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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 17, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet
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 2014
Label revision date
November 17, 2017
Manufacturer
Allegiant Health
Registration number
ANDA079129
NDC root
69168-335
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Ibuprofen is a medication that belongs to a class of drugs known as NSAIDs (nonsteroidal anti-inflammatory drugs). It is commonly used to provide fast relief from minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, ibuprofen can temporarily reduce fever, making it a versatile option for managing discomfort associated with various conditions, including the common cold.

Available in 200mg tablets, ibuprofen is a pain reliever and fever reducer that you can use to help alleviate your symptoms effectively.

Uses

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

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

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical 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 instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication.

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 use it right before or after heart surgery, as this could pose serious risks.

If you are pregnant, especially in the last three months, do not take this medication unless your doctor specifically instructs you to do so. Using it during this time may lead to complications for your unborn child or during delivery. Always consult with your healthcare provider if you have any concerns about using this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers, or who take blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Seek medical attention if you notice symptoms of heart problems or stroke, including chest pain, difficulty breathing, or weakness on one side of the body. It's advisable to talk to your doctor before using ibuprofen if you have a history of serious side effects from pain relievers, high blood pressure, heart disease, or other significant health issues. Lastly, avoid using ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional.

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.

This medication is a nonsteroidal anti-inflammatory drug (NSAID) and may lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs. Additionally, using ibuprofen for longer than directed can increase the risk of heart attack and stroke, which can be fatal.

You should seek emergency medical help if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222. Also, stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if your stomach pain worsens or lasts more than 10 days. If you experience any new symptoms or if fever or redness in the painful area persists, reach out to your healthcare provider.

Overdose

Taking too much ibuprofen can lead to serious symptoms. You might experience nausea (feeling sick), vomiting, stomach pain, drowsiness, headache, blurred vision, ringing in the ears, confusion, or even coma in severe cases. If you notice any of these signs after taking ibuprofen, it’s important to act quickly.

In the event of an overdose, seek immediate medical help or contact a Poison Control Center. Getting prompt assistance can be crucial for your safety and well-being. Always remember to use medications as directed to avoid these risks.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it 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 professional guidance.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets. However, make sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This risk is particularly significant if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that help prevent blood clots), or are using steroids. Additionally, combining this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), or consuming three or more alcoholic drinks daily while using it, can further elevate this risk.

To ensure your safety, always follow the recommended dosage and duration of use. If you have any concerns or are taking other medications, it's a good idea to discuss them with your healthcare provider to avoid potential complications. Your health and well-being are paramount, so staying informed and cautious is key.

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, or liver cirrhosis. Additionally, if you are taking a diuretic (a medication that helps your body get rid of excess fluid), you should discuss this with your healthcare provider as well.

Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring based on your kidney function. Always prioritize open communication with your healthcare team to ensure your safety and well-being.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other conditions like high blood pressure or heart disease, these may also influence how your liver functions and how you should be treated. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, using other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, alongside ibuprofen can increase your risk of stomach bleeding.

If you take ibuprofen for an extended period or in higher doses than recommended, you might also face a higher risk of heart attack or stroke. If you're on a diuretic (a type of medication that helps remove excess fluid from the body), it's crucial to consult your healthcare provider before using ibuprofen, as this combination may lead to complications. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is Ibuprofen used for?

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

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

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist, with a maximum of 6 tablets in 24 hours unless directed by a doctor.

Can I take Ibuprofen if I am pregnant?

You should not use Ibuprofen during the last 3 months of pregnancy unless directed by a doctor, as it may cause problems in the unborn child or complications during delivery.

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

Stop using Ibuprofen and seek medical help if you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Are there any serious risks associated with taking Ibuprofen?

Yes, taking Ibuprofen may increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed.

What should I do if I have a history of stomach problems?

Consult a doctor before using Ibuprofen if you have a history of stomach problems, such as ulcers or bleeding, as it may increase the risk of severe stomach bleeding.

What are the allergy warnings for Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

How should I store Ibuprofen?

Store Ibuprofen at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep it tightly closed and out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen 200 mg). 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

HealthA2Z® Ibuprofen Tablets contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its efficacy as a pain reliever and fever reducer. The formulation is designed to provide fast relief from pain. Each tablet is intended for oral administration and is comparable to the active ingredient found in Advil®.

