Symptom checker
Select audience type

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

ADD CONDITION

items per page

Childrens Ibuprofen

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2020
Label revision date
July 22, 2025
Manufacturer
Publix Super Markets Inc
Registration number
ANDA076359
NDC root
56062-801
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 chewable tablet medication designed for children ages 2 to 11, available in a pleasant orange flavor. It serves as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). You can use ibuprofen to help reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing relief that can last up to 8 hours. Each package contains 24 chewable tablets, which should be chewed or crushed completely before swallowing for effective use.

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 taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. You can find the right dose based on your child's weight or age, and if you're unsure, it's best to consult a doctor, especially for children under 2 years old.

If your child needs another dose, you can repeat it every 6 to 8 hours, but remember not to use this medication more than four times in a single day. For reference, here’s a quick guide: for children weighing under 24 pounds or under 2 years old, consult a doctor. For those weighing 24-35 pounds (ages 2-3), give 1 tablet; for 36-47 pounds (ages 4-5), give 1 ½ tablets; for 48-59 pounds (ages 6-8), give 2 tablets; for 60-71 pounds (ages 9-10), give 2 ½ tablets; and for 72-95 pounds (age 11), give 3 tablets. Always ensure you are following these guidelines to keep your child safe and healthy.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

You should be aware of some potential side effects when using this medication. Severe allergic reactions, particularly in individuals allergic to aspirin, can occur and may include symptoms like hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication can increase the risk of severe stomach bleeding, especially if you have a history of stomach ulcers, are taking blood thinners or steroids, or are using other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal, particularly if used in higher doses or for longer than recommended. If you experience a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, it's important to consult a doctor. Be vigilant for signs of stomach bleeding, heart problems, or stroke, and seek medical attention if you notice symptoms like faintness, vomiting blood, chest pain, or weakness on one side of the body. Always use this medication as directed and consult your healthcare provider if you have any concerns.

Warnings and Precautions

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

This medication 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly. Always seek emergency medical help in case of an overdose by contacting a Poison Control Center at 1-800-222-1222. If symptoms worsen or new symptoms appear, or if there is no relief within 24 hours, stop using ibuprofen and consult your doctor.

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 specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the text does not provide any recommendations for dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

You should be cautious when giving this medication to children. It is not recommended for children under 3 years old unless a doctor advises otherwise. For children aged 2 to 11 years, the dosage depends on their weight. For example, a child weighing 24-35 pounds (about 2-3 years old) should take 1 tablet, while a child weighing 72-95 pounds (11 years old) can take 3 tablets. Always consult a doctor if your child has a history of stomach issues, high blood pressure, heart disease, or is taking other medications.

It's important to monitor your child for any serious side effects. If they experience symptoms like stomach pain, fainting, or any signs of bleeding, seek medical help immediately. Additionally, if your child does not feel better within 24 hours or if their fever or pain worsens, contact a healthcare professional. Always use the medication as directed, and do not exceed four doses in a day.

Geriatric Use

When it comes to using Children's Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, generally, elderly patients can use this medication without special considerations or safety concerns related to their age.

However, as with any medication, it's always wise to consult with a healthcare provider before starting treatment, especially if you have any underlying health conditions or are taking other medications. Your healthcare provider can help ensure that this medication is safe and appropriate for your individual needs.

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 healthcare provider can help determine if this medication is safe for you and whether any adjustments to the dosage or monitoring are necessary. Always prioritize your health by discussing your medical history with your doctor.

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 will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

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

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If your child is taking ibuprofen, you should also know that the risk of stomach bleeding increases if they are on blood thinners (medications that prevent blood clots) or steroids. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can further elevate this risk.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or if they are taking any other medications. This conversation is crucial to avoid potential interactions and to keep your child healthy.

Storage and Handling

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

When handling the product, please check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may indicate that it is no longer safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that helps reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use ibuprofen chewable tablets?

Ibuprofen chewable tablets are for children ages 2 to 11.

How should I administer ibuprofen chewable tablets?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for ibuprofen?

