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Topcare 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 2002
Label revision date
December 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 2002
Label revision date
December 12, 2025
Manufacturer
Topco Associates LLC
Registration number
ANDA074937
NDC root
36800-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

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

Drug Overview

Children’s Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It comes in a bubble gum flavor and is alcohol-free, making it more appealing for kids. This medication is primarily 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.

As a nonsteroidal anti-inflammatory drug (NSAID), Children’s Ibuprofen works by blocking certain substances in the body that cause pain and inflammation, providing 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 is 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 specific directions or warnings for adults. Always make sure to shake the bottle well before each use. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age instead. Remember to use only the enclosed dosing cup for measuring, as other devices may not provide accurate amounts.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed four doses in a single day. After using the dosing cup, wash it thoroughly to keep it clean. Finally, always replace the original bottle cap to ensure it remains child-resistant and safe. If your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 and 95 pounds, the dosing chart will guide you on how much to give based on their weight or age.

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.

Be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where the body becomes reliant on a substance) can also occur, so it’s crucial to follow these guidelines closely to ensure your child's safety.

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, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (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, bloody or black stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor if symptoms persist or worsen, or if new symptoms arise.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and skin issues like rash or blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

You should also be aware that using ibuprofen can increase the risk of heart attack and stroke, particularly if taken in higher doses or for longer than recommended. If your child has a severe sore throat, especially with high fever or other concerning symptoms, consult a doctor right away. Before giving ibuprofen, check with a doctor if your child has any history of stomach issues, dehydration, or serious health conditions like high blood pressure or asthma.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using ibuprofen and call your doctor if your child experiences signs of stomach bleeding (like faintness or vomiting blood), symptoms of heart problems (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. Always be vigilant for any new symptoms or worsening of fever or pain.

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 reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any risks or contraindications associated with its use. There are also no dosage modifications recommended for pregnant individuals, and no special precautions are outlined in the insert.

However, since there is no specific guidance provided, it's always best to consult with your healthcare provider before taking any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation mentioned in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing under 24 pounds should consult a doctor, while those weighing 24-35 pounds can take 5 mL, and the dosage increases with weight up to 15 mL for those weighing 72-95 pounds.

Before giving this medication, it's important to consult a doctor if your child has a history of stomach issues, has not been drinking fluids, or has lost a lot of fluid due to vomiting or diarrhea. Additionally, if your child has high blood pressure, heart disease, liver or kidney problems, asthma, or is taking certain other medications, you should seek medical advice first. When administering the medication, consider giving it with food or milk to help prevent stomach upset. If your child shows any signs of serious side effects, such as stomach bleeding or symptoms of heart problems, or if their condition does not improve within 24 hours, contact a doctor immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your overall care effectively.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis (scarring of the liver), and a history of stroke can complicate your kidney issues.

Make sure to discuss your complete medical history with your healthcare provider, as they may need to adjust your treatment plan or monitor your kidney function more closely. This could involve regular tests to check how well your kidneys are working and ensuring that any medications you take are safe for your condition. Always follow your doctor's advice to manage your health effectively.

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 conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your care plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before using, check that the printed neckband is intact; do not use the product if the neckband is broken or missing, as this could compromise its safety.

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

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. It's important to keep this medication out of reach of children. 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 Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that provides pain relief and reduces fever for children aged 2 to 11 years. It comes in a bubble gum flavor and is alcohol-free.

What conditions does Children's Ibuprofen relieve?

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

How should I dose Children's Ibuprofen?

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

What are the dosing guidelines for Children's Ibuprofen?

For children under 2 years, ask a doctor. For ages 2-3 years, the dose is 5 mL; 4-5 years is 7.5 mL; 6-8 years is 10 mL; 9-10 years is 12.5 mL; and for 11 years, it's 15 mL.

What should I do if my child experiences stomach upset?

If your child experiences stomach upset, give Children's Ibuprofen with food or milk.

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 shows signs of stomach bleeding?

Stop use and seek medical help if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Children's Ibuprofen if my child has had an allergic reaction to pain relievers?

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

Is it safe to use Children's Ibuprofen before or after heart surgery?

No, do not use Children's Ibuprofen right before or after heart surgery.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Packaging Info

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

Packaging configurations for Topcare Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

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

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose is 7.5 mL. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, 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 should be replaced securely after each use. It is critical not to exceed the recommended dosage.

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 of such reactions can 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 increased in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of treatment.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened 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, or 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, nor should it be administered to children under three years of age unless directed by a healthcare provider.

Before administering ibuprofen, it is advisable to consult a physician if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), 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, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Parents and caregivers should discontinue use and contact a physician 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 indicative 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, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

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 longer durations than prescribed.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, 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 provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

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. Any new symptoms that arise during treatment should also be reported to a healthcare professional.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Topcare Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as follows:

  • 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

Before administering this product, healthcare professionals should advise parents to consult a doctor if the child has any of the following conditions: a history of stomach problems (e.g., heartburn), issues with pain relievers or fever reducers, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

When using this product, it is recommended to administer it with food or milk to minimize stomach upset. Parents 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, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling), does not experience relief within 24 hours, has worsening fever or pain lasting more than 3 days, shows redness or swelling in the painful area, or develops any new symptoms.

Geriatric Use

There is no specific information available 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 is no specific information available regarding the use of ibuprofen during pregnancy. The prescribing information does not mention 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 nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate 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 further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

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 hepatic decompensation occur, the treatment should be reconsidered, and appropriate medical intervention should be initiated.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to ensure effective management and to mitigate potential complications associated with the overdose.

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 several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, cases of severe allergic reactions, such as anaphylaxis, have been documented.

Cardiovascular events, including heart attack and stroke, have also been reported in association with the use of NSAIDs. Some patients experienced skin reactions, notably Stevens-Johnson syndrome and toxic epidermal necrolysis. Furthermore, elevated blood pressure has been observed in certain patients using ibuprofen. Hepatic reactions, including hepatitis and jaundice, have been noted in the postmarketing data.

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 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 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Topcare 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 Topcare 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

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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.