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Topcare Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 1995
Label revision date
February 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 1995
Label revision date
February 15, 2024
Manufacturer
Topco Associates LLC
Registration number
ANDA074937
NDC root
36800-685
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

TopCare children's Ibuprofen is an oral suspension designed for children aged 2 to 11 years. It comes in a dye-free berry flavor and contains 100 mg of ibuprofen per 5 mL. This medication is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

Uses

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

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

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 follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

Use the enclosed dosing cup to measure the dose; avoid using any other device to ensure accuracy. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. After each use, wash the dosing cup thoroughly. Finally, make sure to replace the original bottle cap to keep it child-resistant and safe.

What to Avoid

It's important to ensure your child’s safety when considering medication. You should not use this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using it right before or after heart surgery, as this can pose serious risks.

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Always follow the guidance provided by your healthcare professional to prevent any issues related to dependence (a condition where the body becomes reliant on a substance). If you have any concerns or questions, don’t hesitate to reach out to your doctor for more information.

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or if they show signs of heart problems or stroke (like chest pain or weakness on one side of the body), 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, 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 issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you 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 a doctor's guidance, 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, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s 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 during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider, as they may need to adjust the dosage or suggest alternative pain relief options. It's best to avoid using ibuprofen unless specifically directed by a medical professional. Your health and the health of your baby are the top priority, so always seek guidance when it comes to medication during pregnancy.

Lactation Use

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

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

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs between 24-35 lbs (ages 2-3), the recommended dose is 5 mL, while a child weighing 72-95 lbs (age 11) should receive 15 mL. Always use the enclosed dosing cup for accuracy and avoid using any other measuring devices.

Before giving this medication, consult your doctor if your child has a history of stomach issues, such as heartburn, or has had allergic reactions to pain relievers like ibuprofen. If your child shows any signs of stomach bleeding—such as feeling faint, vomiting blood, or having black stools—or if their symptoms do not improve within 24 hours, seek medical advice immediately. You can repeat the dose every 6-8 hours, but do not exceed four doses in a day.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the safest and most effective dosage for you. Your healthcare provider can also monitor for any potential side effects or interactions that may be more relevant for older adults.

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 doctor can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

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 (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

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 to receive the best care possible.

Drug Interactions

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

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

Storage and Handling

To ensure the safety and effectiveness 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 use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability 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. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

To help prevent stomach upset, consider taking the medication with food or milk. Remember to wash the dosage cup after each use to maintain hygiene.

FAQ

What is TopCare children's Ibuprofen?

TopCare children's Ibuprofen is an oral suspension that provides relief from minor aches and pains and reduces fever. It comes in a dye-free berry flavor, with 100 mg per 5 mL.

What age group is TopCare children's Ibuprofen intended for?

This product is intended for children aged 2 to 11 years.

How should I dose TopCare 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 4 doses in a day.

What should I do if my child experiences stomach upset?

If your child experiences stomach upset, give the medication with food or milk.

What are the signs of a severe allergic reaction to ibuprofen?

Signs may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If these occur, stop use and seek medical help immediately.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor.

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

No, do not use this product 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.

What should nursing mothers know about using ibuprofen?

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

How should I store TopCare children's Ibuprofen?

Store the product 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 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 offers a dye-free berry-flavored oral suspension containing ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. Each 5 mL dose delivers 100 mg of ibuprofen. This formulation is designed for children aged 2 to 11 years and is available in an 8 FL OZ (240 mL) bottle. The product is non-staining and alcohol-free, providing effects that last up to 8 hours.

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 utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage 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, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. Only the enclosed dosing cup should be utilized for measuring the dose; other dosing devices are not recommended.

The following dosing chart should be referenced:

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

  • For patients weighing 24-35 lbs (2-3 years), the dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed to maintain hygiene. It is essential to replace the original bottle cap after use to ensure child resistance and safety.

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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

NSAIDs, with the exception of aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. 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 healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

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

Side Effects

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

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, 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. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

In pediatric patients, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days in children under three years of age unless directed by a healthcare provider.

Patients are advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using ibuprofen, it is recommended that patients 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 asthma. Additionally, patients under a doctor's care for serious conditions or those taking other medications should seek guidance prior to use.

Drug Interactions

Ibuprofen has several notable drug interactions that healthcare professionals should consider when prescribing or recommending this medication.

Anticoagulants and Steroids Ibuprofen may increase the risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of ibuprofen with other NSAIDs, including prescription and nonprescription medications such as aspirin and naproxen, is contraindicated. This combination may lead to an increased risk of adverse effects without providing additional therapeutic benefit.

Cardiovascular Risks The use of ibuprofen, particularly at higher doses or for extended periods, may elevate the risk of serious 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 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 children under 24 lbs (under 2 years), consult a doctor before use.

  • For children weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lbs (ages 4-5 years), the recommended dose is 7.5 mL.

  • For children weighing 48-59 lbs (ages 6-8 years), the recommended dose is 10 mL.

  • For children weighing 60-71 lbs (ages 9-10 years), the recommended dose is 12.5 mL.

  • For children weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL.

Parents and caregivers should consult a doctor prior to use if the child has a history of stomach problems, such as heartburn, or has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

If the child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, use should be stopped immediately and a doctor consulted. Additionally, if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, a doctor should be contacted.

It is important to use only the enclosed dosing cup for administration and not any other dosing device. Doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to assess the appropriateness of the dosage, as adjustments may be necessary based on individual patient factors. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when considering this product for 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, including cardiovascular effects. Pregnant patients should avoid using ibuprofen unless directed by a healthcare professional. Dosage modifications may be necessary for pregnant individuals, and it is advised to consult a healthcare provider before use to ensure appropriate management and minimize risks to fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, or liver cirrhosis, as these may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course 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.

Healthcare providers should consider these factors when determining the appropriate therapeutic approach for 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 help 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 nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if any of the following conditions apply to the child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to 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.

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

Patients should be informed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also seek medical advice if the child shows symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, 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, a healthcare provider should be contacted.

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 effectiveness.

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 efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and instructing patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Additionally, patients should be reminded to wash the dosage cup after each use.

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.