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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 2014
Label revision date
May 12, 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 2014
Label revision date
May 12, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA074937
NDC root
41250-419
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Ibuprofen is an oral suspension medication designed for children ages 2 to 11 years. It is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever and is classified as a nonsteroidal anti-inflammatory drug (NSAID), which means it works by blocking certain substances in the body that cause pain and inflammation.

This particular formulation comes in a bubble gum flavor, making it more appealing for children, and it is alcohol and paraben-free. Each dose contains 100 mg of ibuprofen per 5 mL, providing effective relief that can last up to 8 hours.

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.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with complete instructions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart, which is based on your child's weight or age.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to give it more than four times in a single day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant.

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 an 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. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or if they show signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact 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 your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get 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 note that the product does not provide specific information about its use during pregnancy. While there are no explicit warnings or contraindications regarding the use of ibuprofen during this time, it is always best to consult with your healthcare provider before taking any medication. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

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

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 3 years old, you should only use this medication if directed by a doctor. If your child is between 2 and 11 years old, the dosage varies based on their weight, so make sure to follow the specific guidelines: for example, a child weighing 24-35 lbs (about 2-3 years old) should receive 5 mL, while a child weighing 72-95 lbs (11 years old) should receive 15 mL.

Before administering this medication, consult a doctor if your child has any history of stomach issues, heart problems, or serious side effects from other medications. It's also important to seek medical advice if your child has not been drinking enough fluids, has asthma, or is taking a diuretic. If you notice any signs of stomach bleeding or symptoms of heart problems, stop using the medication and contact a doctor immediately. Additionally, if your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, you should also consult a doctor.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Please note that the product does not provide specific directions or warnings for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions.

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 healthcare provider can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing any concerns with your doctor.

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 talk to your healthcare provider about any medications your child is taking, as certain drugs can interact in ways that may be harmful. For example, if your child is allergic to aspirin, taking ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners or steroids, the risk of stomach bleeding increases when taking ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Moreover, if your child has conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, the risk of serious issues like heart attack or stroke may be heightened. Always ensure that your healthcare provider is aware of all medications and health conditions to help manage these risks effectively.

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 device. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of your device.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is ibuprofen used for?

Ibuprofen is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give ibuprofen to my child?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

What should I do if my child has a stomach upset?

If your child experiences a stomach upset, give ibuprofen with food or milk.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions and stomach bleeding, especially in children with certain health conditions or those taking other medications.

Can ibuprofen be used during pregnancy?

The product does not contain specific information regarding use during pregnancy, so consult a doctor before use.

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.

Is ibuprofen safe for nursing mothers?

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

What flavor does ibuprofen come in?

Ibuprofen is available in a bubble gum flavor.

How should ibuprofen be stored?

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

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 a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. This formulation is presented as an oral suspension, containing 100 mg of ibuprofen per 5 mL. The product is flavored with bubble gum and is free from alcohol and parabens. Each bottle contains 8 fluid ounces (240 mL) of the suspension.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which considers the patient's weight and age. If possible, weight should be used to ascertain the correct dosage; otherwise, age may be utilized.

The enclosed dosing cup must be used exclusively for measuring the dose. Other dosing devices are not recommended. The following dosing chart provides guidance based on weight and age:

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

  • 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.

If necessary, doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

Healthcare professionals should be aware that 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.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, and it should not be administered to children under three years of age unless directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and seek medical attention if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In cases of overdose, it is critical to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, 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 warning for potential severe stomach bleeding. The risk of this adverse reaction 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. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the 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 or for prolonged durations.

In clinical settings, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, has been noted as a serious condition requiring prompt medical consultation. It is advised that ibuprofen not be used for more than two days in such cases or in children under three years of age unless directed by a healthcare provider.

Patients are advised to discontinue use and seek medical attention if they experience 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 evaluation. Furthermore, 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, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare professional.

Before initiating treatment with ibuprofen, it is recommended that patients consult a doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also prudent to consult a healthcare provider if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration, particularly in pediatric patients.

Allergic Reactions Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. Clinicians should assess the patient's allergy history prior to prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks In pediatric patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, the use of ibuprofen may heighten the risk of cardiovascular events, including heart attack and stroke. It is recommended that healthcare providers evaluate the overall cardiovascular risk profile of the child before initiating ibuprofen therapy.

Diuretic Interaction The use of ibuprofen in conjunction with diuretics may necessitate careful monitoring of renal function and fluid status, as NSAIDs can potentially reduce the effectiveness of diuretics and lead to fluid retention. Adjustments to the diuretic dosage may be required based on the clinical response and renal function.

In summary, clinicians should exercise caution when prescribing ibuprofen, particularly in patients with known allergies, those on anticoagulants or steroids, individuals with cardiovascular risk factors, and patients taking diuretics. Regular monitoring and potential dosage adjustments may be necessary to mitigate risks associated with these interactions.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply:

  • For children under 24 lbs (under 2 years): consult a doctor.

  • For children weighing 24-35 lbs (2-3 years): administer 5 mL.

  • For children weighing 36-47 lbs (4-5 years): administer 7.5 mL.

  • For children weighing 48-59 lbs (6-8 years): administer 10 mL.

  • For children weighing 60-71 lbs (9-10 years): administer 12.5 mL.

  • For children weighing 72-95 lbs (11 years): administer 15 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

If the child is taking a diuretic or is under a doctor's care for any serious condition, a doctor should also be consulted. Parents or guardians should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, trouble breathing, weakness on one side of the body, slurred speech, leg swelling), or if there is no relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, as it does not contain specific directions or complete warnings for adult use. It is imperative for healthcare providers to assess the individual health status of geriatric patients prior to administration.

Particular attention should be given to patients aged 65 and older who may have underlying health conditions. It is advisable for these patients to consult with a healthcare professional before use, especially if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or stroke. Monitoring for potential adverse effects and interactions is recommended to ensure patient safety.

Pregnancy

The product does not contain specific information regarding use during pregnancy. Currently, there are no explicit statements about contraindications or risks associated with the use of ibuprofen during pregnancy. Healthcare professionals should consider the lack of data when advising pregnant patients and weigh the potential benefits against any unknown risks. It is advisable to exercise caution and to discuss the use of this product with women of childbearing potential who are pregnant or planning to become pregnant.

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 a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

Patients with renal impairment 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 medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Regular assessment of liver enzymes and other relevant laboratory parameters is advised to ensure patient safety and therapeutic efficacy. If any signs of liver dysfunction arise during treatment, appropriate modifications to the therapeutic regimen should be considered.

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 potential overdose situations. 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 and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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 regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

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 to administer the medication with food or milk if the child 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 attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be made aware that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should consult a doctor. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a healthcare professional.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, 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. Additionally, patients should be advised to seek medical advice if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that only intact and properly labeled items are utilized.

Additional Clinical Information

The medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. Clinicians should advise patients to take the medication with food or milk if they experience stomach upset. In the event of an overdose, patients are instructed to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

No additional 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.

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.