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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
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 2015
Label revision date
May 1, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
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 2015
Label revision date
May 1, 2015
Manufacturer
Medline industries, Inc.
Registration number
ANDA076460
NDC root
53329-677
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.

If you are a consumer or patient please visit this version.

Drug Overview

Ibuprofen Tablets USP are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use ibuprofen to temporarily alleviate minor aches and pains caused by headaches, arthritis, backaches, menstrual cramps, muscular aches, toothaches, and even the common cold.

Each tablet contains 200 mg of ibuprofen, and they come in a bottle of 100 coated tablets. This medication works by blocking certain substances in the body that cause inflammation and pain, making it effective for managing discomfort and lowering fever.

Uses

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

This medication is designed to provide you with quick relief from these common ailments, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use.

Dosage and Administration

When you need relief from pain or fever, adults and children aged 12 years and older can take 1 tablet every 4 to 6 hours as long as symptoms continue. If you find that 1 tablet isn’t enough to manage your discomfort, you can take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage for their age and condition. Always follow these guidelines to use the medication safely and effectively.

What to Avoid

It's important to use this medication exactly as directed. Taking more than the recommended dose or using it for a longer period than prescribed can increase your risk of serious health issues, such as heart attack or stroke.

While there are no specific contraindications or dependence concerns mentioned, always be cautious and follow your healthcare provider's instructions to avoid any potential misuse or abuse of the medication. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional for guidance.

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, 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 issues, and those taking blood thinners or other NSAIDs. If you experience symptoms like feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor immediately.

It's important to be cautious if you have certain health conditions, such as high blood pressure, heart disease, or asthma, and to discuss your medical history with a healthcare provider before using ibuprofen. Always follow the recommended dosage, as taking more than directed can increase the risk of heart attack or stroke. If you have any new or worsening symptoms, seek medical advice promptly.

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. Avoid using ibuprofen if you have had an allergic reaction to pain relievers or if you are about to undergo heart surgery.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to talk to your doctor if you are taking aspirin for heart conditions, as ibuprofen may reduce its effectiveness. When taking ibuprofen, consider using it with food or milk to minimize stomach upset, and be cautious not to exceed the recommended dosage, as this can increase the risk of heart attack or stroke.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, reach out to your doctor if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, or if you notice any new symptoms.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional advice if you think something is wrong.

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 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.

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

If you are 60 years of age or older, it’s important to consult your doctor before using this medication. Older adults may have different health considerations, and your doctor can help ensure it’s safe for you. Be aware that taking more than the recommended dose or using the medication for longer than advised can increase the risk of serious issues like heart attack or stroke.

To help prevent stomach upset, consider taking the medication with food or milk. Remember, you should not exceed 6 tablets in a 24-hour period unless your doctor instructs you otherwise. Always aim to use the smallest effective dose to manage your symptoms safely.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and health conditions. For instance, if you're taking aspirin for heart protection, using ibuprofen might reduce its effectiveness. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can increase the risk of stomach bleeding. Using ibuprofen for longer than recommended may also raise your chances of having a heart attack or stroke.

If you're on blood thinners (medications that prevent blood clots) or steroids, or if you're taking a diuretic (a type of medication that helps remove excess fluid), it's crucial to talk to your healthcare provider before using ibuprofen. Always discuss any medications or tests with your doctor to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You can take this medication orally. For adults and children aged 12 and over, the recommended dose is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't effective, you may take 2 tablets, but do not exceed 6 tablets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Avoid using it during the last three months of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is Ibuprofen Tablets USP used for?

Ibuprofen Tablets USP are used to temporarily relieve minor aches and pains from headaches, arthritis, backaches, menstrual cramps, muscular aches, toothaches, and the common cold, as well as to reduce fever.

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. If pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin, and it can lead to stomach bleeding, particularly in individuals over 60 or those with a history of stomach issues.

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

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

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is there a risk of heart attack or stroke with Ibuprofen?

Yes, the risk of heart attack or stroke may increase if you use Ibuprofen more than directed or for longer than directed.

