Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Childrens Ibuprofen

Last content change checked dailysee data sync status

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 2026
Label revision date
March 12, 2026
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 2026
Label revision date
March 12, 2026
Manufacturer
Advagen Pharma Ltd.
Registration number
ANDA220239
NDC root
72888-479
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 is a medication that contains ibuprofen, a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. Additionally, it helps to reduce fever, making it a useful option for managing discomfort in children.

This oral suspension is available in a 120 mL bottle, providing an easy way to administer the medication to children when they need relief from pain or fever.

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 using this product, make sure to shake it well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. Always use the enclosed dosing cup to measure the dose accurately—do not use any other device.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 milliliters (mL). If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For those aged 6 to 8 years and weighing 48 to 59 pounds, the dose is 10 mL. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, the dose is 12.5 mL, and for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. Always remember to stick to the recommended amounts and consult a doctor if you have any questions.

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 safety by following these guidelines closely. If you have any concerns or questions about your child's health or medication, consult with a healthcare professional for personalized advice.

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, or skin rash. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, particularly in those with a history of stomach ulcers or those taking certain other medications.

There is also an increased risk of heart attack and stroke associated with ibuprofen use, especially if taken in higher doses or for longer than recommended. If you notice symptoms like chest pain, trouble breathing, or weakness on one side of the body, seek medical attention right away. It's crucial to consult a doctor if your child experiences severe sore throat symptoms, does not improve within 24 hours, or if fever or pain worsens after three days. Always talk to a healthcare professional before using ibuprofen if your child has any underlying 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 the medication and seek medical help immediately.

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

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this important time.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of ibuprofen on nursing infants haven't 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

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children who are older, the dosage depends on their weight and age. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor before use. For children aged 2-3 years weighing between 24-35 lbs, the recommended dose is 5 mL. As the weight increases, so does the dosage, with specific amounts outlined for different age and weight categories.

Before giving this medication, it's important to check with a doctor if your child has any history of stomach issues, dehydration, high blood pressure, heart disease, liver or kidney problems, or if they are taking certain medications like diuretics (which help remove excess fluid from the body). You should also stop using the medication and consult a doctor if your child shows signs of heart problems or stroke, does not feel better within 24 hours, experiences worsening fever or pain lasting more than 3 days, or develops any new symptoms.

Geriatric Use

While the drug insert for Children's Ibuprofen does not provide specific information about its use in older adults, it primarily focuses on children. This means there are no recommended age considerations, dosage adjustments, or safety concerns specifically outlined for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before administering any medication, including Children's Ibuprofen, to ensure it is appropriate and safe for their individual health needs.

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 standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to consider this when prescribing medications or adjusting dosages in the future. Regular check-ups and open communication are key to managing your health effectively.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use; do not use the product if the carton is open or if the tape or tamper-evident ring on the cap is broken or missing. This helps to ensure that the product remains sterile and safe for use.

Always handle the product with care, following these guidelines to maintain its integrity and your safety. If you have any questions about proper storage or handling, feel free to reach out for more information.

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 should I do if my child has an allergic reaction to ibuprofen?

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

How should I dose Children's Ibuprofen Oral Suspension?

You should find the right dose on the dosing chart based on your child's weight and age. Use only the enclosed dosing cup and do not exceed the recommended dosage.

Can I give ibuprofen to my child if they are under 3 years old?

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

What are the storage instructions for this medication?

Store Children's Ibuprofen Oral Suspension between 20-25°C (68-77°F) and do not use if the carton is open or if the tamper-evident ring of the cap is broken or missing.

Is it safe to use 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.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as vomiting blood or having bloody stools, stop use and seek medical attention immediately.

Can nursing mothers use ibuprofen?

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

What are the warnings associated with ibuprofen?

Warnings include the risk of severe allergic reactions, stomach bleeding, heart attack, and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, 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

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

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of 4 doses per day. The following dosing chart provides specific guidance:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the recommended dosage and should advise caregivers to seek medical guidance if there are any uncertainties regarding dosing.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 this adverse effect 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, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

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 prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if such symptoms occur. 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.

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.

Discontinuation of ibuprofen and consultation with a healthcare professional is warranted if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical evaluation is essential.

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, or if any new symptoms develop, it is crucial to seek medical advice promptly.

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 immediately and seek 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 advised to adhere strictly to dosing instructions to minimize this risk.

Additionally, NSAIDs, excluding aspirin, have been 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 higher doses or for extended periods.

Patients should also be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition requiring prompt medical evaluation.

Patients are advised to stop using ibuprofen and consult a healthcare provider 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.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. Redness or swelling in the affected area or the emergence of new symptoms should also prompt consultation with a healthcare professional.

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

Finally, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare provider or pharmacist before using ibuprofen.

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

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

  • For patients weighing under 24 lbs (under 2 years), consultation with a doctor is required.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, has not been 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, or a history of stroke. Additionally, if the child is taking a diuretic, medical advice should be sought prior to administration.

Parents should be instructed to discontinue use and consult a doctor if the child exhibits symptoms of heart problems or stroke, does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise.

Geriatric Use

The prescribing information for Children's Ibuprofen does not provide specific details regarding its use in geriatric patients. The insert primarily emphasizes pediatric use and lacks any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric patients, given the absence of data. It is advisable to monitor elderly patients closely for any potential adverse effects or interactions, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options. It is essential for healthcare professionals to consider these factors when prescribing medications to 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 patients 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 outlined 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. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, no information is provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, there have been cases of cardiovascular events, such as heart attack and stroke, linked to the use of NSAIDs. Reports of allergic reactions, including anaphylaxis and angioedema, have been received. Instances of elevated blood pressure in patients taking ibuprofen have been noted, along with reports of dizziness and headache as side effects. Furthermore, there have been reports of gastrointestinal ulcers and perforations, some of which have resulted in fatal outcomes.

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 assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to stop using the medication 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. Additionally, 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, they should also discontinue use and seek medical advice.

It is important to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Furthermore, if fever or pain worsens or persists for more than three days, or if there is any redness or swelling in the painful area, medical advice should be sought. Patients should also be aware that any new symptoms that arise warrant a consultation with a healthcare professional.

When administering this product, patients should be advised to take it with food or milk if stomach upset occurs. 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 also be advised to seek medical advice 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 crucial 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, patients should be reminded to discuss any current medications with their healthcare provider or pharmacist, especially if the child is taking a diuretic or is under care for any serious condition.

Storage and Handling

The product is supplied in a secure carton. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Healthcare professionals should ensure that the carton remains unopened and that the carton tape and tamper-evident ring of the cap are intact. If the carton is open or if there are any signs of tampering, the product should not be used.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

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.