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Up and up Childrens Ibuprofen

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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 2019
Label revision date
October 28, 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 2019
Label revision date
October 28, 2025
Manufacturer
Target Corporation
Registration number
ANDA076359
NDC root
11673-741
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Children’s Ibuprofen Chewable Tablets are a pain reliever and fever reducer designed for children aged 2 to 11 years. Each tablet contains 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). These chewable tablets come in a pleasant grape flavor and can help reduce fever as well as relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The effects of Children’s Ibuprofen can last up to 8 hours, providing your child with relief when they need it most. It's important to ensure that the tablets are chewed or crushed completely before swallowing for the best results.

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

When 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. To find the right dose, refer to the dosing chart based on your child's weight or age. If you need to give another dose, you can do so every 6 to 8 hours, but remember not to use it more than four times in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving any tablets. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, you can give them 1 and a half tablets. For children aged 6 to 8 years who weigh between 48 and 59 pounds, the dose is 2 tablets. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, you can give them 2 and a half tablets. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 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 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

Using ibuprofen can lead to some serious side effects, so it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or use other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal, especially if taken in higher doses or for longer than recommended. 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, seek medical attention immediately. Always consult a doctor if you have any underlying health conditions or are taking other medications before using ibuprofen.

Warnings and Precautions

You should be aware of some important warnings and precautions when using ibuprofen. First, if you or your child has a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If any of these occur, stop using the medication and seek medical help immediately.

Ibuprofen can also lead to serious stomach bleeding, especially if your child has a history of stomach ulcers or is taking other medications like blood thinners or steroids. Additionally, using ibuprofen increases the risk of heart attack and stroke, particularly if taken in higher doses or for longer than recommended. If your child has a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor right away.

Before using ibuprofen, consult a doctor if your child has any history of stomach issues, dehydration, high blood pressure, heart disease, liver or kidney problems, or asthma. If your child experiences symptoms like faintness, vomiting blood, or severe stomach pain, stop the medication and call your doctor. For any signs of heart problems or stroke, such as chest pain or trouble breathing, seek emergency help immediately. If there’s no relief within 24 hours, or if symptoms worsen or new ones appear, contact your doctor. In case of an overdose, get medical help or contact a Poison Control Center at 1-800-222-1222.

Overdose

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

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

Pregnancy Use

When it comes to using ibuprofen during pregnancy, the available information does not provide specific guidance. There are no stated risks or contraindications for pregnant individuals, and the insert does not mention any necessary dosage adjustments or special precautions.

However, since the safety of any medication during pregnancy can vary based on individual circumstances, it’s always best to consult with your healthcare provider before taking ibuprofen or any other medication while pregnant. They can help you make informed decisions that prioritize your health and the health of 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 avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing under 24 pounds or under 2 years should consult a doctor, while those weighing 24-35 pounds (ages 2-3) can take 1 tablet, and the dosage increases with weight and age up to 3 tablets for an 11-year-old weighing 72-95 pounds.

It's important to consult a doctor if your child has any history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are 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 seek medical advice. Always keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you 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 in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety.

Before using the product, 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. Always handle the product with care to ensure your safety and the product's integrity.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen Chewable Tablets used for?

Children's Ibuprofen Chewable Tablets are 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's Ibuprofen Chewable Tablets?

The dosage depends on the child's weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 1 tablet.

How should I administer Children's Ibuprofen Chewable Tablets?

You should chew or crush the tablets completely before swallowing.

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

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

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Children's Ibuprofen if my child has asthma?

Consult a doctor before use if your child has asthma or any other serious condition.

Is it safe to use Children's Ibuprofen during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy, so consult a doctor.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

How should I store Children's Ibuprofen Chewable Tablets?

Store the tablets between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Up and up Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Up and up Childrens 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

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, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative. If necessary, doses may be repeated every 6 to 8 hours, but it is important not to exceed four doses in a 24-hour period.

Dosing Chart:

  • For patients weighing less than 24 lb or under 2 years of age: Tablets - consult a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years: Tablets - 1.

  • For patients weighing 36-47 lb or aged 4-5 years: Tablets - 1 ½.

  • For patients weighing 48-59 lb or aged 6-8 years: Tablets - 2.

  • For patients weighing 60-71 lb or aged 9-10 years: Tablets - 2 ½.

  • For patients weighing 72-95 lb or aged 11 years: Tablets - 3.

It is essential to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use is contraindicated in children 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 of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Additionally, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

Before administering ibuprofen, it is advisable to consult a healthcare professional if any of the following conditions apply: the child has a history of stomach issues, such as heartburn; has experienced adverse effects from pain relievers or fever reducers; is dehydrated due to vomiting or diarrhea; has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke; has asthma; or is taking diuretics. Furthermore, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

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

Parents and caregivers should discontinue use and contact a healthcare provider 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 advice should be sought. Any new symptoms that arise should also prompt a consultation with a healthcare professional.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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 is associated with an increased risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin and naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been 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 duration.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical consultation is advised. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if a child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, a healthcare provider should be consulted.

Mild adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. It is recommended to take ibuprofen with food or milk if stomach upset occurs.

Before using ibuprofen, it is essential to consult a healthcare professional if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, consultation is advised if the child is under a doctor's care for any serious condition or is taking other medications.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Up and up Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age as follows:

  • Under 24 lb / Under 2 years: Ask a doctor

  • 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

  • 72-95 lb / 11 years: 3 tablets

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been drinking fluids or has lost a significant amount of fluid 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, or asthma. If the child is taking a diuretic, a doctor should also be consulted.

Parents should be instructed to stop 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 essential to keep this medication out of reach of children, and in the event of an overdose, immediate medical help or contact with a Poison Control Center is necessary.

Geriatric Use

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

Pregnancy

There is no specific information available regarding the use of ibuprofen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of ibuprofen in pregnant individuals. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of 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, 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 medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach and monitoring requirements.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: gastrointestinal bleeding, renal impairment, and liver enzyme elevations. These events have been documented in the context of routine pharmacovigilance activities.

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, they should stop use and seek 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.

It is important to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Patients should also be advised to seek medical attention if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients may experience mouth or throat burning; therefore, it is recommended to administer it with food or water. If stomach upset occurs, taking the medication with food or milk may help alleviate discomfort. Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child or if there is a history of stomach problems, such as heartburn.

Patients should also be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, it is essential to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Patients should also be reminded to inform their healthcare provider if the child is taking a diuretic or is under medical care for any serious condition, as well as to discuss any other medications the child may be taking.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. 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 indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Up and up 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 Up and up 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.

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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.