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

If you have a history of stomach problems, such as ulcers or bleeding, consult a doctor before using Ibuprofen.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Tablets USP are nonsteroidal anti-inflammatory drugs (NSAIDs) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen. The product is available in a package containing 100 coated tablets, each formulated to provide effective analgesic and antipyretic properties.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily 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 recommended to consult a doctor prior to administration.

Contraindications

There are no explicit contraindications identified for this product. However, it is important to note that the risk of heart attack or stroke may increase if the product is used in excess of the recommended dosage or for a duration longer than directed. Therefore, caution is advised in patients with a history of cardiovascular events.

Warnings and Precautions

Ibuprofen may cause 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of 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 taking anticoagulants or steroid medications, are using 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. Additionally, ibuprofen should not be used in individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, or immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients taking diuretics or those under medical supervision for serious conditions should also seek medical advice before using ibuprofen. It is essential to inform patients that taking aspirin for heart attack or stroke may be less effective when used concurrently with ibuprofen.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset. Caution should be exercised, as the risk of heart attack or stroke may increase with dosages exceeding the recommended amount or with prolonged use.

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.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, ibuprofen carries a warning for the potential risk of severe stomach bleeding, which 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.

Common adverse reactions may include gastrointestinal symptoms. Patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other indications to stop use include worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients inform their healthcare provider if they are under treatment for any serious condition, are taking aspirin for cardiovascular protection, or are using any other medications.

To mitigate gastrointestinal discomfort, patients are advised to take ibuprofen with food or milk. It is important to note that exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

Drug Interactions

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

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen may diminish the cardioprotective effects of aspirin when both are taken concurrently for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid using ibuprofen in conjunction with aspirin for these indications.

The concomitant use of ibuprofen with other NSAIDs, whether prescription or nonprescription (such as aspirin or naproxen), can elevate the risk of gastrointestinal bleeding. It is recommended that patients refrain from using multiple NSAIDs simultaneously to mitigate this risk.

Cardiovascular Risk Prolonged use of ibuprofen, particularly at doses exceeding the recommended guidelines, may increase the risk of heart attack or stroke. Patients should be counseled on adhering strictly to dosing instructions to minimize this risk.

Anticoagulants and Steroids Patients who are on anticoagulant therapy or corticosteroids should seek medical advice prior to using ibuprofen. The combination may enhance the risk of adverse effects, including bleeding.

Diuretics Patients taking diuretics are also advised to consult with a healthcare provider before initiating ibuprofen therapy, as interactions may affect the efficacy of the diuretic or lead to other complications.

In summary, careful monitoring and consultation with healthcare professionals are essential for patients taking ibuprofen alongside these medications to ensure safety and efficacy.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, are advised to consult a healthcare provider prior to using this medication. It is important to note that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for a duration longer than directed.

To mitigate potential gastrointestinal discomfort, geriatric patients should take the medication with food or milk. Additionally, it is crucial that elderly patients do not exceed a maximum of 6 tablets within a 24-hour period unless specifically directed by a healthcare professional. The smallest effective dose should always be utilized to ensure safety and minimize risks associated with higher dosages. Regular monitoring and consultation with a healthcare provider are recommended to ensure appropriate use in this population.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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 during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing. In the event of suspected overdosage, immediate medical attention should be sought.

Healthcare providers should implement standard supportive measures, which may include symptomatic treatment and monitoring of vital signs. Additionally, it is recommended to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident and any interventions performed is crucial for ongoing patient care and safety.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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, or experiencing stomach pain that does not improve. Additionally, they should seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

It is important for patients to consult a healthcare provider before using this medication if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients should also be advised to inform their healthcare provider if they are taking a diuretic or if they are under a doctor's care for any serious condition.

Patients should be cautioned about the potential interaction with aspirin, as ibuprofen may reduce the cardiovascular benefits of aspirin when taken for heart attack or stroke prevention. They should also be encouraged to discuss any other medications they are currently taking with their healthcare provider or pharmacist.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should be advised that the medication is administered orally. For adults and children 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 respond to 1 tablet, 2 tablets may be taken, but the total should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to use. It is particularly important to avoid ibuprofen during the last trimester of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and be informed that in the event of an overdose, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

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.