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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
September 1, 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 2023
Label revision date
September 1, 2025
Manufacturer
Randob Labs. , Ltd.
Registration number
ANDA209179
NDC root
52412-911
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 designed specifically for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is flavored with berry to make it more appealing for kids. This medication is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This product is alcohol-free and is formulated with a focus on the needs of children, ensuring a safe and effective option for managing pain and fever in young ones.

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 the bottle well. It's important to find the right dose based on the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age. Always use the enclosed dosing cup to measure the medication accurately—do not use any other device.

For children weighing under 24 pounds or younger than 2 years, it's best to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL. If your child weighs 36-47 pounds (ages 4-5), the dose increases to 7.5 mL. For those weighing 48-59 pounds (ages 6-8), the dose is 10 mL, and for children weighing 60-71 pounds (ages 9-10), the dose is 12.5 mL. Finally, if your child weighs between 72-95 pounds and is 11 years old, 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. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to maintain child resistance. Always follow the directions carefully and do not give more than directed.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergy may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (like aspirin or naproxen).

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, signs of stomach bleeding (such as faintness, vomiting blood, or black stools), or symptoms of heart problems or stroke (like chest pain or weakness on one side of the body), you should seek medical attention immediately. If your child does not find relief within 24 hours, or if symptoms worsen or new symptoms arise, consult a doctor.

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 issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and contact your doctor right away.

If your sore throat is severe or lasts more than two days, or if you have a high fever, headache, nausea, or vomiting, consult your doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always consult your doctor if symptoms worsen or new symptoms appear, or if you do not find relief within 24 hours.

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, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children 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

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications (conditions that would make the use of a drug inadvisable) or dosage modifications for pregnant individuals. However, since the insert does not mention any special precautions, it is always best to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy. They can provide personalized advice based on your specific situation.

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 health and your baby's well-being are the top priorities, so staying informed and vigilant is key.

Pediatric Use

When considering this medication for your child aged 2 to 11 years, it's important to follow the recommended dosage based on their weight and age. For example, children weighing between 24-35 pounds (ages 2-3) should receive 5 mL, while those weighing 72-95 pounds (age 11) can take 15 mL. However, if your child is under 24 pounds or under 2 years old, you should consult a doctor before administering this medication.

Please remember not to use this medication for more than 2 days, and avoid giving it to children under 3 years old unless directed by a healthcare professional. It's also wise to consult a doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or is currently under medical care for a serious condition or taking other medications.

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 safe and appropriate 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 consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for 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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the seal under the cap is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and safety.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL and is available in a berry flavor.

What is Children's Ibuprofen used for?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

What age group can use Children's Ibuprofen?

Children's Ibuprofen is intended for children aged 2 to 11 years.

How long does the effect of Children's Ibuprofen last?

The effects of Children's Ibuprofen can last up to 8 hours.

How should I dose Children's Ibuprofen?

You should find the right dose on the dosing chart based on your child's weight or age, and use only the enclosed dosing cup.

What should I do if my child has a severe allergic reaction?

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

What are the signs of stomach bleeding?

Signs include feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve. If these occur, stop use and consult a doctor.

Can I give Children's Ibuprofen to my child if they have had an allergic reaction to ibuprofen before?

No, do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

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

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy.

What should nursing mothers know before using Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20 to 25°C (68 to 77°F) and do not use if the carton is opened or the seal is broken.

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

Ibuprofen is an oral suspension formulated as 100 mg per 5 mL. It is presented with a berry flavor.

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 effective in reducing 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 dose based on the patient's weight or age.

Prior to administration, the product must be shaken well. The enclosed dosing cup should be used exclusively for measuring the dose; no other dosing devices should be utilized.

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

  • For patients weighing under 24 lbs or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

It is imperative not to exceed the recommended dosage. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of 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, or naproxen). Additionally, exceeding the recommended dosage or duration of use 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 symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

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

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Caregivers should also be alert for the emergence of any new symptoms and consult a healthcare professional as necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which should be monitored closely.

Severe allergic reactions can occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions to minimize this risk.

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 vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. The use of ibuprofen should not exceed two days for sore throat relief, nor should it be administered to children under three years of age without a physician's guidance.

Signs of stomach bleeding warrant immediate cessation of the medication and consultation with a healthcare provider. These signs include feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain.

Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate discontinuation of ibuprofen and prompt medical evaluation.

Additional adverse reactions may include a lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, redness or swelling in the affected area, and the emergence of any new symptoms. Patients should be advised to report these occurrences to their healthcare provider.

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight and age. The recommended doses are as follows: for children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised; for those weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), the dose is 7.5 mL; for 48-59 lbs (6-8 years), the dose is 10 mL; for 60-71 lbs (9-10 years), the dose is 12.5 mL; and for those weighing 72-95 lbs (11 years), the dose is 15 mL.

It is important to note that this medication should not be used for more than 2 days, and it should not be administered to children under 3 years of age unless directed by a doctor. Prior to use, healthcare professionals should be consulted if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child is under a doctor's care for any serious condition or is taking any other medications.

Geriatric Use

The prescribing information for Children's Ibuprofen does not provide specific guidance regarding the use of this medication in geriatric patients. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients. Consequently, healthcare providers should exercise caution when considering the use of this medication in individuals aged 65 and older, as the absence of data may necessitate careful monitoring and individualized assessment of risks and benefits. It is advisable for providers to consider alternative therapies or consult existing clinical guidelines when treating geriatric patients with conditions that may warrant the use of ibuprofen.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on nursing infants 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

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 depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can include, but are not limited to, severe drowsiness, confusion, respiratory depression, and cardiovascular instability.

In the event of suspected overdosage, immediate medical attention is warranted. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient’s clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration to limit further absorption of the substance.

  4. Specific Antidotes: If applicable, administer specific antidotes as per established protocols for the substance involved in the overdose.

Healthcare professionals should consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and reassessment of the patient’s condition are critical to ensure appropriate interventions are implemented.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is crucial for ongoing patient care and legal considerations.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, cases of anaphylaxis and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been observed in postmarketing reports. Furthermore, elevated blood pressure and heart failure have been noted in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Instances of serious allergic reactions, such as angioedema and urticaria, have been reported as well.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed 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 stomach pain that does not improve.

Additionally, patients should be informed to stop use and seek medical advice 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.

It is important to counsel patients to stop use and consult a doctor 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 redness or swelling in the affected area, or if any new symptoms arise.

Patients should be advised to take the product with food or milk if stomach upset occurs. Furthermore, healthcare providers should recommend that patients consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn.

Patients should also be encouraged to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

It is essential to advise patients to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Lastly, patients should be reminded to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a carton that must remain sealed until use. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is opened or if the seal under the cap is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Users are advised to check the bottom panel of the carton for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.

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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.