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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
76281-119
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 is an oral suspension medication that contains 100 mg of ibuprofen per 5 mL. It is designed specifically for children and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours. This alcohol-free medication has a pleasant berry flavor, making it easier for children to take.

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 the medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; avoid using any other measuring devices to ensure you get the correct amount. Depending on your needs, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day.

To determine the right dose for children, you can refer to the following guidelines based on their weight and age. For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 to 47 pounds, the dose increases to 7.5 mL. For children aged 6 to 8 years weighing 48 to 59 pounds, the dose is 10 mL. If your child is 9 to 10 years old and weighs between 60 to 71 pounds, the dose is 12.5 mL. Finally, for an 11-year-old weighing between 72 to 95 pounds, the dose is 15 mL. Always follow your doctor's instructions if they provide different 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, especially in individuals who are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you notice any of these signs, stop using the medication and seek medical help immediately.

This medication also carries risks of severe stomach bleeding, particularly if your child has a history of stomach ulcers or bleeding issues, is taking blood thinners or steroids, or uses other NSAIDs (like aspirin or naproxen). Additionally, using ibuprofen can increase the risk of heart attack and stroke, especially if taken in higher doses or for longer than recommended. Be alert for signs of stomach bleeding, such as faintness, vomiting blood, or black stools, and consult a doctor if your child experiences chest pain, trouble breathing, or weakness on one side of the body. If symptoms persist or worsen, or if new symptoms arise, seek medical advice promptly.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen may lead to severe stomach bleeding, particularly 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. The risk of heart attack and stroke is also increased with NSAIDs, so it’s important to follow dosing instructions carefully.

You should stop using ibuprofen and call your doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if they show symptoms of heart problems or stroke, like chest pain or trouble breathing. If there’s no relief within 24 hours, or if fever or pain worsens or lasts more than three days, contact your doctor. For any new symptoms or if redness or swelling occurs in the painful area, it’s best to consult a healthcare professional.

In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, contact your local poison control center or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risks associated with overdosage. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of Children's Ibuprofen Oral Suspension during pregnancy is limited. The available data does not specify any risks or contraindications associated with using ibuprofen while pregnant, nor does it suggest any dosage changes for pregnant individuals.

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

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

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

Pediatric Use

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.

Always consult a doctor if your child has a history of stomach issues, has not been drinking enough fluids, or has lost fluids due to vomiting or diarrhea. It's also important to seek medical advice if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and contact a doctor immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the printed bottle neckband is intact. If either of these is broken or missing, do not use the product, as this could compromise its safety. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that provides relief from minor aches and pains and reduces fever.

How should I use Children's Ibuprofen?

Shake well before using and use only the enclosed dosing cup. Repeat the dose every 6-8 hours as needed, but do not exceed 4 doses in a day.

What are the dosing recommendations for Children's Ibuprofen?

Dosing varies by weight and age. For example, a child weighing 24-35 lbs (2-3 years) should take 5 mL.

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has had an allergic reaction to Ibuprofen or any other pain reliever, or if they are about to undergo heart surgery.

What should I do if my child experiences signs of an allergic reaction?

If your child shows symptoms like hives, facial swelling, or difficulty breathing, stop use and seek medical help immediately.

What are the warnings associated with Children's Ibuprofen?

Warnings include the risk of stomach bleeding, heart attack, and stroke, especially if used more than directed or for longer than recommended.

Can I use Children's Ibuprofen for a sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever or other symptoms.

Is Children's Ibuprofen safe for children under 3 years?

Do not use in children under 3 years of age unless directed by a doctor.

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

If your child does not experience relief within 24 hours, or if symptoms worsen or new symptoms appear, consult a doctor.

How should I store Children's Ibuprofen?

Store the product between 20-25° C (68-77° F) and do not use if the carton is opened or the bottle 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

No description information is available for the specified drug.

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

Shake the formulation well before use. Administration should be performed using only the enclosed dosing cup; the use of any other dosing device is not recommended.

Dosing is based on the patient's weight and age, as outlined in the following chart:

  • For patients weighing under 24 lb and under 2 years of age, the dose should be determined by a healthcare professional.

  • For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. Dosing may also be adjusted as directed by a healthcare professional.

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 reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs, including aspirin, ibuprofen, or naproxen. Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for an extended period.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals should be consulted promptly in such cases. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Healthcare providers should advise caregivers to discontinue ibuprofen and seek medical attention 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 call to a healthcare provider.

In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

Severe allergic reactions may occur, 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, patients should discontinue use and seek immediate medical assistance.

The use of ibuprofen, as 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 disorders, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be vigilant for signs of stomach bleeding, which may manifest as faintness, vomiting blood, bloody or black stools, or persistent stomach pain. If any of these symptoms occur, patients should stop use and consult a healthcare provider.

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 be alert for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, and seek medical attention if these symptoms arise.

Patients are advised not to use ibuprofen for more than two days for sore throat without consulting a physician, especially if the sore throat is severe or accompanied by high fever, headache, nausea, or vomiting. Furthermore, if a patient does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms develop, they should seek medical advice promptly.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen 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 and under 2 years of age, consultation with a doctor is required.

  • 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 advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been adequately hydrated due to vomiting or diarrhea. Additionally, consultation is necessary if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, a doctor should also be consulted.

Parents or guardians should be instructed to stop use and seek medical advice 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

There are no specific statements regarding the use of Children's Ibuprofen Oral Suspension during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of ibuprofen during this period. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, and specific interventions may be required based on the symptoms presented.

It is advisable to contact a poison control center or consult relevant clinical guidelines for management protocols tailored to the specific substance involved in the overdose. Continuous monitoring and supportive measures are critical in managing the patient’s condition effectively.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing management and treatment decisions.

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 indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there is a recognized risk of severe stomach bleeding associated with ibuprofen, especially in children with a history of stomach ulcers or bleeding disorders, those taking blood thinners or steroids, or those concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs).

The use of NSAIDs, including ibuprofen, has been linked to an increased risk of serious cardiovascular events, such as heart attack, heart failure, and stroke, which may be fatal. Adverse reactions reported in the postmarketing experience include symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Gastrointestinal adverse events have also been reported, including nausea, vomiting, and abdominal pain. The product is contraindicated in children who have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer, as well as in the perioperative period surrounding heart surgery. In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 be instructed to 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 emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should be advised to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be informed that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should stop use and consult a doctor. Any presence of redness or swelling in the painful area, or the emergence of new symptoms, should prompt a discussion with a healthcare provider.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for 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.

Healthcare providers should encourage patients 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, patients should be advised to consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Finally, patients should be reminded to discuss with a doctor or pharmacist before use if the child is taking a diuretic or is under medical care for any serious condition, as well as if the child is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific packaging requirements. It must be stored at a temperature range of 20-25° C (68-77° F) to ensure its stability and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use. The product should not be utilized if the carton has been opened or if the printed bottle neckband is broken or missing, as this may compromise the integrity 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.