstrual cramps, backaches, toothaches, and even discomfort from the common cold. It can also help with minor pain associated with arthritis.

In addition to alleviating pain, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should take the smallest effective dose, which means using just enough to relieve your symptoms without taking more than necessary. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 to 6 hours as needed. If your pain or fever doesn’t improve with 1 tablet, 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 have children under 12 years old, it's best to consult a doctor before giving them this medication. Remember, this medication is taken orally, so you should swallow the tablet with water. Always keep track of how many tablets you've taken to avoid exceeding the recommended dosage.

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, do not take it right before or after heart surgery, as this could pose serious risks to your health. Always consult with your healthcare provider if you have any questions or concerns about your medications.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include facial swelling, hives, difficulty breathing (asthma), and skin rashes. Additionally, this medication carries a risk of severe stomach bleeding, especially if you take it for longer than recommended, consume alcohol regularly, or have a history of stomach ulcers or bleeding issues.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods. If you experience symptoms such as chest pain, slurred speech, or severe stomach pain, you should stop using ibuprofen and consult a doctor immediately. It's important to talk to your healthcare provider before using ibuprofen if you have conditions like high blood pressure, heart disease, or a history of stomach problems.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Signs of an allergic reaction include facial swelling, hives, asthma (wheezing), and skin rashes. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. Additionally, ibuprofen may lead to severe stomach bleeding, particularly if you take it for longer than recommended, consume alcohol regularly, or have a history of stomach ulcers. It can also increase the risk of heart attack and stroke, especially if used in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have conditions like high blood pressure, heart disease, or a history of stomach problems. It's also important to talk to your doctor if you are taking other medications, especially aspirin, as ibuprofen may reduce its effectiveness. If you suspect an overdose, contact a medical professional or Poison Control Center right away.

You should stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek immediate help if you experience symptoms of heart problems or stroke, like chest pain or weakness on one side of your body. Additionally, if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, contact your doctor.

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.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to reach out for professional assistance. Your health and safety are 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 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 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 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 have any questions about your child's health.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when taking nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. Additionally, using NSAIDs—except for aspirin—can increase your risk of heart attack, heart failure, and stroke. This risk becomes even greater if you take more than the recommended dose or use these medications for an extended period.

To stay safe, always follow your healthcare provider's instructions regarding dosage and duration of NSAID use. If you have any concerns or experience unusual symptoms, be sure to discuss them with your doctor. Your health and safety are the top priority, especially as you navigate medication options.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

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 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.

Drug Interactions

It's important to be aware that certain medications can interact with each other, which may affect how well they work or increase the risk of side effects. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, combining ibuprofen with blood thinners (medications that help prevent blood clots) or steroids can significantly raise the risk of severe stomach bleeding.

To ensure your safety and the effectiveness of your medications, always discuss any other drugs you are taking with your healthcare provider or pharmacist before starting ibuprofen. They can help you understand potential interactions and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance and safety of your product, it's important to store it properly. Keep it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). Avoid exposing it to excessive heat, as temperatures above 40°C (104°F) can damage the product.

Before using the product, check the end flap for the expiration date and lot number to confirm its validity. Following these guidelines will help maintain the product's effectiveness and safety.

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?

Ibuprofen is a pain reliever and fever reducer that belongs to a class of drugs known as NSAIDs (nonsteroidal anti-inflammatory drugs).

What conditions does ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains due to muscular aches, headaches, menstrual cramps, backaches, the common cold, toothaches, 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, with a maximum of 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding symptoms?

If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop taking ibuprofen and call your doctor immediately.

Can ibuprofen be used during pregnancy?

If you are pregnant or breastfeeding, consult a health professional before using ibuprofen, especially after 20 weeks of pregnancy, as it may cause complications.

What are the allergy alerts associated with ibuprofen?

Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin, with symptoms including facial swelling, hives, and difficulty breathing.

What precautions should I take before using ibuprofen?

Before using ibuprofen, ask a doctor if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stomach problems.

