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Good Neighbor Pharmacy 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)
Marketed in the U.S.
Since 2019
Label revision date
August 28, 2025
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
Marketed in the U.S.
Since 2019
Label revision date
August 28, 2025
Manufacturer
Amerisource Bergen
Registration number
ANDA076359
NDC root
46122-617

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Drug Overview

Ibuprofen is a pain reliever and fever reducer that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is available in chewable tablets of 100 mg, specifically designed for children aged 2 to 11. This medication helps reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, sore throat, headaches, and toothaches.

When taken, ibuprofen can provide relief for up to 8 hours, making it a convenient option for managing discomfort. The chewable tablets are orange-flavored, making them easier for children to take.

Uses

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

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

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, as this product does not provide complete warnings for adult use. Always check the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age instead.

For children under 24 pounds or under 2 years old, it's best to consult a doctor before giving this medication. For those weighing between 24 to 35 pounds (ages 2-3 years), the recommended dose is 1 tablet. If your child weighs between 36 to 47 pounds (ages 4-5 years), they should take 1 ½ tablets. For children weighing 48 to 59 pounds (ages 6-8 years), the dose is 2 tablets, and for those weighing 60 to 71 pounds (ages 9-10 years), it's 2 ½ tablets. Finally, if your child weighs 72 to 95 pounds (age 11 years), they should take 3 tablets.

If you need to give another dose, you can repeat it every 6 to 8 hours, but do not exceed 4 doses in a single day. Always ensure you do not give more than the directed amount.

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, 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, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

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

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy may pose risks to your baby, including potential heart problems and kidney issues.

If you need pain relief or anti-inflammatory treatment while pregnant, consult your healthcare provider for safer alternatives and to discuss any necessary dosage adjustments. Always avoid using ibuprofen unless your doctor specifically advises it. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

This product is suitable for children aged 2 to 11 years. When giving it to your child, it's important to follow the dosing chart based on their weight. For example, if your child weighs between 24-35 pounds (ages 2-3), you can give them 1 tablet. As their weight increases, the dosage also increases, with a maximum of 3 tablets for an 11-year-old weighing 72-95 pounds.

Be cautious if your child has a sore throat; do not use this product for more than 2 days or for children under 3 years without consulting a doctor. Always check with a healthcare professional before use if your child has a history of stomach issues, dehydration, or other serious health conditions. If you notice any signs of stomach bleeding, heart problems, or if your child does not improve within 24 hours, stop use and seek medical advice immediately.

Geriatric Use

When it comes to using this medication in older adults, there are no specific recommendations or considerations outlined in the drug insert. This means that the standard guidelines apply, and healthcare providers will typically assess your individual health needs and conditions before prescribing it.

It's always important to discuss any concerns you may have with your doctor, especially if you or a loved one is an older adult. They can provide personalized advice and ensure that the medication is safe and appropriate for your situation.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of severe stomach bleeding increases. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can also heighten this risk.

Before giving ibuprofen to your child, make sure to consult with a healthcare provider, especially if they are taking any other medications. This conversation is crucial to ensure their safety and to avoid any potentially harmful interactions.

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

You may experience some burning in your mouth or throat when taking this medication. To help reduce this discomfort, it's recommended to take it with food or water. If you notice any stomach upset, consider taking the medication with food or milk to alleviate the issue.

FAQ

What is ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that helps reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use ibuprofen?

Ibuprofen is indicated for children aged 2 to 11 years.

How should ibuprofen chewable tablets be taken?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for ibuprofen?

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 has an allergic reaction to ibuprofen?

If your child experiences symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop use and seek medical help immediately.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe stomach bleeding, increase the risk of heart attack and stroke, and should not be used if your child has had an allergic reaction to it or other pain relievers.

Can ibuprofen be used during pregnancy?

Ibuprofen is contraindicated in pregnancy, especially during the third trimester, due to potential risks to the fetus.

What should I do if my child does not get relief from ibuprofen?

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

How should ibuprofen be stored?

