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Childrens Ibuprofen 100

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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
Walgreen Company
Registration number
ANDA076359
NDC root
0363-1521
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

Children’s Ibuprofen 100 is a chewable tablet that contains 100 mg of ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed to help relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, it works to reduce fever, providing comfort when your child is feeling unwell.

This medication is recommended for children aged 2 to 11 years and can last up to 8 hours. The tablets come in a pleasant grape flavor, making them easier for kids to take. Each package contains 24 chewable tablets, and it is comparable to the active ingredient found in Children’s Motrin®.

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 taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. You can find the right dose based on your weight or age using the dosing chart provided. If you need to take another dose, you can do so every 6 to 8 hours, but remember not to use the medication 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, they should take 1 ½ tablets. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 2 tablets. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, they should take 2 ½ tablets, and 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

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

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and 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 severe stomach pain, or if they show signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. Always 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, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

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

If you or your child have a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always stop use and consult your doctor if symptoms worsen or new symptoms appear.

Overdose

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

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

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any risks or contraindications associated with its use. There are also no dosage modifications recommended for pregnant individuals, and no special precautions are outlined in the insert.

However, since there is no specific guidance provided, it's always best to consult with your healthcare provider before taking any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding and considering using this product, it’s important to consult your doctor first. There is a possibility that ibuprofen may pass into your breast milk, and the effects on your nursing infant 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 adverse effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

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. For example, children weighing between 24-35 pounds (2-3 years) should take 1 tablet, while those weighing 72-95 pounds (11 years) can take 3 tablets. Always consult a doctor if your child has a history of stomach issues, has not been drinking enough fluids, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

If your child is taking a diuretic (a medication that helps remove excess fluid from the body), it's also important to check with a doctor. 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. Remember 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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always prioritize open communication with your healthcare team to ensure safe and effective treatment, especially as age can affect how medications work in the body.

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 may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize your health and communicate openly with your doctor about your medical history.

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.

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 your overall treatment plan is safe and effective. Always share your complete list of medications and any health conditions you have, as this information is crucial for your safety and well-being.

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 temperature range helps maintain its effectiveness.

When handling the product, be sure to 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 compromise its safety and effectiveness. Always prioritize these guidelines to ensure safe and proper use.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent any burning sensation in your mouth or throat, consider taking the medication with food or water. If you experience an upset stomach, taking it with food or milk may also help.

FAQ

What is Children's Ibuprofen 100?

Children's Ibuprofen 100 is a pain reliever and fever reducer in the form of chewable tablets containing 100 mg of ibuprofen.

What age group is Children's Ibuprofen 100 recommended for?

It is recommended for children aged 2 to 11 years.

How long does the effect of Children's Ibuprofen 100 last?

The effects can last up to 8 hours.

How should I administer Children's Ibuprofen 100?

You should chew or crush the tablets completely before swallowing.

What are the indications for using Children's Ibuprofen 100?

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

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

Do not use Children's Ibuprofen 100 if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What are the dosing instructions for Children's Ibuprofen 100?

Dosing is based on weight and age; for example, children weighing 24-35 lbs (ages 2-3) should take 1 tablet.

What should I do if my child experiences severe symptoms?

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

Is it safe to use Children's Ibuprofen 100 during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy.

Can nursing mothers use Children's Ibuprofen 100?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do if the printed seal under the cap is broken?

Do not use the product if the printed seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Childrens Ibuprofen 100 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 100.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 100, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

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

Dosing should be determined using the chart provided below. When possible, weight should be used to determine the appropriate dose; 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 a total of 4 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.

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 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 carries a 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 using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

NSAIDs, with the exception of 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 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 not to use ibuprofen for more than two days or to administer it to children under three years of age without medical guidance.

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

Patients should be advised to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms 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.

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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than directed.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical 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. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice. Additionally, patients with asthma or those taking diuretics should consult a healthcare professional prior to use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen 100 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 100.
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: Consult 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 significant 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.

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 adverse effects or changes in therapeutic response, 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 mention any contraindications or risks associated with ibuprofen use in this population. 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

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of ibuprofen 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, 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 options. Regular follow-up assessments are advised to monitor for any changes in liver function that may necessitate further dosage modifications or discontinuation of therapy.

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, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious adverse events reported include gastrointestinal bleeding, renal impairment, and cardiovascular events. Furthermore, the risk of serious adverse reactions may increase with prolonged use or higher doses of the medication.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed 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 stomach pain that does not improve. Additionally, 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 leg swelling, they should stop use and seek medical attention.

It is important to communicate that 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 three days, the patient should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Patients should be made aware that while using this product, mouth or throat burning may occur; therefore, it is advisable 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 any of the following apply: the stomach bleeding warning is relevant to the child, the child has a history of stomach issues such as heartburn, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids 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 a diuretic.

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

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 compromise of the product. Proper handling and storage conditions are essential to ensure the safety and effectiveness of the product.

Additional Clinical Information

The medication is administered orally, with tablets required to be chewed or crushed completely before swallowing. Dosing may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients that mouth or throat burning may occur, and it is advisable to take the medication with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is recommended. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 100, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen 100, 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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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.