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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 2004
Label revision date
August 22, 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 2004
Label revision date
August 22, 2025
Manufacturer
Cardinal Health 107, LLC
Registration number
ANDA074937
NDC root
55154-1577
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 designed to help relieve minor aches and pains in children, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also works to reduce fever, making it a useful option for parents looking to comfort their children during illness. This suspension comes in a concentration of 100 mg per 5 mL and is provided in convenient unit dose cups for easy administration.

Uses

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

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

Dosage and Administration

When using this medication, it's important to follow the instructions provided by your healthcare professional. This product does not include complete directions or warnings for adult use, so make sure to consult with a doctor if you have any questions. Always shake the bottle well before using it, and be careful not to exceed the recommended dosage.

To find the right dose, refer to the dosing chart based on your child's weight. If possible, use their weight for the most accurate dosing; if not, you can use their age. For children weighing under 24 pounds (under 2 years), you should ask a doctor for guidance. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4-5), the dose increases to 7.5 mL. For children weighing 48 to 59 pounds (ages 6-8), the dose is 10 mL, and for those weighing 60 to 71 pounds (ages 9-10), it's 12.5 mL. Finally, for children weighing 72 to 95 pounds (11 years), the dose is 15 mL. If necessary, you can repeat the dose every 6 to 8 hours, but do not use this medication more than four times a day.

What to Avoid

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

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor before use if your child has any history of stomach issues, dehydration, or other serious health conditions.

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, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications. The information provided does not include specific guidance on the use of this product during pregnancy. Therefore, it is essential to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications you are considering during this time.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

You should be cautious when giving this medication to children. It is not recommended for children under 3 years of age unless a doctor specifically advises it. If your child has a history of allergic reactions to ibuprofen or other pain relievers, do not use this medication. For children under 24 pounds (under 2 years), consult a doctor for the correct dosage.

For children aged 2-3 years (24-35 lbs), the recommended dose is 5 mL; for ages 4-5 years (36-47 lbs), it's 7.5 mL; for ages 6-8 years (48-59 lbs), it's 10 mL; for ages 9-10 years (60-71 lbs), it's 12.5 mL; and for 11-year-olds (72-95 lbs), it's 15 mL. Always consult a doctor if your child has any underlying health issues, such as stomach problems, dehydration, high blood pressure, heart disease, liver or kidney issues, asthma, or if they are taking certain medications like diuretics. If your child shows signs of stomach bleeding or does not improve within 24 hours, seek medical advice immediately.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware that taking ibuprofen can lead to serious stomach bleeding, especially if you are also using blood thinners (medications that prevent blood clots) or steroids. The risk of stomach bleeding increases if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen. Additionally, using NSAIDs—except for aspirin—can raise the chances of heart attack, heart failure, and stroke, particularly if you take them more than recommended or for an extended period.

Before starting ibuprofen, especially for children, you should always consult with a healthcare provider. They can help you understand any potential interactions with other medications you or your child may be taking, ensuring safe and effective use.

Storage and Handling

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

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

Additional Information

When using this product, make sure to follow your healthcare professional's instructions carefully. It's important to shake the bottle well before each use. You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. Remember, this product does not provide complete directions or warnings for adult use, so always adhere to the guidance given by your healthcare provider.

Keep this product out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is CHILDREN’S IBUPROFEN ORAL SUSPENSION used for?

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

How should I dose CHILDREN’S IBUPROFEN ORAL SUSPENSION?

Use the dosing chart based on your child's weight. For children under 24 lbs (under 2 years), ask a doctor.

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

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Are there any contraindications for using this medication?

Do not use if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or right before or after heart surgery.

What are the potential side effects of CHILDREN’S IBUPROFEN ORAL SUSPENSION?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke.

How should I store CHILDREN’S IBUPROFEN ORAL SUSPENSION?

Store it at 20-25°C (68-77°F) and do not freeze.

Can I give CHILDREN’S IBUPROFEN ORAL SUSPENSION to my child if they have asthma?

Consult a doctor before use if your child has asthma or any other serious condition.

