Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
March 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
March 15, 2024
Manufacturer
WALGREENS
Registration number
ANDA079205
NDC root
0363-1610
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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

This medication is designed to temporarily relieve minor aches and pains, such as those caused by headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, it helps to reduce fever. If you're experiencing any of these discomforts, this medication may provide you with the relief you need.

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. It's important to remember that while it can help with these symptoms, it does not address the underlying causes of your discomfort.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should not take more than the recommended amount, and it's best to use the smallest dose that effectively relieves your symptoms. For adults and children aged 12 years and older, the typical dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If you find that 1 capsule isn't enough to relieve your pain or fever, you can take 2 capsules instead.

However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise. If you are considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first. Always prioritize safety and follow these guidelines to ensure effective use of the 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, it is important not to use this medication right before or after heart surgery, as it may pose risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your eligibility to use 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, 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 also 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 feeling faint, vomiting blood, or having black stools), signs of heart problems or stroke (such as chest pain or slurred speech), or if your pain or fever worsens or lasts longer than expected. Always consult a doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Signs of an allergic reaction include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication may also 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 it for longer than recommended. Additionally, using ibuprofen can increase the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), if your pain worsens or lasts more than 10 days, or if you develop any new symptoms. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can 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 a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is one capsule every 4 to 6 hours as needed for symptoms. If one capsule isn't enough to relieve pain or fever, you can give two capsules, but be careful not to exceed six capsules in a 24-hour period unless a doctor advises otherwise. 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 or older, there is a higher chance of experiencing severe stomach bleeding. Additionally, using medications beyond the recommended dosage or for longer than advised can increase your risk of heart attack, heart failure, and stroke. This is particularly concerning for older adults, so it's crucial to follow dosage instructions carefully.

Before starting any new medication, you should consult with your doctor, especially if you have conditions like high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, asthma, or a history of stroke. These health issues can be more common in older adults and may affect how you should use certain medications. Always prioritize your health and safety by discussing your medical history with your healthcare provider.

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 and what steps to take for your safety.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and health conditions. For instance, if you are taking aspirin for heart attack or stroke prevention, using ibuprofen may reduce its effectiveness. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, combining these with ibuprofen can increase your risk of stomach bleeding.

If you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, be cautious, as this can also heighten the risk of stomach bleeding. Lastly, if you are on a diuretic (a medication that helps remove excess fluid from the body), it's best to consult your healthcare provider before using ibuprofen. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

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, as temperatures above 40°C (104°F) can damage the product.

When handling the device, always do so with clean hands and in a clean environment to maintain its integrity and safety. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is the primary use of this medication?

This medication temporarily relieves minor aches and pains from headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

What should I do if I experience stomach bleeding symptoms?

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve, stop using the medication and ask a doctor immediately.

What are the dosage instructions for adults and children over 12?

Adults and children 12 years and over should take 1 capsule every 4 to 6 hours while symptoms persist, not exceeding 6 capsules in 24 hours unless directed by a doctor.

Are there any warnings I should be aware of?

Yes, this medication may cause severe allergic reactions, stomach bleeding, and increases the risk of heart attack and stroke, especially if used more than directed.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. Avoid using this medication at 20 weeks or later in pregnancy unless directed by a doctor.

Who should not use this medication?

Do not use this medication if you have 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 pain or fever does not improve?

If pain or fever does not respond to 1 capsule, you may take 2 capsules. However, do not exceed the recommended dosage.

How should I store this medication?

Store the medication at 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. 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 specific description details are available for SPL code 34089-3.

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 administration guidelines. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician before administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 indicative of an allergic reaction 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. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

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

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed 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 in patients who exceed the recommended dosage or duration of treatment.

Monitoring and Discontinuation Criteria Healthcare professionals should advise patients to discontinue ibuprofen and consult a physician if they experience any of the following symptoms indicative of stomach bleeding:

  • Feeling faint

  • Vomiting blood

  • Presence of bloody or black stools

  • Persistent stomach pain that does not improve

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

  • Chest pain

  • Difficulty breathing

  • Weakness on one side of the body

  • Slurred speech

  • Swelling in the legs

Patients should also be instructed to stop use and consult a healthcare provider if:

  • Pain worsens or persists beyond 10 days

  • Fever worsens or lasts more than 3 days

  • Redness or swelling occurs in the affected area

  • Any new symptoms arise.

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

Side Effects

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

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients who 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 elevated when the medication is used in higher doses or for extended periods.

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, if pain persists beyond 10 days, fever worsens or lasts more than three days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to inform the healthcare provider if the patient is taking a diuretic or is under medical care for any serious condition. Additionally, patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

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

Pharmacodynamic Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid the simultaneous use of ibuprofen and aspirin for these indications.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider alternative pain management strategies in individuals requiring these medications.

Pharmacokinetic Interactions

The use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen, increases the risk of stomach bleeding. It is advisable for patients to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

Patients who are on diuretics should seek medical advice prior to initiating ibuprofen therapy, as the combination may require careful monitoring and potential dosage adjustments 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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dose of 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this medication. Caution is advised when prescribing to this population, and healthcare providers should closely monitor for any signs of gastrointestinal bleeding.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients, especially when the medication is used in excess of the recommended dosage or for prolonged periods. It is essential for healthcare providers to assess the appropriateness of treatment duration and dosage in elderly patients to mitigate these risks.

Before initiating therapy, healthcare providers should inquire about the presence of comorbid conditions that are more common in elderly patients, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These conditions may necessitate further evaluation and consideration of alternative treatment options or dosage adjustments to ensure patient safety.

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 ibuprofen in pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective treatment planning.

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 identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when utilized in higher doses or for extended durations. It is important to note that reports of adverse reactions may not be fully captured in clinical trials, and the actual incidence may vary.

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 informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to instruct patients not to use this medication right before or after heart surgery.

Patients should be made aware of the signs of stomach bleeding and instructed to stop use and consult a doctor if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to stop use and seek medical attention if they exhibit symptoms of heart problems or stroke, including chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling.

Patients should also be counseled to stop use and consult a doctor if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is essential to recommend that patients ask a doctor before use if the stomach bleeding warning applies to them, or if they have experienced problems or serious side effects from taking 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 encouraged to consult a doctor before using this medication. Additionally, patients taking a diuretic or under a doctor's care for any serious condition should seek advice from a doctor or pharmacist before use.

Lastly, patients should be informed to consult a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. It is also advisable for patients to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

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). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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 critical 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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

Last AI update:

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.