Store ibuprofen 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 Good Neighbor Pharmacy Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Neighbor Pharmacy Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

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 specific directions or complete warnings for adult use. Healthcare professionals should 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, it is advised to consult a doctor.

  • 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.

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 elicit 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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are 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 recommended dosage or for prolonged periods.

Patients should seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. It is advised not to use the product for more than two days or in children under three years of age without medical guidance.

Common adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. If stomach upset occurs, taking the medication with food or milk is recommended.

Patients are advised to consult a healthcare professional before use if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important to inform the healthcare provider if the patient is under medical care for any serious condition or is taking other medications.

In the event that symptoms do not improve within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients should seek medical advice. Redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare professional.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In pediatric populations, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Therefore, it is imperative to monitor for signs of bleeding in children receiving these combinations.

Additionally, the risk of severe stomach bleeding is elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Healthcare providers are advised to consult with a physician prior to administering ibuprofen if the child is currently taking any other medications. This precaution is essential to ensure patient safety and to mitigate the risk of adverse interactions.

Packaging & NDC

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

Packaging configurations for Good Neighbor Pharmacy Childrens Ibuprofen.
Details

Pediatric Use

This product is indicated for pediatric patients aged 2 to 11 years. The dosing recommendations are as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet; for 36-47 lb (ages 4-5 years), 1 ½ tablets; for 48-59 lb (ages 6-8 years), 2 tablets; for 60-71 lb (ages 9-10 years), 2 ½ tablets; and for 72-95 lb (age 11 years), 3 tablets.

Caution is advised regarding sore throat symptoms; the product should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor. It is contraindicated in children with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer.

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. Additional caution is warranted if the child has not been drinking fluids, has lost significant fluid due to vomiting or diarrhea, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. The use of diuretics in the child also necessitates consultation with a healthcare provider.

Parents should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling), does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the painful area, or develops any new symptoms.

Geriatric Use

Elderly patients may not have specific recommendations or considerations outlined in the prescribing information for this medication. Therefore, healthcare providers should exercise caution when prescribing this drug to geriatric patients, particularly those aged 65 and older.

It is advisable to monitor these patients closely for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, healthcare providers should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of this medication for elderly patients.

Due to the absence of specific dosage adjustments or safety considerations for this population, careful clinical judgment is essential in managing treatment for geriatric patients.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, such as potential cardiovascular complications and renal impairment. Pregnant patients are advised to avoid ibuprofen unless specifically directed by a healthcare professional. If the use of ibuprofen is deemed necessary, healthcare providers should be consulted for appropriate alternatives and dosage adjustments to mitigate potential risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

In patients with significant hepatic impairment, such as those with a history of liver cirrhosis, the use of this medication may be restricted or contraindicated, depending on the severity of the impairment and the specific clinical scenario. It is essential for healthcare providers to weigh the benefits against the risks when considering treatment options for these patients.

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 healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic effects were observed in the studies conducted. Additionally, there were no reported non-teratogenic effects. The available data did not provide any specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 important to inform patients that mouth or throat burning may occur, and to recommend administering the medication with food or water to mitigate this effect.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. Healthcare providers should emphasize the necessity of consulting a doctor before use if the patient has a child with a history of stomach problems, such as heartburn, or if there are concerns regarding stomach bleeding.

Additionally, healthcare providers should encourage patients to discuss any history of serious side effects from pain relievers or fever reducers, as well as any issues related to fluid intake. It is crucial to ask about recent fluid loss due to vomiting or diarrhea, and to consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke.

Patients should also be advised to consult a doctor if the child has asthma or is taking a diuretic. Furthermore, it is important to recommend that patients speak with 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 contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

Patients may experience mouth or throat burning when taking the medication; therefore, it is advised to administer it with food or water. In cases where stomach upset occurs, taking the medication with food or milk is recommended. No further information is available regarding laboratory tests, abuse potential, route, method, frequency of administration, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy 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 Good Neighbor Pharmacy 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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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.