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Care One 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 2006
Label revision date
November 20, 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 2006
Label revision date
November 20, 2025
Manufacturer
American Sales Company
Registration number
ANDA075217
NDC root
41520-255
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

CAREone® is an infants’ ibuprofen oral suspension that contains 50 mg of ibuprofen per 1.25 mL. It is a nonsteroidal anti-inflammatory drug (NSAID) that helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. This medication is specifically designed for infants aged 6 to 23 months and comes in a concentrated, dye-free formula with a pleasant berry flavor.

You can expect CAREone® to provide relief for up to 8 hours, making it a convenient option for managing your child's discomfort. It is important to use the enclosed syringe for accurate dosing.

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.

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 complete 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 their weight for dosing; if not, you can use their 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, dispense 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 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

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 this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

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 fatal, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, 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 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, or if you experience chest pain, trouble breathing, or weakness, 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 are under three years old. 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 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 reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach the use of any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy. They can provide personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen may pass into breast milk, which could pose a potential risk to your infant. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding any medications you plan to take while nursing.

Pediatric Use

It's important to be cautious when using this medication for children. You should avoid giving it to children under 3 years old unless a doctor specifically advises you to do so. For infants under 6 months, always consult a doctor before use. If your child is between 6 to 23 months, follow the dosing guidelines carefully: for those weighing 12-17 pounds (6-11 months), the dose is 1.25 mL, and for those weighing 18-23 pounds (12-23 months), the dose is 1.875 mL.

Make sure not to exceed 4 doses in a single day. If your child's symptoms do not improve within 24 hours, or if they have a fever or pain lasting more than 3 days, it's essential to consult a doctor. Additionally, keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately. Always consult a healthcare professional if your child has a history of stomach issues, is taking other medications, or is not drinking enough fluids.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help determine the best approach for you, considering factors like your overall health and any other medications you may be taking.

If you or a loved one is an older adult, make sure to monitor for any unusual side effects or changes in health after starting a new medication, and don’t hesitate to reach out to your doctor with any questions or concerns.

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 are needed based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current health conditions.

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 crucial to ensure that the medication is safe and effective for you.

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 to receive the best care possible.

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 best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before using, check that the printed neckband is intact; do not use the product 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 quality and effectiveness of your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is CAREone®?

CAREone® is an infants’ ibuprofen oral suspension that contains 50 mg of ibuprofen per 1.25 mL.

What does CAREone® do?

It acts as a pain reliever and fever reducer, helping to reduce fever and relieve minor aches and pains due to conditions like the common cold, flu, sore throat, headaches, and toothaches.

What age group is CAREone® suitable for?

CAREone® is intended for infants aged 6 to 23 months.

How should I measure the dose of CAREone®?

Use the enclosed syringe to measure the dose accurately; do not use any other device.

What is the dosing chart for CAREone®?

For infants 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.

What should I do if my child has a history of stomach problems?

Consult a doctor before using CAREone® if your child has a history of stomach problems, such as ulcers or bleeding.

What are the warnings associated with CAREone®?

Warnings include the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke. Consult a doctor if your child experiences severe symptoms.

Can I use CAREone® if my child is allergic to ibuprofen?

No, do not use CAREone® if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do in case of an overdose?

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

Is CAREone® safe to use during pregnancy?

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy.

Can nursing mothers use CAREone®?

Nursing mothers should consult a doctor before using CAREone® due to the potential for ibuprofen to be excreted in breast milk.

Packaging Info

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

Packaging configurations for Care One Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Care One 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 should be determined using the dosing chart provided below. When possible, weight should be used to calculate the dose; if weight is not available, age may be used as a substitute.

Dosing should be measured using the dosing device provided; no other measuring device should be utilized to ensure accuracy. 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 months, consult a doctor before administration.

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

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

Contraindications

Use is contraindicated in patients who have 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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 such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an increased 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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, medical consultation is necessary. Any emergence of new symptoms should also prompt a discussion with a healthcare provider.

In the event of an overdose, it is crucial to seek 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, some of which can be serious.

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this 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 may increase this risk.

There is also a significant warning regarding 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 higher doses or for extended periods.

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 advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's direction.

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 provider. Similarly, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients are advised to consult a healthcare professional before using ibuprofen if they have a history of stomach issues, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, those under a doctor's care for serious conditions or taking other medications should seek guidance prior to use.

It is important for patients to monitor their symptoms closely; 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 contact their healthcare provider. Redness or swelling in the affected area or the emergence of new symptoms should also prompt a consultation.

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 Care One Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Care One Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For infants under 6 months, consultation with a doctor is advised prior to use.

Dosing for pediatric patients is as follows: for those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; for those weighing 18-23 lbs (12-23 months), the recommended dose is 1.875 mL. It is important not to exceed 4 doses in a 24-hour period.

Healthcare professionals should be consulted if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated. If symptoms do not improve within 24 hours, or if fever or pain persists for more than 3 days, a doctor should be contacted.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. 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 text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

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, or liver cirrhosis, as these 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.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic strategies. Regular follow-up assessments are advised to monitor any changes in liver function that may impact treatment decisions.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

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. These include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis. Additionally, reports of serious skin reactions have been received, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

There have also been cases of cardiovascular events, such as myocardial infarction and stroke, noted in association with ibuprofen use. Furthermore, liver enzyme elevations have been documented in the postmarketing data. Lastly, instances of asthma exacerbations have been reported in patients with a prior history of asthma.

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 product 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 use 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). Care must be taken to ensure that the product is not frozen, as freezing may compromise its integrity. Additionally, the product should not be used if the printed neckband is broken or missing, as this may indicate tampering or damage. Proper handling and storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if they experience stomach upset. In the event of an overdose, patients are instructed to seek medical assistance immediately or contact a Poison Control Center 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 Care One 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 Care One 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.