What should I do if I take more ibuprofen than directed?

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

What are the storage conditions for ibuprofen?

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

Is there a satisfaction guarantee for ibuprofen?

Yes, if you are not satisfied with ibuprofen, you can receive a refund.

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 Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each package contains 12 coated tablets. The product features a tamper-evident design, and it is advised not to use the product if the imprinted safety seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, headaches, menstrual cramps, backaches, the common cold, toothaches, 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 taken orally 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 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 physician before administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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 may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include facial swelling, shock, hives, asthma (wheezing), skin reddening, blisters, and rash. 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 increases under certain conditions, including prolonged use beyond the recommended duration, concurrent use of blood thinners (anticoagulants) or steroid medications, consumption of three or more alcoholic beverages daily while using this product, use of other NSAIDs (either prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), being aged 60 years or older, or having a history of stomach ulcers or bleeding disorders.

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 excessive or prolonged use.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, a history of stroke, or if the stomach bleeding warning is applicable. Patients with a history of stomach issues, such as heartburn, those taking diuretics, or those who have experienced significant side effects from pain relievers or fever reducers should also seek medical advice before use.

Furthermore, it is essential for patients to inform their healthcare provider or pharmacist if they are taking any other medications, particularly if they are using aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under medical supervision for serious conditions should also consult their healthcare provider before using this product.

In the case of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, 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 seek medical advice promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include facial swelling, shock, hives, asthma (wheezing), skin reddening, blisters, and rash.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients who take more than the recommended dosage or for an extended period, those using anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily, patients aged 60 or older, and those with a history of stomach ulcers or bleeding problems.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or duration.

Patients are advised to discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, difficulty breathing, leg swelling, or weakness on one side of the body, also warrant immediate medical attention. Furthermore, if pain persists for more than 10 days, fever worsens or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare professional if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Those with a history of stomach problems, such as heartburn, or who are taking diuretics should also seek medical guidance. It is important to note that ibuprofen should not be used by individuals who have previously experienced an allergic reaction to any other pain reliever or fever reducer, nor should it be used immediately before or after heart surgery.

Drug Interactions

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

Pharmacodynamic Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. It is advisable for patients to consult with a healthcare professional before combining these medications to ensure optimal therapeutic outcomes.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. Patients taking these combinations should be closely monitored for signs of gastrointestinal complications, and healthcare providers may consider alternative pain management strategies or additional protective measures.

General Recommendations

Patients are strongly encouraged to seek guidance from a healthcare provider or pharmacist prior to initiating ibuprofen if they are currently taking any other medications. This precaution helps to mitigate potential interactions and ensures 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 for symptom relief. 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 when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further heightened in geriatric patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage adjustments and ongoing assessment of the patient's cardiovascular status is advised when prescribing NSAIDs to elderly individuals.

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 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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

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

Additionally, cases of cardiovascular events, including heart attack and stroke, have been reported. Other adverse reactions include allergic reactions, such as anaphylaxis and angioedema. Instances of elevated blood pressure in patients taking ibuprofen have been noted, as well as reports of worsening asthma symptoms.

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 crucial to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after undergoing heart surgery.

Patients must be instructed to stop using the medication 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. They should also be made aware of the symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, or weakness on one side of the body, and advised to seek medical attention if these occur.

Healthcare providers should emphasize that patients need to stop using the medication 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 important for healthcare providers to recommend that patients consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should also be encouraged to discuss their medical history regarding stomach problems, such as heartburn, and to inform their healthcare provider if they are taking a diuretic or have experienced serious side effects from pain relievers or fever reducers.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are taking any other drugs, particularly if they are using aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition should also seek guidance before using this product.

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 check the end flap for the expiration date and lot number to ensure product integrity.

For optimal storage, the product should be maintained at a temperature range of 20°-25°C (68°-77°F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to preserve the product's efficacy and safety. Proper handling and storage conditions are vital to maintaining the quality of the product throughout its shelf life.

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.

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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.