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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
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
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 2021
Label revision date
October 31, 2025
Manufacturer
TOP CARE (Topco Associates LLC)
Registration number
ANDA078682
NDC root
36800-193
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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 medication available in 200 mg capsules that serves as both a pain reliever and a 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 headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, it helps to 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 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, helping you feel more comfortable when you're not feeling well.

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 dose is 1 capsule every 4 to 6 hours as needed while symptoms persist.

If you find that 1 capsule isn't enough to relieve your pain or fever, you can take 2 capsules. However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise. If you are considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first.

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 this medication right before or after undergoing heart surgery, as it may pose risks to your health. Always consult with your healthcare provider if you have any concerns or questions about your medications.

Side Effects

This product may cause a severe allergic reaction, particularly in individuals who are allergic to aspirin. Symptoms of such a reaction can include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. If you experience any of these symptoms, stop using the product immediately and seek medical help.

You should avoid using this product if you have a history of allergic reactions to pain relievers or fever reducers, or if you are about to undergo heart surgery. It's important to consult a doctor before use if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking a diuretic. While using this product, take it with food or milk to help prevent stomach upset. If you notice signs of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), or if you experience symptoms of heart problems or stroke (like chest pain or weakness on one side of the body), stop using the product and contact a doctor. Additionally, if your pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, seek medical advice. If you are pregnant or breastfeeding, consult a healthcare professional before use, especially after 20 weeks of pregnancy, as it may pose risks to the unborn child.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you are pregnant, over 60 years old, have a serious medical condition, or are taking other medications. Be cautious if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. This product can cause severe allergic reactions, especially in those allergic to aspirin. Symptoms may include hives, swelling, difficulty breathing, or skin rashes. If you experience any of these, stop using the product and seek medical help immediately.

You should not use this product if you have ever had an allergic reaction to pain relievers or fever reducers, or if you are about to undergo heart surgery. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop using the product and contact your doctor. Additionally, if you experience chest pain, trouble breathing, weakness on one side of your body, or any new symptoms, seek medical attention right away.

In case of an overdose, get emergency medical help or contact a Poison Control Center immediately. Regular lab tests may be necessary if you have certain health conditions, so keep your healthcare provider informed about your health status and any medications you are taking.

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 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 delivery issues for your baby or complications during the delivery process. Always seek guidance from your doctor to ensure the safety of both you and your child.

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 delivery issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is one capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may take two capsules, but be sure not to exceed six capsules in a 24-hour period unless directed by a doctor. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns about your child's health.

Geriatric Use

If you are 60 years or older, it’s important to consult your doctor before using this medication. This is especially crucial if you are pregnant, managing a serious health condition, taking other medications, or have any stomach issues. Your doctor can help ensure that this medication is safe and appropriate for your specific health needs. Always prioritize open communication with your healthcare provider to address any concerns you may have.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider will need to assess your overall health, especially if you also have conditions like high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This ensures that the treatment is safe and appropriate for your specific situation. Always prioritize open communication with your doctor regarding your kidney health and any other medical conditions you may have.

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 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 don’t hesitate to ask questions or express any concerns you may have.

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 share your complete list of medications and any lab tests you undergo, as this can help prevent any potential issues and support your overall health.

Storage and Handling

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

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these storage and handling guidelines will help ensure the product remains safe and effective for your use.

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 lead to complications for both the unborn child and during delivery.

FAQ

What is Ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

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

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

Are there any contraindications for using Ibuprofen?

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

What should I do if I experience an allergic reaction?

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, stop using Ibuprofen and seek medical help immediately.

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 stomach problems?

If you have a history of stomach problems, such as heartburn, or if stomach bleeding warnings apply to you, consult your doctor before using Ibuprofen.

How should I take Ibuprofen to avoid stomach upset?

If you experience stomach upset, take Ibuprofen with food or milk.

What are the storage conditions for Ibuprofen?

Store Ibuprofen at 20° to 25°C (68° to 77°F) and protect it from excessive heat above 40°C (104°F) and light.

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

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and 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 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative that the total daily dosage does not exceed 6 capsules 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 before administration.

Contraindications

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

Warnings and Precautions

Patients should consult their healthcare provider prior to using this product if they are pregnant, are under medical supervision for a serious condition, are aged 60 or over, are taking any other medications, or have a history of stomach problems.

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

The product is contraindicated in individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Healthcare professionals should advise patients to seek medical guidance before using this product if any of the following conditions apply:

  • A history of stomach bleeding.

  • Previous adverse reactions to pain relievers or fever reducers.

  • A history of gastrointestinal issues, such as heartburn.

  • Existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

  • Concurrent use of diuretics.

  • Being under medical care for any serious health condition.

  • Use of aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

  • Use of any other medications.

Patients should discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding:

  • Feeling faint.

  • Vomiting blood.

  • Presence of bloody or black stools.

  • Persistent stomach pain that does not improve.

Additionally, they should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, including:

  • Chest pain.

  • Difficulty breathing.

  • Weakness localized to one side of the body.

  • Slurred speech.

  • Swelling in the legs.

Patients should also stop using the product if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

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

Side Effects

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

Patients should not use this product if they have a history of allergic reactions to any other pain reliever or fever reducer, or if they are scheduled for heart surgery, either immediately before or after the procedure.

Prior to using this product, patients are advised to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, serious side effects from pain relievers or fever reducers, stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before use.

While using this product, it is recommended that patients take it with food or milk to mitigate potential stomach upset.

Patients should discontinue use and consult a healthcare professional 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 seek medical attention if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients should stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may lead to delivery complications for the unborn child or issues during delivery.

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 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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed a total of 6 capsules within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, should consult their healthcare provider prior to using this medication. It is essential for geriatric patients to disclose any serious medical conditions they may be managing, as well as any other medications they are currently taking. Additionally, those with a history of stomach problems should exercise caution and seek medical advice before initiating treatment.

Close monitoring may be warranted in this population to ensure safety and efficacy, given the potential for altered pharmacokinetics and increased sensitivity to adverse effects in elderly patients.

Pregnancy

Pregnant patients and women 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. The use of ibuprofen during this period may be associated with potential delivery complications and adverse fetal outcomes. Therefore, healthcare providers should carefully evaluate the risks and benefits before prescribing this medication to 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 physician, as it may lead to delivery complications for the unborn child. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential risks and benefits 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. Caution is advised for individuals with 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 overall treatment plan. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication 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 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 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’s health status.

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 delivery 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 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, cases of cardiovascular events, such as myocardial infarction and stroke, have been associated with ibuprofen use. Some patients have experienced allergic reactions, including anaphylaxis and angioedema. Furthermore, elevated blood pressure has been noted in patients taking ibuprofen, along with instances of gastrointestinal perforation and ulceration.

Patient Counseling

Patients should be advised 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.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach bleeding or if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, patients with a history of stomach issues, such as heartburn, should also seek medical advice prior to use.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or those who have had a stroke should be advised to consult a doctor before using this medication. It is also important for patients taking a diuretic to discuss their use of this medication with their healthcare provider.

Furthermore, patients under a doctor's care for any serious condition should be encouraged to speak with their doctor or pharmacist before using this medication. Those taking aspirin for heart attack or stroke should be informed that ibuprofen may reduce the effectiveness of aspirin and should consult a healthcare professional before use. Lastly, patients should be reminded to discuss any other medications they are taking with their doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

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 lead to delivery complications for the unborn child or during the delivery process.

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.