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Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
June 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
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 2002
Label revision date
June 10, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA074937
NDC root
41250-660
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

Ibuprofen is a medication commonly used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps reduce fever. This oral suspension is specifically formulated for children ages 2 to 11 years and comes in a pleasant grape flavor.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by blocking certain substances in the body that cause pain and inflammation, providing relief that can last up to 8 hours.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart provided, which is based on weight. If you can't use weight, you can use age as a guide.

When measuring the dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. For children, if the dose is needed again, you can repeat it every 6 to 8 hours, but do not use it more than four times in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds (under 2 years), it's best to consult a doctor for guidance.

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, 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. Symptoms to watch for include chest pain, trouble breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If your child experiences any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, or if their symptoms worsen or do not improve within a few days, you should consult a doctor immediately. Always seek medical advice if your child has any pre-existing health conditions or is taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, 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 using ibuprofen and contact your doctor right away.

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

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby. These risks can include potential heart problems and kidney issues for the fetus.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the safest options for managing any discomfort you may experience.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own discomfort.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 10 years, the dosage depends on their weight and age, so it's best to follow the dosing chart provided or consult your doctor for guidance.

Make sure to monitor your child closely. If they have a history of allergic reactions to pain relievers or fever reducers, or if they have stomach issues, consult a doctor before use. Additionally, if your child has been dehydrated from vomiting or diarrhea, or if they show any signs of stomach bleeding, stop the medication and seek medical advice. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, contact a doctor for further assistance.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke.

Please note that the product does not provide specific directions or complete warnings for adult use, which means you should seek professional guidance to ensure safety and proper usage. Taking these precautions can help manage health risks effectively.

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 doctor can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For example, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup to measure your dose accurately; avoid using any other device. It's best to determine the right dose based on weight, but if that's not possible, you can use age instead. Remember to shake the bottle well before each use and check that the printed neckband is intact before taking the medication. Store it at room temperature between 20-25°C (68-77°F) and do not freeze it.

FAQ

What is ibuprofen used for?

Ibuprofen is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What age group can use ibuprofen?

Ibuprofen is intended for children ages 2 to 11 years.

How long does the effect of ibuprofen last?

The effects of ibuprofen can last up to 8 hours.

What is the recommended dosing for a child weighing 36-47 lbs?

For a child weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

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

Consult a doctor before using ibuprofen if your child has a history of stomach problems, such as heartburn.

Can ibuprofen be used during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

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

If your child experiences signs of stomach bleeding, such as feeling faint or vomiting blood, stop use and consult a doctor immediately.

How should ibuprofen be administered?

Ibuprofen should be given orally, and you should use only the enclosed dosing cup to measure the dose.

What precautions should be taken when using ibuprofen?

Do not exceed the recommended dose, and consult a doctor if your child has high blood pressure, heart disease, or is taking other medications.

What flavor does ibuprofen come in?

Ibuprofen oral suspension comes in a grape flavor.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen oral suspension is formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a concentration of 100 mg per 5 mL. This preparation is designed for oral administration and is presented in a grape flavor. The product is alcohol-free and paraben-free, ensuring suitability for a wide range of patients. Each bottle contains 4 fluid ounces (120 mL) of the suspension.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be employed.

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is critical to adhere to the prescribed dosing limits and consult a healthcare professional if there are any questions or concerns regarding the use of this product.

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 such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases this risk.

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 amplified 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, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

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

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as 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, further medical assessment is necessary. Caregivers should also be alert for the emergence of any new symptoms.

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 warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage may increase this risk.

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, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include gastrointestinal symptoms such as stomach pain, which may indicate potential bleeding. Patients should be advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Other serious symptoms warranting immediate medical consultation include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, which may indicate heart problems or stroke.

Patients should not use this product for more than two days for sore throat symptoms without consulting a healthcare provider, especially if accompanied by high fever, headache, nausea, or vomiting.

It is recommended that patients consult a healthcare professional before use if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients under a doctor's care for serious conditions or those taking other medications should seek advice prior to use.

If symptoms do not improve within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients should contact their healthcare provider. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a consultation.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is further elevated in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, or naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be warranted based on the patient's overall medication regimen and clinical status.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

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

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

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing may also be adjusted as directed by a doctor. The medication should not be used for more than 2 days in children under 3 years of age without medical advice.

Healthcare professionals should advise caution if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers. Additionally, consultation with a doctor is recommended if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers.

If the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea, a doctor should be consulted prior to use. Signs of potential stomach bleeding, including faintness, vomiting blood, black or bloody stools, or persistent stomach pain, warrant immediate cessation of the medication and consultation with a healthcare provider.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, particularly in the presence of underlying health conditions. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or have experienced a stroke.

Due to the lack of specific directions or complete warnings for adult use, healthcare providers should carefully evaluate the potential risks and benefits of administering this product to elderly patients. Monitoring for adverse effects and adjusting dosages as necessary may be warranted to ensure patient safety.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with risks to the fetus, including potential cardiovascular effects and renal impairment. Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. 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, 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 medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate the management of therapy in the context of hepatic impairment. Regular follow-up and reassessment of liver function are advised to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

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 recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be advised to consult a healthcare professional if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Furthermore, it is essential to ask a doctor before use if the child has asthma or is taking a diuretic.

Lastly, healthcare providers should 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness.

Additional Clinical Information

Patients should be informed that the medication is administered orally and may be repeated every 6-8 hours as needed, with a maximum of four doses per day. It is recommended to take the medication with food or milk if stomach upset occurs.

Clinicians should advise patients to use only the enclosed dosing cup for administration, ensuring they refer to the dosing chart to determine the appropriate dose based on weight or age. The medication should be shaken well before use and not used if the printed neckband is broken or missing. Proper storage conditions include maintaining a temperature of 20-25°C (68-77°F) and avoiding freezing.

Drug Information (PDF)

This file contains official product information for 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 Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.