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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 2025
Label revision date
February 4, 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 2025
Label revision date
February 4, 2025
Manufacturer
Harris Teeter, LLC
Registration number
ANDA210149
NDC root
69256-634
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Children's Ibuprofen is an oral suspension medication that belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is specifically designed for children aged 2 to 11 years and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever, providing comfort during illness.

This medication contains 100 mg of ibuprofen per 5 mL and can provide relief for up to 8 hours. It is alcohol-free and comes in a pleasant mixed berry flavor, making it easier for children to take.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; do not use any other measuring devices to ensure you get the correct amount. To find the right dose for you or your child, refer to the dosing chart provided. If possible, base the dose on weight; if not, you can use age as a guide.

Here’s a quick reference for dosing: For children under 2 years old or weighing less than 24 pounds, you should ask a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 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. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL. Always follow your doctor’s instructions if they provide different guidance.

What to Avoid

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

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, wheezing, skin reddening, facial swelling, shock, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal if used improperly.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as fainting, vomiting blood, or having black stools. Other concerning symptoms include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. If your child does not find relief within 24 hours, or if fever or pain worsens or lasts more than three days, seek medical advice. Always consult a doctor before use if your child has a history of stomach problems, is dehydrated, or has any serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin redness, facial swelling, shock, 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 or your child experience signs of stomach bleeding, such as faintness, vomiting blood, or black stools, or if there are symptoms of heart problems like chest pain or trouble breathing, stop taking ibuprofen and call your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If there is no relief within 24 hours, or if symptoms worsen or new symptoms appear, contact your healthcare provider. 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 important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not provide specific guidance on its safety. There are no stated risks or contraindications associated with ibuprofen use during pregnancy, and the insert does not mention any necessary dosage adjustments for pregnant individuals. Additionally, there are no special precautions outlined for its use in this context.

As always, it's best to consult with your healthcare provider before taking any medication while pregnant to ensure it is safe for you and your baby.

Lactation Use

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

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

Pediatric Use

When giving medication to children aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight and age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the recommended dose is 5 mL. As they grow, the dose increases: 7.5 mL for 4-5 years, 10 mL for 6-8 years, 12.5 mL for 9-10 years, and 15 mL for 11 years. However, do not use this medication for more than 2 days or give it to children under 3 years without consulting a doctor.

Be aware of potential risks, such as severe allergic reactions, especially if your child is allergic to aspirin. There is also a risk of stomach bleeding, particularly if your child has a history of stomach issues or is taking certain medications. Always consult a doctor if your child has specific health concerns, such as high blood pressure or asthma, or if they have lost fluids due to vomiting or diarrhea. If your child does not feel better within 24 hours, or if symptoms worsen or new symptoms appear, stop the medication and seek medical advice.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice, especially if you or a loved one is an older adult. They can help determine if any dosage adjustments or special precautions are necessary based on individual health needs.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a healthcare professional is essential for ensuring safety and effectiveness.

Renal Impairment

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

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

Hepatic Impairment

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

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For example, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

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

Before using the product, check that the carton is unopened and that the inner seal, which should say "SEALED for YOUR PROTECTION," is intact. If the carton is opened or the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

Additional Information

You will take this medication orally. It's important to be aware of the potential for overdose; 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?

Children's Ibuprofen is an oral suspension (liquid form) that contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and reduce fever.

What are the indications for using Children's Ibuprofen?

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

What is the recommended dosage for Children's Ibuprofen?

The dosage is 100 mg per 5 mL, and you should use the enclosed dosing cup to measure the correct amount.

What age group can use Children's Ibuprofen?

Children's Ibuprofen is indicated 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.

Are there any warnings associated with Children's Ibuprofen?

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

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

If your child experiences symptoms like faintness, vomiting blood, or black stools, stop use and call your doctor immediately.

Can I use Children's Ibuprofen if my child has 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 Children's Ibuprofen safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy or lactation.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20-25°C (68-77°F) and do not use it if the carton is opened or the inner 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

Children's Ibuprofen is an oral suspension formulation classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 5 mL dose contains 100 mg of ibuprofen, providing effective pain relief and fever reduction for pediatric patients aged 2 to 11 years. The product is alcohol-free and features a mixed berry flavor to enhance palatability. It is packaged in a 4 fluid ounce (120 mL) bottle and is designed to provide relief that lasts up to 8 hours. The product is marketed under the Harris Teeter™ brand and is comparable to the active ingredient found in Children's Motrin®. The National Drug Code (NDC) for this formulation is 69256-634-03.

Uses and Indications

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

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

Dosage and Administration

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; other dosing devices are not recommended.

Healthcare professionals should refer to the dosing chart to determine the appropriate dose, prioritizing weight for dosing when possible. If weight is not available, age may be used as a secondary reference. The dosing chart is as follows:

  • For patients weighing less than 24 lb or under 2 years of age, the dose is to be determined by a healthcare professional.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, asthma (wheezing), skin reddening, facial swelling, shock, 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 is associated with the 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 stomach bleeding.

NSAIDs, excluding aspirin, are known to elevate the risk of serious cardiovascular events, including 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. Patients should be advised not to use ibuprofen for more than two days or to administer it to children under three years of age without prior consultation with a physician.

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

Patients should be advised to discontinue ibuprofen and consult a physician if any of the following occur: signs of stomach bleeding (such as feeling faint, vomiting blood, or passing bloody or black stools), persistent stomach pain, symptoms indicative of heart problems or stroke (including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), 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, or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly 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. The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for longer than directed.

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. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare professional 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 consultation. Furthermore, if a child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using ibuprofen, it is essential to consult a healthcare provider if the patient has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health 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.

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

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is particularly pronounced in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be warranted based on the clinical scenario and the patient's overall risk profile.

No specific interactions with laboratory tests have been identified in the available data.

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 be administered the medication according to the following dosing chart based on weight and age:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

It is important to note that the medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor.

Healthcare professionals should be aware of potential allergy risks, as ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Additionally, there is an increased risk of stomach bleeding in pediatric patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs.

Before administration, it is advisable to consult a doctor if the child has a history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or is on diuretics.

If the child 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, the healthcare provider should be contacted for further evaluation.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advised, as elderly patients may respond differently to treatment compared to younger populations.

Pregnancy

There is no specific information available regarding the use of ibuprofen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with ibuprofen use in this population. Additionally, no dosage modifications for pregnant individuals are specified. The insert also 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

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

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 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 information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage. It is imperative to document the incident thoroughly and report any adverse effects to the appropriate regulatory authorities as per local regulations.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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. It is recommended that the medication be taken with food or milk if the patient experiences stomach upset.

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, healthcare providers should inform patients 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.

Patients should also be counseled 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 painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if the stomach bleeding warning is applicable to the child, if there is a history of stomach issues such as heartburn, or if the child has experienced serious side effects from pain relievers or fever reducers. It is also important to advise patients to seek medical advice if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Furthermore, patients should be encouraged to consult a doctor before use if the child has asthma, is taking a diuretic, or is under medical care for any serious condition. Lastly, it is prudent for patients to discuss with a doctor or pharmacist any other medications the child may be taking prior to use.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to verify that the printed inner seal, marked "SEALED for YOUR PROTECTION," is intact before utilizing the product.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients that in the event of an overdose, immediate medical assistance should be sought, or they should contact a Poison Control Center at 1-800-222-1222 for guidance.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.