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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 2022
Label revision date
December 11, 2025
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 2022
Label revision date
December 11, 2025
Manufacturer
Lil' Drug Store Products, Inc.
Registration number
ANDA075010
NDC root
66715-8152
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Drug Overview

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. It is commonly used to temporarily alleviate minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

In addition to its pain-relieving properties, ibuprofen is effective in lowering fever, making it a versatile option for managing discomfort and illness. You can find it in various forms, including 200 mg tablets, and it is often compared to other over-the-counter pain relievers like Advil.

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

When using this medication, it’s important to follow the directions carefully. You should take the smallest effective dose to manage your symptoms. 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 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 best to consult with a doctor first to ensure it’s safe and appropriate for them. Always remember to take the medication as directed to avoid any potential risks.

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. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction 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. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

There are important warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can elevate these risks, particularly if used in higher doses or for extended periods. You should stop using ibuprofen and consult a doctor if you experience symptoms of stomach bleeding (like faintness, vomiting blood, or black stools) or signs of heart problems or stroke (such as chest pain, difficulty breathing, or weakness on one side of the body). Always talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or other serious health conditions.

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, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. There is also an increased risk of heart attack and stroke with ibuprofen, especially if used in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics or other medications. If you experience symptoms of stomach bleeding (like feeling faint, vomiting blood, or having black stools), signs of heart problems or stroke (such as chest pain, trouble breathing, or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected, stop taking ibuprofen and contact your doctor. In case of an overdose, seek emergency medical help or contact 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using 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 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 you have a child 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, but be sure not to exceed 6 tablets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

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, there is a higher chance of experiencing severe stomach bleeding. This risk means that you should discuss any medications you are taking with your healthcare provider, especially if they are known to affect the stomach or blood.

Always make sure to follow your doctor's advice regarding dosages and any necessary precautions. Your healthcare provider can help you understand how to manage your medications safely to minimize risks and ensure your well-being.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, including 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 health needs. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe liver scarring), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition closely to ensure your safety.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to 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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult 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 nonsteroidal anti-inflammatory drug (NSAID) used as a pain reliever and fever reducer.

What conditions does Ibuprofen temporarily relieve?

Ibuprofen 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 12 years and older?

Adults and children 12 years and older 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?

Stop using Ibuprofen and call your doctor if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially if you are 20 weeks or later in pregnancy, as it may cause problems for the unborn child.

What are the allergy alerts associated with Ibuprofen?

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

Are there any contraindications for using Ibuprofen?

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

What should I do if I overdose on Ibuprofen?

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

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 (ibuprofen tablet, film coated). 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 specified 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 as follows:

  • Administer 1 tablet every 4 to 6 hours as needed while symptoms persist.

  • If pain or fever does not adequately respond to 1 tablet, 2 tablets may be taken.

  • The maximum allowable dosage is 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 for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria:

  • Age 60 or older

  • History of stomach ulcers or bleeding disorders

  • Concurrent use of blood thinners (anticoagulants) or steroid medications

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

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

  • Exceeding the recommended dosage or duration of use

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced 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 use if any of the following conditions apply:

  • The patient is at risk for stomach bleeding as outlined above

  • The patient has experienced serious side effects from pain relievers or fever reducers

  • A history of gastrointestinal issues, such as heartburn, exists

  • The patient has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke

  • The patient is taking diuretics

Additionally, patients should be counseled to seek advice from a doctor or pharmacist if they are:

  • Under medical care for any serious condition

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

  • Using any other medications

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

When to Stop Taking Ibuprofen Patients should discontinue use and contact a healthcare provider if they experience any of the following:

  • 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, difficulty breathing, unilateral weakness, slurred speech, or leg swelling

  • Worsening pain that persists beyond 10 days

  • Fever that worsens or lasts more than 3 days

  • Redness or swelling in the affected area

  • Any new or unusual symptoms

These warnings and precautions are critical for the safe administration of ibuprofen and should be communicated effectively to patients.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or prior strokes, or if they are taking diuretics.

It is crucial to avoid the use of ibuprofen in individuals with a history of allergic reactions to any 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 Ibuprofen (ibuprofen tablet, film coated). 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 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 benefits and risks is essential when treating this population to ensure optimal safety and efficacy.

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 pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a 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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. 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 of an overdose may include supportive care and symptomatic treatment, tailored to the specific clinical presentation. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the severity of symptoms and the substance involved.

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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has indicated that several adverse reactions have been reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes.

Additional adverse reactions noted encompass allergic reactions, such as anaphylaxis, as well as skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Reports of cardiovascular events, including heart attack and stroke, have also been associated with the use of NSAIDs, including ibuprofen.

Hypertension has been documented in patients taking ibuprofen. Furthermore, serious skin reactions, such as exfoliative dermatitis and erythema multiforme, have been reported. Rare cases of liver failure have been observed, particularly in individuals with pre-existing liver disease. Renal failure has also been reported, especially in patients with pre-existing renal impairment or those concurrently using diuretics.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be informed 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 stomach pain that does not improve. They should also seek medical advice 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 swelling in the legs.

It is important to instruct patients to discontinue use and consult a healthcare professional 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. They should also be encouraged to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have experienced serious side effects from pain relievers or fever reducers in the past.

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to seek medical guidance before using this medication. Furthermore, patients taking diuretics or under a doctor's care for any serious condition should consult their healthcare provider or pharmacist prior to use.

Lastly, patients should be informed to discuss with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. They should also be encouraged to consult a healthcare professional before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°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 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.

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.