What should I do if my child does not get relief within the first day of treatment?

If your child does not get any relief within the first 24 hours, or if fever or pain worsens or lasts more than 3 days, stop use and ask a doctor.

Is there any specific information regarding the use of this product during pregnancy or nursing?

There are no specific statements regarding the use of this product during pregnancy or nursing.

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)

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

Healthcare professionals should administer this product as directed. It is essential to note that this product does not contain specific directions or complete warnings for adult use. The maximum dosage should not exceed the recommended amount.

Prior to administration, the product must be shaken well. Dosing should be determined using the provided chart, with weight being the preferred method for dosage calculation. If weight is not available, age may be used as an alternative.

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

If necessary, doses may be repeated every 6-8 hours, but the total daily administration should not exceed four doses.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

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

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

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

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless directed otherwise by a healthcare provider.

It is crucial to 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. Any new symptoms that arise should also prompt consultation with a healthcare professional.

In cases of overdose, immediate medical attention is necessary. Caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients may experience a range of adverse reactions associated with the use of this NSAID-containing product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product carries a warning for severe stomach bleeding, which is more likely to occur in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. The risk of stomach bleeding is also heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess of the directed dosage or for longer than recommended.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. The product should not be used for more than two days in such cases or in children under three years of age unless directed by a physician.

Patients are advised to discontinue use and consult a healthcare provider if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

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, or if redness or swelling occurs in the affected area, they should seek medical advice.

Before using this product, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult a healthcare professional prior to use.

Drug Interactions

Ibuprofen has several notable drug interactions that may impact patient safety and treatment efficacy.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of gastrointestinal bleeding is further heightened when ibuprofen is taken alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. Healthcare providers should evaluate the necessity of concurrent NSAID therapy and consider alternative pain management strategies to mitigate this risk.

Cardiovascular Risks Ibuprofen, along with other NSAIDs (excluding aspirin), has been associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when these medications are used beyond the recommended duration or dosage. Patients should be counseled on the importance of adhering to prescribed dosages and durations of therapy.

Pediatric Considerations In pediatric patients, it is essential to consult a healthcare professional before administering ibuprofen if the child is taking any other medications. This precaution helps to prevent potential drug interactions and ensures safe and effective treatment.

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 be given this medication unless directed by a healthcare professional. For children with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, use is contraindicated.

Dosing recommendations vary by weight and age: for children under 24 lbs (under 2 years), a doctor should be consulted for appropriate dosing. For children aged 2-3 years (24-35 lbs), the recommended dose is 5 mL; for those aged 4-5 years (36-47 lbs), the dose is 7.5 mL; for children aged 6-8 years (48-59 lbs), the dose is 10 mL; for children aged 9-10 years (60-71 lbs), the dose is 12.5 mL; and for children aged 11 years (72-95 lbs), the dose is 15 mL.

Healthcare professionals should be consulted 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. Additional caution is advised for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, consultation with a doctor is also recommended.

Parents and caregivers should be alert for signs of stomach bleeding, including faintness, vomiting blood, or the presence of bloody or black stools, and should discontinue use and seek medical advice if these occur. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, medical consultation is advised.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. It is essential to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should be informed of the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic strategies. It is crucial to consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment decisions.

Overdosage

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

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

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

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including findings from animal pharmacology and toxicology studies. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep the 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 the medication can be taken with food or milk if stomach upset occurs. It is important to instruct patients to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, patients should be made aware to discontinue 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. Healthcare providers should emphasize that 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, medical consultation is necessary.

Patients should also be advised to stop use and consult a doctor if there is any redness or swelling in the painful area, or if any new symptoms arise. It is crucial to ask a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Patients should also be advised to seek medical advice 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.

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

Additional Clinical Information

Patients should use the product as directed by their healthcare professional. It is important to note that the product does not include complete directions or warnings for adult use. Patients should not exceed the recommended dosage, which involves shaking the product well before use and repeating the dose every 6-8 hours if necessary, without exceeding four doses in a 24-hour period.

Clinicians should advise patients to keep the product 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.

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.