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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 26, 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 26, 2025
Manufacturer
Walgreen Company
Registration number
ANDA076359
NDC root
0363-1461
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Children’s Ibuprofen 100 is a chewable tablet that contains 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication is designed for children aged 2 to 11 years and is commonly used to reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headaches, and toothaches.

The effects of Children’s Ibuprofen 100 can last up to 8 hours, providing effective relief when your child needs it. The tablets come in a pleasant orange flavor, making them easier for children to take.

Uses

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

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

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. You can find the right dose based on your child's weight or age, and if you're unsure, it's best to consult a doctor, especially for children under 2 years old.

If 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 reference, here’s a quick guide to the appropriate dosage: for children weighing under 24 pounds or under 2 years old, consult a doctor. For those weighing 24-35 pounds (2-3 years), give 1 tablet; for 36-47 pounds (4-5 years), give 1 ½ tablets; for 48-59 pounds (6-8 years), give 2 tablets; for 60-71 pounds (9-10 years), give 2 ½ tablets; and for 72-95 pounds (11 years), give 3 tablets. Always ensure you are following these guidelines to keep your child safe.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or shows 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

It's important to be aware of some serious warnings when using this medication. If you or your child have a known allergy to aspirin, be cautious, as this medication can cause severe allergic reactions, including hives, swelling, and difficulty breathing. If any of these symptoms occur, stop using the medication and seek medical help immediately. Additionally, this medication can increase the risk of stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or ibuprofen.

You should also be mindful of the risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by a high fever, headache, nausea, or vomiting, consult a doctor right away. Before using this medication, it's wise to talk to a doctor if your child has any history of stomach issues, dehydration, or serious health conditions like high blood pressure or asthma.

If you suspect an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222. Stop using the medication and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness), or if their condition does not improve within 24 hours. Always seek medical advice if new symptoms arise or if fever or pain worsens or lasts more than three days.

Overdose

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

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

Pregnancy Use

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals. 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, you can feel reassured that there are no specific warnings or recommendations against using ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 under 24 pounds should have their dosage determined by a doctor, while those weighing 24-35 pounds can take 1 tablet, and the dosage increases with weight up to 3 tablets for those weighing 72-95 pounds.

It's important to consult a doctor if your child has any history of stomach issues, such as heartburn, or if they have not been drinking enough fluids due to vomiting or diarrhea. Additionally, if your child has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic, you should seek medical advice before use. Always keep this medication out of reach of children, and stop use immediately if your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice. They can help determine if this medication is appropriate for you or your loved one, considering any unique health needs or potential risks.

Always discuss any existing health conditions or medications with your doctor, as they can provide guidance on safety and effectiveness tailored to older adults. Your healthcare provider may also suggest monitoring for any side effects or changes in health while using this medication.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments to the dosage or monitoring are necessary based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current 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 (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

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 everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

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.

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 indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen 100 used for?

Children's Ibuprofen 100 is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

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

This medication is suitable for children aged 2 to 11 years.

How should I administer Children's Ibuprofen 100?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for Children's Ibuprofen 100?

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

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 get better.

Are there any allergies associated with Children's Ibuprofen 100?

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

Can I give Children's Ibuprofen 100 to my child if they have had an allergic reaction to pain relievers?

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

What should I do if my child does not get relief from pain or fever?

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

Is there any specific storage requirement for Children's Ibuprofen 100?

Store the product 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 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, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed a total of 4 doses in a 24-hour period.

Dosing Chart:

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

  • For patients weighing 24-35 lb or aged 2-3 years, administer 1 tablet.

  • For patients weighing 36-47 lb or aged 4-5 years, administer 1 ½ tablets.

  • For patients weighing 48-59 lb or aged 6-8 years, administer 2 tablets.

  • For patients weighing 60-71 lb or aged 9-10 years, administer 2 ½ tablets.

  • For patients weighing 72-95 lb or aged 11 years, administer 3 tablets.

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

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery and cardiovascular stability.

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 carries 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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with 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 unless directed by a physician.

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 problems (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, 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 contact should be made with a Poison Control Center 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, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

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 carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use.

Additionally, ibuprofen is associated with 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 directed dosage or for prolonged periods.

Common adverse reactions may include gastrointestinal symptoms, and patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

Patients are advised to consult a healthcare professional if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using ibuprofen, it is recommended that patients seek medical advice if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Special caution is advised for patients with asthma or those taking diuretics. Furthermore, consultation with a healthcare provider is essential for patients under medical care for serious conditions or those taking other medications.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 product unless directed by a doctor. For dosing, the following guidelines apply:

  • 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. It is also important to consult a doctor if the child is taking a diuretic.

Parents should be instructed to stop use and seek medical advice if the child exhibits any signs of stomach bleeding or symptoms indicative of heart problems or stroke. The product should be kept out of reach of children.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

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, nor does the insert include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

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

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 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 potential 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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 several adverse reactions associated with the use of the product. Reports indicate the occurrence of allergic reactions, which may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, stomach bleeding has 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).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Cases of renal toxicity, including acute kidney injury, have been documented, especially in patients with pre-existing renal impairment or dehydration.

Furthermore, liver enzyme elevations have been observed in the postmarketing experience. Reports of gastrointestinal adverse events, including perforation and ulceration, have been received, particularly in individuals with a history of gastrointestinal issues.

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 essential to inquire whether the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, as this may contraindicate the use of the medication.

Providers should also discuss the importance of avoiding the medication if the child has undergone heart surgery recently. Patients should be informed to monitor for signs of stomach bleeding, which may include faintness, vomiting blood, bloody or black stools, or persistent stomach pain. If any of these symptoms occur, medical attention should be sought promptly.

Additionally, healthcare providers should assess for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. 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, further evaluation is warranted.

Patients should be counseled to report any redness or swelling in the painful area or the emergence of new symptoms. It is advisable to inform patients that mouth or throat burning may occur and that the medication should be administered with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is recommended.

Providers should emphasize the warning regarding stomach bleeding, particularly for children with a history of stomach issues such as heartburn, or those who have experienced serious side effects from pain relievers or fever reducers. It is crucial to ensure that the child is adequately hydrated, especially if they have lost fluids due to vomiting or diarrhea.

Healthcare providers should also consider the child's medical history, including any conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Special attention should be given to children with asthma or those taking diuretics. Lastly, it is important to confirm whether the child is under a physician's care for any serious condition or is taking any other medications, as these factors may influence the safety and efficacy of the treatment.

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 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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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.