Do not use more than 4 times a day and follow the dosing chart based on your child's weight and age.

What should I do if my child experiences signs of stomach bleeding?

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not get better, stop use and consult a doctor immediately.

Are there any serious side effects of ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke.

Can ibuprofen be used during pregnancy?

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy, but consult a doctor for advice.

What should I do if my child does not get relief from ibuprofen?

If your child does not get any relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

Is there a risk of allergic reactions with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, especially in individuals allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

What should I do if my child is taking other medications?

Consult a doctor if your child is taking other medications, especially blood thinners or other NSAIDs, as this may increase the risk of side effects.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each chewable tablet contains 100 mg of ibuprofen and is formulated in an orange flavor for palatability. The dosage form is designed for oral administration, with the recommendation to chew or crush the tablets completely before swallowing. The analgesic effect lasts up to 8 hours. This product is available in a package containing 24 chewable tablets and is comparable to the active ingredient found in Children’s Motrin®.

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

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below. When possible, weight should be used to ascertain the appropriate dose; if weight is not available, age may be utilized as a secondary measure. If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed a maximum of 4 doses in a 24-hour period.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is recommended.

  • For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb and aged 11 years, the recommended dose is 3 tablets.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). It is crucial to adhere strictly to the recommended dosage and duration of use to mitigate this risk.

NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Patients should be advised to consult a physician promptly and to avoid using ibuprofen for more than two days or administering it to children under three years of age unless directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be advised to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing 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; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. 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.

There is a significant risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen. The risk of stomach bleeding is further heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, 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 escalates with prolonged use or higher than directed dosages.

Patients should be vigilant for signs of serious conditions, such as a severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. It is advised not to use the medication for more than two days or to administer it to children under three years of age without a doctor's guidance.

In the event of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, patients should discontinue use and consult a healthcare professional. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Other adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. If stomach upset occurs, it is recommended to take the medication with food or milk. Patients should also be aware that if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may be administered this medication, but it is not recommended for children under 3 years of age unless directed by a physician. Dosing should primarily be based on weight; however, age may be used if weight is not available. The recommended dosages are as follows: for children weighing under 24 lb or under 2 years, consult a doctor; for those weighing 24-35 lb (2-3 years), 1 tablet; 36-47 lb (4-5 years), 1 ½ tablets; 48-59 lb (6-8 years), 2 tablets; 60-71 lb (9-10 years), 2 ½ tablets; and 72-95 lb (11 years), 3 tablets. Doses may be repeated every 6-8 hours, not exceeding 4 doses in a 24-hour period.

Safety concerns must be considered, particularly in children with a history of stomach problems, such as heartburn, as there is a risk of stomach bleeding. Consultation with a doctor is advised if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Additional caution is warranted for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics. It is also important to consult a doctor if the child is under care for any serious condition or is taking other medications.

Parents and caregivers should be vigilant for signs that necessitate discontinuation of use and consultation with a healthcare professional. These signs include symptoms of stomach bleeding (e.g., faintness, vomiting blood, bloody or black stools, persistent stomach pain), heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling), lack of relief within 24 hours, worsening fever or pain lasting more than 3 days, redness or swelling in the affected area, or the emergence of new symptoms.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Children's Ibuprofen. Therefore, healthcare providers may not need to implement any additional precautions or modifications when prescribing this medication to geriatric patients. However, as with any medication, it is advisable to monitor elderly patients for any potential adverse effects or interactions, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined 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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised.

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 therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their hepatic impairment.

It is essential for healthcare providers to weigh the benefits and risks of therapy in this population and to adjust treatment plans accordingly.

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 help 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 teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 ongoing safety monitoring.

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.

Patients should be informed that they may experience burning sensations in the mouth or throat. To mitigate this, it is recommended to take the medication with food or water. Additionally, if patients experience stomach upset, they should take the medication with food or milk to help alleviate discomfort.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored in a controlled environment, maintaining a temperature range between 68-77°F (20-25°C).

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.