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Topcare Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
January 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
January 6, 2023
Manufacturer
Topco Associates LLC
Registration number
ANDA075217
NDC root
36800-255
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

Infants’ Ibuprofen is a concentrated oral suspension designed for children aged 6 months to 23 months. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. This medication contains 50 mg of ibuprofen per 1.25 mL and is dye-free, making it a gentle option for your little one.

As a non-steroidal anti-inflammatory drug (NSAID), Infants’ Ibuprofen works by reducing fever and relieving discomfort, providing relief that can last up to 8 hours. It comes in a pleasant dye-free berry flavor and is packaged in a 1 FL OZ (30 mL) bottle, ensuring it is easy to administer with the enclosed syringe.

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 using this product, it's important to note that it does not come with specific directions or warnings for adult use. Always make sure to follow the recommended dosage and never give more than directed.

To prepare the medication, shake the bottle well before use. You should find the right dose by referring to the dosing chart, which is based on your child's weight or age. For measuring, use the dosing device that comes with the product—do not use any other measuring tools. When giving the liquid to your child, dispense it slowly into their mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day.

For children under 6 months, it's best to consult a doctor before administering this product. For those between 12 to 23 months, the recommended doses are 1.25 mL for those weighing 12-17 lbs and 1.875 mL for those weighing 18-23 lbs. Always prioritize safety and follow these guidelines closely.

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 about your child's health or medication use.

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach pain, or any signs of heart problems or stroke, such as 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 the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they are under three years old. 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 know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular issues.

Before taking ibuprofen, you should consult your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are the top priority, so always seek professional advice.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen can potentially pass into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while breastfeeding. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 6 months and older, the dosage depends on their weight and age. For example, if your child weighs between 12-17 pounds and is 6-11 months old, the recommended dose is 1.25 mL. If they weigh between 18-23 pounds and are 12-23 months old, the dose increases to 1.875 mL.

It's important to consult a doctor before giving this medication if your child has a history of allergies to pain relievers, stomach issues like heartburn, or any serious health conditions such as high blood pressure, heart disease, or asthma. Additionally, if your child has been vomiting or has diarrhea, is not drinking fluids, or shows any signs of stomach bleeding (like feeling faint or having bloody stools), stop using the medication and seek medical advice. If your child does not feel better within 24 hours, you should also consult a doctor.

Geriatric Use

When it comes to using Topcare 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 treatment, especially if there are other health conditions or medications involved. This ensures that you receive the safest and most effective care tailored to your 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 are needed based on your kidney function. Always prioritize open communication with your doctor regarding your 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 potential interactions when taking medications like ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure safety and avoid serious side effects.

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 keep it away from freezing temperatures, as freezing can damage the product. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

Handle the product with care, following these storage guidelines to maintain its integrity. Proper storage and handling will help ensure that you can use the product safely and effectively.

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider giving it with food or milk.

Always keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Infants’ Ibuprofen used for?

Infants’ Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use Infants’ Ibuprofen?

This medication is intended for infants aged 6 months to 23 months.

How should I measure the dose of Infants’ Ibuprofen?

Use the enclosed syringe to measure the dose. Do not use any other device.

What is the recommended dose for a child weighing 12-17 lbs?

For a child weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint or vomiting blood, stop use and consult a doctor immediately.

Can I give Infants’ Ibuprofen to my child if they have had an allergic reaction to ibuprofen before?

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

Is it safe to use Infants’ Ibuprofen during pregnancy?

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

What should I do if my child does not get relief from pain or fever within 24 hours?

If your child does not experience relief within the first day of treatment, stop use and consult a doctor.

What precautions should I take when giving Infants’ Ibuprofen?

Shake well before use, give with food or milk if stomach upset occurs, and do not exceed the recommended dose.

How should I store Infants’ Ibuprofen?

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

Packaging Info

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

Packaging configurations for Topcare Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TopCare® health infants’ Ibuprofen is a concentrated oral suspension formulated for pain relief and fever reduction in infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, a non-steroidal anti-inflammatory drug (NSAID). The product is dye-free and features a berry flavor, ensuring it is suitable for sensitive populations. It is packaged in a 1 FL OZ (30 mL) bottle and is designed for use with the enclosed syringe. The formulation is non-staining and does not contain high fructose corn syrup. The effects of the medication can last 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

This product is intended for pediatric use only 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 dosing chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as a guide.

Dosing should be measured using the dosing device provided; it is imperative that no other measuring device is utilized to ensure accuracy. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing.

If necessary, the dose may be repeated every 6 to 8 hours, but it is crucial not to exceed a maximum of 4 doses in a 24-hour period.

Dosing Chart:

  • For infants under 6 months of age, consultation with a physician is required prior to administration.

  • For infants weighing 12-17 lbs (approximately 6-11 months), the recommended dose is 1.25 mL.

  • For infants weighing 18-23 lbs (approximately 12-23 months), the recommended dose is 1.875 mL.

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 carries a 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 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 the use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended guidelines.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, it is essential to consult a physician promptly. Ibuprofen should not be used for more than two days or 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 advice 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted. 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, further medical consultation is necessary. Any new symptoms that develop should also prompt a discussion with a healthcare professional.

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

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

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, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

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 necessitate 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, they should consult a healthcare professional. Redness or swelling in the painful area or the emergence of new symptoms should also prompt medical advice.

Before using this product, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical guidance prior to use. Additionally, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional or pharmacist before use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and consider alternative therapies or enhanced monitoring for patients requiring these combinations.

Additionally, it is advisable to consult a healthcare professional if the patient is concurrently using a diuretic. This consultation is important to evaluate potential interactions and to determine the need for dosage adjustments or increased monitoring of renal function and fluid status.

Packaging & NDC

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

Packaging configurations for Topcare 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 infants under 6 months, consult a doctor before use.

  • For children weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL.

  • For children weighing 18-23 lbs (12-23 months), the recommended dose is 1.875 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, or if there are concerns regarding stomach problems such as heartburn. Additionally, a consultation is warranted if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma should also be evaluated by a doctor before use. If the child is taking a diuretic or is under care for any serious condition, medical advice is essential.

Signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, necessitate immediate cessation of the medication and consultation with a doctor. If the child does not experience relief within the first 24 hours of treatment, parents or guardians should stop use and seek medical advice.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Topcare Ibuprofen. Therefore, standard dosing guidelines may be applied to this population without the need for modification. However, healthcare providers should remain vigilant in monitoring for any potential adverse effects, as individual responses to medication can vary among geriatric patients.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits.

Lactation

Nursing mothers are advised to consult a doctor prior to using ibuprofen. There is a potential for excretion of ibuprofen in breast milk, and caution is recommended when administering this medication to lactating mothers due to the potential risk to the breastfed infant.

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 liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

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

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications and may require more frequent clinical assessments to monitor for any signs of hepatic decompensation. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize patient outcomes.

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 help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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 persistent stomach pain. 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 counseled to discontinue the medication if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should 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, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Furthermore, patients should be advised to consult a doctor or pharmacist prior to 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 controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy.

Healthcare professionals should ensure that the product is not utilized 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 maintaining the quality and effectiveness of the product.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. Dosing may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Patients should be counseled to administer the medication with food or milk if stomach upset occurs. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Topcare 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 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.