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Foster and Thrive 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 2024
Label revision date
October 22, 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 2024
Label revision date
October 22, 2025
Manufacturer
Strategic Sourcing Services LLC
Registration number
ANDA075217
NDC root
70677-1146
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 designed for infants aged 6 months to 23 months, available in a concentrated oral suspension with a pleasant berry flavor. It serves 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 non-staining, dye-free, and gluten-free formulation provides relief that can last up to 8 hours.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by reducing inflammation and lowering fever, making it a useful option for parents seeking to comfort their little ones during times of discomfort.

Uses

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

Feel free to take it when you're feeling under the weather, as it can help make you more comfortable during those times.

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 exceed the amount directed. To prepare the medication, shake the bottle well before use.

To find the right dose for your child, refer to the dosing chart based on their weight. If possible, use your child's weight for dosing; if not, you can use their age. For example, if your child weighs between 12-17 pounds and is 6-11 months old, the dose is 1.25 mL. For children weighing 18-23 pounds and aged 12-23 months, the dose is 1.875 mL. Always measure the dose using the dosing device provided, as other devices may not be accurate. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6-8 hours, but do not give more than four doses in a single day.

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 safety by following these guidelines closely. If you have any concerns or questions about your child's health or 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. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, 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 talk to a healthcare professional before giving ibuprofen 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, 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 issues, 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

While the information provided does not include specific warnings or precautions about using ibuprofen during pregnancy, it is important to approach any medication with caution. The insert does not indicate whether ibuprofen is contraindicated (not recommended) for pregnant individuals or if there are any risks to the developing fetus.

Since there are no dosage modifications or special precautions mentioned for pregnant individuals, it is always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children between 6 months and 2 years, the dosage depends on their weight: if your child weighs under 6 pounds, consult a doctor; for those weighing 12-17 pounds, the dose is 1.25 mL, and for 18-23 pounds, it's 1.875 mL.

Always consult a doctor if your child has a history of stomach issues, has not been drinking fluids, or has lost a lot of fluid from vomiting or diarrhea. It's also important to check with a doctor if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic (a medication that helps remove excess fluid). If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using the medication and consult a doctor. Lastly, make sure to keep this medication out of reach of children.

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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential issues, ensuring that the treatment is safe and effective.

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 your dosage or monitoring are necessary. Always prioritize your health by discussing any concerns 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 may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This is especially crucial if you also have other health issues like high blood pressure, heart disease, or kidney disease.

Always communicate openly with your doctor about your liver condition and any other medical history, as this will help ensure you receive the safest and most effective 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. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment is safe and effective. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance 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. Additionally, before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and ensure your safety.

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 used for?

Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for children?

For children aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL. For children aged 12-23 months weighing 18-23 lbs, the dose is 1.875 mL.

How often can I give Ibuprofen to my child?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

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 I use Ibuprofen if my child is under 3 years old?

Do not use Ibuprofen in children under 3 years of age unless directed by a doctor.

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 improve, stop use and consult a doctor immediately.

Is it safe to use Ibuprofen during pregnancy?

The provided information does not mention specific risks or contraindications for using Ibuprofen during pregnancy.

What should nursing mothers know about Ibuprofen?

Nursing mothers should consult a doctor before using Ibuprofen, as it may be excreted in breast milk and its effects on nursing infants are not well studied.

How should I store Ibuprofen?

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 Foster and Thrive Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Foster and Thrive Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Foster and Thrive 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 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, weight should be used to determine the dose; 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.

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

Dosing Chart:

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

  • For children weighing 12-17 lbs and aged 6-11 months, the recommended dose is 1.25 mL.

  • For children weighing 18-23 lbs and aged 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 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, naproxen, or others). Additionally, exceeding the recommended dosage or duration of use may further elevate this risk.

NSAIDs, excluding aspirin, are known to increase the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The 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 the medication for more than two days or administering it to children under three years of age unless directed by a healthcare provider.

Patients should be instructed to discontinue use and seek medical advice 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 suggestive 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.

In cases of overdose, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay (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 risk of severe stomach bleeding. This risk 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. Patients are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of gastrointestinal complications.

Additionally, NSAIDs, excluding aspirin, are associated with 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 guidelines.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. It is recommended that ibuprofen not be used for more than two days in cases of sore throat or in children under three years of age unless directed by a healthcare provider.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Special caution is advised for patients with asthma or those taking diuretics. Additionally, patients under a doctor's care for any serious condition or those taking other medications should seek guidance from a healthcare professional prior to use.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Foster and Thrive Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, infants weighing under 6 months should consult a doctor. For those aged 6 to 11 months and weighing between 12-17 lbs, the recommended dose is 1.25 mL. For children aged 12 to 23 months and weighing between 18-23 lbs, the recommended dose is 1.875 mL.

Healthcare professionals should be consulted if the pediatric patient has a history of stomach problems, such as heartburn, or if they have not been drinking fluids or have experienced significant fluid loss due to vomiting or diarrhea. Additional caution is advised for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, consultation with a doctor is also recommended.

Parents and caregivers should discontinue use and seek medical advice if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than 3 days. It is important to keep this medication out of reach of children.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of ibuprofen during pregnancy. The prescribing information does not indicate whether ibuprofen is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for women of childbearing potential are included in the provided information. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the benefits against any potential risks.

Lactation

Nursing 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. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

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

Patients with significant hepatic impairment should be approached with caution, and the potential benefits of treatment must be weighed against the risks associated with their underlying liver condition.

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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

No specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.

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 crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of stopping the medication and seeking medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be informed to stop use and consult a doctor 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 affected area, or if any new symptoms arise.

When administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. It is advisable for patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning is applicable.

Patients should be encouraged to seek medical advice 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. Additionally, healthcare providers should recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Lastly, patients should be advised to discuss with a doctor or pharmacist before use if the child is taking a diuretic, is under medical care for any serious condition, or is currently taking any other medications.

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, ensuring that only intact and properly labeled items are utilized.

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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Foster and Thrive 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 Foster and Thrive 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.