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Childrens Ibuprofen Oral Suspension

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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 2020
Label revision date
December 26, 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 2020
Label revision date
December 26, 2025
Manufacturer
AptaPharma Inc.
Registration number
ANDA210602
NDC root
76281-128
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen Oral Suspension Original Berry Flavor is a liquid medication designed for children aged 2 to 11 years. It contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever and provides relief that can last up to 8 hours.

This dye-free oral suspension comes in a convenient 4 FL OZ (118 mL) bottle, making it easy to administer to children. Always ensure to read the product information before use to understand its intended purpose and proper usage.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and 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. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. To find the right dose, refer to the dosing chart provided. If possible, base the dose on your child's weight; if you don't have that information, you can use their age instead. It's important to use only the enclosed dosing cup to measure the medication—other devices may not provide the correct amount.

For most children, you can repeat the dose every 6 to 8 hours if needed, but remember not to exceed four doses in a single day. If your child weighs under 24 pounds (or is under 2 years old), it's best to consult a doctor before giving any medication. For children weighing between 24 and 95 pounds, the dosing chart will guide you on how much to give based on their weight. Always follow the chart or your doctor's instructions for the safest and most effective use.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to Ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious side effects, so it's important to be aware of them. You should watch for signs of a severe allergic reaction, especially if you or your child is allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If any of these occur, stop using the medication and seek medical help immediately.

There are also risks of stomach bleeding, heart attack, and stroke associated with ibuprofen, particularly if used improperly or for extended periods. Be alert for symptoms like faintness, vomiting blood, or black stools, as these may indicate stomach bleeding. Additionally, if you notice chest pain, trouble breathing, weakness on one side of the body, or slurred speech, seek medical attention right away. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

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

Ibuprofen can also lead to serious stomach bleeding, especially if your child has a history of stomach ulcers or is taking blood thinners or other NSAIDs (nonsteroidal anti-inflammatory drugs). Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be life-threatening. If your child experiences symptoms like faintness, vomiting blood, or severe stomach pain, stop the medication and call your doctor right away. It's also important to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or do not improve within a few days.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, when in doubt, it's better to err on the side of caution and get help right away.

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, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can harm the developing fetus. Research suggests that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may increase the risk of miscarriage and can lead to issues such as fetal kidney problems.

Before considering 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 risks and suggest safer alternatives for managing pain or inflammation. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when using this medication in children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor first. For children weighing 24-35 lbs (ages 2-3), the recommended dose is 5 mL, while those weighing 36-47 lbs (ages 4-5) should take 7.5 mL. The dosage increases with weight, reaching 15 mL for an 11-year-old weighing 72-95 lbs.

Before giving this medication, consult a doctor if your child has any history of stomach issues, is dehydrated from vomiting or diarrhea, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, if your child is under treatment for a serious condition or taking other medications, it's best to check with a doctor first. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the quality of the device. Additionally, always check the printed neckband before use; do not use the product if the neckband is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension 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 is the recommended dosage for a child weighing 36-47 lbs?

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

How often can I give Children's Ibuprofen to my child?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any contraindications for using this product?

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

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and call your doctor immediately.

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

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

Can nursing mothers use Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk and its effects on a nursing infant are not well studied.

What should I do if my child does not get relief within 24 hours?

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

What are the storage instructions for Children's Ibuprofen?

Store Children's Ibuprofen between 20-25° C (68-77° F) and do not use if the printed neckband is broken or missing.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide relief from pain and fever in children. Each 5 mL dose contains 100 mg of ibuprofen. The suspension is dye-free and features an original berry flavor to enhance palatability. It is available in a 4 FL OZ (118 mL) bottle.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing fever.

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

Dosage and Administration

The medication should be shaken well before use. Healthcare professionals are advised to determine the appropriate dose using the provided dosing chart, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. It is imperative to utilize only the enclosed dosing cup for administration, as other dosing devices may lead to inaccuracies.

For patients weighing under 24 lbs (under 2 years), consultation with a physician is required prior to administration. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but it is important not to exceed a total of 4 doses in a 24-hour period. Dosing should always be conducted in accordance with a physician's guidance when applicable.

Contraindications

Use is contraindicated in children with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek emergency medical assistance.

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

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to seek immediate medical attention if the child exhibits any signs of an allergic reaction or if any of the following symptoms indicative of stomach bleeding occur: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if the child shows symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, medical consultation is warranted.

Caregivers should also be advised to discontinue ibuprofen and contact a physician 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 there is noticeable redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and appropriate laboratory tests may be necessary to ensure the safe use of this medication in pediatric patients.

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. In the event of an allergic reaction, patients should discontinue use and seek immediate medical assistance.

The use of this product carries a warning for potential severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in excess or for an extended duration.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk escalates with prolonged use or higher than recommended dosages.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, and should consult a healthcare provider promptly if these symptoms occur. The product should not be used for more than two days or administered to children under three years of age without a doctor's guidance.

Common adverse reactions may include gastrointestinal symptoms, and patients should be advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Patients should seek medical advice before using this product if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider prior to use.

It is recommended that patients contact a doctor 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.

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 Oral Suspension (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a healthcare professional. For dosing, the following guidelines apply based on weight and age:

  • For children weighing under 24 lbs (under 2 years), consult a doctor before use.

  • For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lbs (ages 4-5 years), the recommended dose is 7.5 mL.

  • For those weighing 48-59 lbs (ages 6-8 years), the recommended dose is 10 mL.

  • For children weighing 60-71 lbs (ages 9-10 years), the recommended dose is 12.5 mL.

  • For those weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL.

Healthcare professionals should be consulted if the pediatric patient has a history of stomach problems, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Additionally, it is advisable to seek medical advice before use if the child is under a doctor's care for any serious condition or is taking other medications.

Parents and caregivers should discontinue use and consult a doctor if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. This product is specifically intended for use in children.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with an increased risk of miscarriage, fetal renal impairment, and other adverse effects.

Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks to the fetus against the benefits of treatment when considering the use of ibuprofen in pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to avoid using this medication right before or after heart surgery.

Healthcare providers should instruct patients to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to discontinue use and seek medical attention if the child shows symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should also be counseled to stop use and contact a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, it is recommended that it be taken with food or milk to minimize the risk of stomach upset. Healthcare providers should encourage patients 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.

Patients should be advised to seek medical advice 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. Additionally, it is important to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Finally, healthcare providers should recommend that patients discuss the use of this medication with a doctor or pharmacist if the child is taking a diuretic or is under a doctor's care for any serious condition, as well as if the child is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25° C (68-77° F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, 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 Oral Suspension, 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.