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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be administered. However, it is imperative that the total dosage does 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 before administration.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. Administration is also contraindicated immediately before or after heart surgery due to potential complications.

Additionally, the use of ibuprofen during the last trimester of pregnancy is contraindicated unless specifically directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated in patients who use these medications in excess of the recommended dosage or for prolonged periods.

In cases of suspected overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential 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 while using the product, 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 beyond the directed dosage or duration.

Patients are advised to 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, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Other concerning symptoms warranting medical attention include fever that worsens or lasts more than three days, redness or swelling in the painful area, and the emergence of any new symptoms.

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, also necessitate immediate medical consultation.

Before using ibuprofen, patients should seek medical advice if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke. Patients taking diuretics should also consult a healthcare provider prior to use.

It is crucial to note that ibuprofen should not be used during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Ibuprofen may interact with several medications, particularly those within the nonsteroidal anti-inflammatory drug (NSAID) class and diuretics.

When ibuprofen is taken concurrently with aspirin, it may diminish the cardioprotective effects of aspirin, which is often prescribed for the prevention of heart attacks or strokes. Therefore, it is advisable to avoid the simultaneous use of ibuprofen and aspirin for patients who are using aspirin for cardiovascular protection.

The concomitant use of ibuprofen with other NSAIDs, whether prescription or nonprescription (such as naproxen), can elevate the risk of gastrointestinal complications, including stomach bleeding. Clinicians should exercise caution and consider alternative pain management strategies in patients requiring multiple NSAIDs.

Additionally, the risk of cardiovascular events, such as heart attack or stroke, may be heightened if ibuprofen is used in excess of the recommended dosage or for prolonged periods. It is essential for healthcare providers to monitor patients closely for signs of cardiovascular complications in these scenarios.

Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy, as there may be potential interactions that could affect the efficacy of the diuretic or lead to adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen 200 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription.

Additionally, the risk of stomach bleeding is amplified in patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to geriatric patients. It is advisable to evaluate the overall health status and medication regimen of elderly patients to mitigate potential adverse effects.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of ibuprofen during the last trimester is contraindicated 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 during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

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 also advisable for patients with high blood pressure, heart disease, or liver cirrhosis to seek medical advice before initiating treatment. Additionally, patients taking diuretics should discuss their renal function with their doctor to ensure safe use of the medication. Monitoring and appropriate dosing adjustments may be necessary for those with reduced kidney function to mitigate potential risks.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated carefully, as these factors may further complicate the management of hepatic impairment. It is advised that healthcare providers consider these comorbidities when determining the appropriate treatment regimen for patients with compromised liver function.

Overdosage

Overdosage of ibuprofen can lead to a range of severe symptoms that may significantly impact the patient's health. The clinical manifestations of ibuprofen overdosage include, but are not limited to, the following:

  • Gastrointestinal Symptoms: Patients may experience nausea, vomiting, and stomach pain.

  • Neurological Symptoms: Drowsiness, headache, blurred vision, and confusion are common neurological effects associated with overdose.

  • Auditory Symptoms: Tinnitus, or ringing in the ears, may also occur.

  • Severe Outcomes: In extreme cases, overdose can lead to coma.

In the event of an ibuprofen overdose, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate potential complications associated with ibuprofen overdosage.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, renal failure, and hepatic failure. Anaphylactic reactions and various skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been noted.

Cardiovascular events, including myocardial infarction and stroke, were reported alongside asthma exacerbation, hypertension, and edema. Additionally, thrombocytopenia, aseptic meningitis, and elevated liver enzymes were observed. Allergic reactions, including hives and facial swelling, were also documented.

It is important to note that these adverse reactions may not be directly related to the use of ibuprofen.

Patient Counseling

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

Patients should be instructed to consult a doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. They should also inquire about the relevance of the stomach bleeding warning, especially if they have a history of stomach issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should seek medical advice prior to use.

It is important for patients to ask a doctor or pharmacist before using this medication if they are currently taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Patients under a doctor's care for any serious condition or those taking other medications should also consult a healthcare professional before use.

When using this product, patients should take it with food or milk if they experience stomach upset. They should be made aware that the risk of heart attack or stroke may increase if they exceed the recommended dosage or duration of use.

Patients should 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 stomach pain that does not improve. They should also seek medical advice if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

For patients who are pregnant or breastfeeding, it is crucial to consult a healthcare professional before use. Special caution should be taken to avoid using ibuprofen during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.