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Topcare Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
July 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2019
Label revision date
July 17, 2025
Manufacturer
Topco Associates LLC
Registration number
ANDA076359
NDC root
36800-811
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

Ibuprofen Chewable Tablets contain ibuprofen, a medication that helps relieve pain and reduce fever. These chewable tablets are specifically formulated for children ages 2 to 11 years and come in a pleasant orange flavor. They are effective for alleviating minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by reducing inflammation, which helps to lower fever and ease discomfort. Each tablet provides relief that can last up to 8 hours, making it a convenient option for managing your child's symptoms.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. To find the right dose, refer to the dosing chart based on weight or age. If you need to give another dose, you can do so every 6 to 8 hours, but remember not to use it more than four times in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before administering the medication. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, they should take 1 ½ tablets. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 2 tablets. Children aged 9 to 10 years who weigh between 60 and 71 pounds should take 2 ½ tablets, and for an 11-year-old weighing 72 to 95 pounds, the dose is 3 tablets. Always ensure you are giving the correct dose based on the chart provided.

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 heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns or questions about using this medication for your child.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, excluding aspirin, particularly if used in higher doses or for extended periods. If you or your child experience severe sore throat symptoms, stomach bleeding signs (such as faintness, vomiting blood, or black stools), or symptoms of heart problems (like chest pain or trouble breathing), seek medical attention immediately. It's important to monitor for any worsening symptoms or lack of relief within the first 24 hours of treatment.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, so it’s important to use this medication only as directed. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should not use ibuprofen for more than two days in children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult a doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. Additionally, seek medical advice if fever or pain worsens or lasts more than three days, or if any new symptoms arise.

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 know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, particularly in the third trimester, because it may harm the developing fetus. Potential risks include cardiovascular problems and kidney issues for the baby.

Before considering ibuprofen, you should always consult your healthcare provider. They can offer guidance on whether it's appropriate for you and suggest any necessary dosage adjustments. It's best to avoid using ibuprofen unless your doctor specifically advises it.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Since the effects on infants who are breastfed have not been thoroughly studied, it's best to approach this situation with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to be cautious when giving this medication to children. You should avoid using it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor first. For children aged 2-3 years who weigh between 24-35 pounds, the recommended dose is 1 tablet. As the weight increases, so does the dosage, with specific amounts outlined for each age and weight category.

If your child needs another dose, you can repeat it every 6 to 8 hours, but do not exceed 4 doses in a day. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, it's important to contact a healthcare professional for further guidance.

Geriatric Use

When it comes to using Topcare Children's Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, generally, elderly patients can use this medication without special considerations or safety concerns related to their age.

However, as with any medication, it's always a good idea for you or your caregiver to consult with a healthcare professional before starting any new treatment, especially if there are existing health conditions or other medications involved. This ensures that the medication is safe and appropriate for your individual health needs.

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 the dosage or monitoring are necessary based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current health conditions.

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications you may be taking. For instance, if you are using blood thinners (medications that help prevent blood clots) or steroids, taking ibuprofen could increase your risk of stomach bleeding. Additionally, using ibuprofen, especially in higher doses or for extended periods, may raise your chances of experiencing serious heart issues, such as heart attack or stroke. You should also avoid taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as this can lead to further complications.

Always discuss your current medications and any lab tests 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 best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety.

Before using the product, check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may indicate that it is no longer safe. Always handle the product with care to ensure your safety and the product's integrity.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent any burning sensation in your mouth or throat, consider taking it with food or water. If you experience stomach upset, taking it with food or milk may help.

Always 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.

FAQ

What is Ibuprofen Chewable Tablets used for?

Ibuprofen Chewable Tablets are used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lb (ages 2-3 years) should take 1 tablet, while those weighing 72-95 lb (age 11 years) should take 3 tablets.

How often can I give Ibuprofen Chewable Tablets?

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

Are there any side effects I should be aware of?

Yes, potential side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if your child experiences any severe symptoms.

Can I give this medication to my child if they have allergies?

Do not use Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester due to potential risks to the fetus.

What should I do if my child has a severe sore throat?

If your child has a severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly.

How should I administer the chewable tablets?

Chew or crush the tablets completely before swallowing. It is recommended to give them with food or water to avoid mouth or throat burning.

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 Ibuprofen Chewable Tablets?

Store the tablets between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

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

TopCare® health Ibuprofen Chewable Tablets are formulated for children aged 2 to 11 years. Each tablet contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is presented in a chewable dosage form, with a total of 24 orange-flavored tablets per package. The tablets are designed to be chewed or crushed completely before swallowing, providing relief that lasts up to 8 hours.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not include directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below. When possible, weight should be used to ascertain the appropriate dose; if weight is not available, age may be utilized instead. Doses may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is recommended.

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

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 or 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 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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the 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 extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a physician.

In the event of an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Healthcare providers should instruct caregivers to discontinue use and consult 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, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of gastrointestinal complications.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication beyond the recommended duration or dosage.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly.

Parents and caregivers are advised to discontinue use and consult a healthcare professional if a child exhibits any signs of stomach bleeding, including faintness, vomiting blood, or the presence of bloody or black stools. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

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. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Other adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. To alleviate potential stomach upset, it is recommended that ibuprofen be taken with food or milk.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

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

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen should not be administered alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. The use of multiple NSAIDs can increase the risk of adverse effects, including gastrointestinal complications.

Cardiovascular Risks The use of ibuprofen, particularly at higher doses or for extended periods, may be associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider alternative pain management strategies when appropriate.

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

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 medication unless directed by a healthcare professional. For children aged 2 to 10 years, dosing is based on weight as follows:

  • For those weighing under 24 lb and under 2 years of age, consultation with a doctor is advised.

  • Children weighing 24-35 lb (ages 2-3 years) may receive 1 tablet.

  • For those weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • Children weighing 48-59 lb (ages 6-8 years) should take 2 tablets.

  • For those weighing 60-71 lb (ages 9-10 years), the dose is 2 ½ tablets.

  • Children weighing 72-95 lb (age 11 years) may take 3 tablets.

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. Parents or caregivers should seek medical advice 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 3 days.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Topcare Children's Ibuprofen. As such, healthcare providers may not need to implement any additional precautions or modifications when prescribing this medication to geriatric patients. However, standard clinical judgment should be exercised when treating elderly patients, taking into account their overall health status and any concomitant medications they may be taking.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during this period may pose risks to the fetus, including potential cardiovascular issues and renal impairment.

Pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional. It is essential for healthcare providers to be consulted before using ibuprofen during pregnancy to ensure appropriate guidance and potential dosage modifications.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 prior to 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 to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic impairment.

Overall, a thorough assessment and ongoing monitoring are critical for optimizing treatment in patients with hepatic impairment.

Overdosage

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

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

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

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 important to inform patients that mouth or throat burning may occur, and to mitigate this, the medication should be administered with food or water. If the patient experiences stomach upset, they should take the medication with food or milk.

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 emphasize the importance of stopping use and seeking 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 informed that if the child does not experience any 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 healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if any of the following 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 hydrating; 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.

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

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product's integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with patients advised to chew or crush the tablets completely before swallowing. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients that mouth or throat burning may occur, and it is recommended to take the medication with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is advisable. Patients should be instructed 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.

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.