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Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
September 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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 2004
Label revision date
September 15, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA075217
NDC root
41250-255
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 is a medication available in an oral suspension form, specifically designed for infants aged 6 to 23 months. It acts as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. This concentrated formula is berry-flavored, dye-free, and lasts up to 8 hours, providing effective relief for your little one when they need it most.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adult use. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which is based on your child's weight. If possible, use weight to determine the dose; if not, you can use age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving any medication. For children weighing between 12 to 17 pounds (6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months old), the dose is 1.875 mL.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not provide specific guidelines or warnings. There are no stated risks or contraindications associated with taking ibuprofen while pregnant, and no dosage adjustments are recommended for pregnant individuals. Additionally, the insert does not mention any special precautions you should take if you are pregnant.

However, since the safety of any medication can vary based on individual circumstances, it's always best to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises you to do so. For younger children, it's important to consult a doctor before administering the medication, especially if your child is under 6 months old. For children aged 6 to 23 months, the dosage varies: if your child weighs between 12-17 pounds (6-11 months), give 1.25 mL, and for those weighing 18-23 pounds (12-23 months), the dose is 1.875 mL.

Before giving this medication, check with your doctor if your child has any history of stomach issues, is not drinking enough fluids, has lost fluids from vomiting or diarrhea, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is on a diuretic (a type of medication that helps remove excess fluid). If your child shows signs of stomach bleeding, heart problems, or stroke, does not feel better within 24 hours, or if symptoms worsen or new symptoms appear, stop using the medication and consult a doctor immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your healthcare provider 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 health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check that the printed neckband is intact; do not use the product if the neckband is broken or missing, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen?

Ibuprofen is an oral suspension pain reliever and fever reducer, available in a concentration of 50 mg per 1.25 mL.

What age group is ibuprofen suitable for?

Ibuprofen is intended for infants ages 6 to 23 months.

How does ibuprofen work?

Ibuprofen reduces fever and relieves minor aches and pains due to conditions like the common cold, flu, sore throat, headaches, and toothaches.

What are the dosing instructions for ibuprofen?

For infants 12-17 lbs (6-11 months), the dose is 1.25 mL; for 18-23 lbs (12-23 months), the dose is 1.875 mL. Always use the enclosed syringe for measurement.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within 24 hours.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can ibuprofen be given with food?

Yes, you can give ibuprofen with food or milk if stomach upset occurs.

What should I do in case of an overdose?

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

Is ibuprofen safe to use during pregnancy or while nursing?

The provided information does not specify any risks or recommendations regarding the use of ibuprofen during pregnancy or lactation.

How should ibuprofen be stored?

Store ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

This product is intended for pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided below. When possible, dosing should be based on the child's weight; if weight is not available, age may be used as a guide.

Dosing should be measured using the dosing device provided with the product; other devices should not be used to ensure accurate dosing. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing.

If necessary, the dose may be repeated every 6 to 8 hours, but it is important not to exceed 4 doses in a 24-hour period.

Dosing Chart:

  • For children weighing under 6 lbs and aged under 6 months, consult a doctor for appropriate dosing.

  • For children weighing 12-17 lbs (ages 6-11 months), the recommended dose is 1.25 mL.

  • For children weighing 18-23 lbs (ages 12-23 months), the recommended dose is 1.875 mL.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, it is crucial to consult a physician promptly. Ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical attention is warranted. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, a healthcare professional should be consulted. Any new symptoms that develop should also prompt a medical evaluation.

In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

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

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, exceeding the recommended dosage or duration of use increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the recommended guidelines.

In clinical observations, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's direction.

Patients are instructed to discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is advisable for patients to consult a doctor if any of the following apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, dehydration due to vomiting or diarrhea, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended to consult a healthcare professional if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, it is recommended that parents or caregivers consult a doctor for infants under 6 months. For children aged 6 to 23 months, the following dosing guidelines apply: for those weighing 12-17 lbs (6-11 months), the dose is 1.25 mL; for those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

Prior to administration, it is essential to consult a healthcare provider if the child has a history of stomach problems, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, caution is advised for children with asthma or those taking diuretics.

Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the affected area, or develops any new symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment plan based on the individual patient's liver function and overall clinical picture.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical attention can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and angioedema.

Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Cardiovascular events, including myocardial infarction and stroke, have also been associated with the use of ibuprofen.

Liver enzyme elevations have been observed in some patients during postmarketing surveillance. Furthermore, serious skin reactions, including exfoliative dermatitis and erythema multiforme, have been documented in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if any of the following conditions apply to the child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

Additionally, patients should be instructed to ask a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Patients should be informed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also seek medical attention if the child shows symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise, a healthcare provider should be contacted.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or damage. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but it should not be administered more than four times a day.

Clinicians should counsel patients to keep the medication out of reach of children. 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.

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.