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Topcare Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 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 1990
Label revision date
December 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 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 1990
Label revision date
December 13, 2025
Manufacturer
Topco Associates LLC
Registration number
M013
NDC root
36800-202
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

TopCare children's Pain & Fever is an oral suspension that contains acetaminophen (a medication used to relieve pain and reduce fever) at a strength of 160 mg per 5 mL. This medication is designed for children aged 2 to 11 years and is effective in reducing fever and relieving minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache.

This product is available in a pleasant grape flavor and is formulated without aspirin, ibuprofen, alcohol, or parabens, making it a suitable option for young children.

Uses

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

This medication is designed to make you feel more comfortable when you're dealing with these everyday ailments. If you're experiencing any of these symptoms, it may be a helpful option for you.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosage chart based on their weight. If you can, use their weight for a more accurate dose; if not, you can use their age. For example, if your child weighs between 24 and 35 pounds (ages 2-3 years), you would give them 5 mL. Always use the enclosed dosing cup that comes with the product, as other devices may not provide the correct measurement.

Once you have measured the dose, remove the child protective cap and squeeze the medication into the dosing cup. You can repeat this dose every 4 hours as long as your child's symptoms persist, but remember not to exceed 5 doses in a 24-hour period. If your child weighs less than 24 pounds (under 2 years), it’s best to consult a doctor before administering this medication. Always follow the directions carefully to ensure your child's safety.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure about a medication's ingredients, it's best to consult with a doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its components.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if pain worsens or lasts more than 5 days, or if fever persists for more than 3 days, you should seek medical advice. Always check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. In case of overdose, contact a medical professional or Poison Control Center right away, even if no symptoms are present.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. In case of overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you or someone else is experiencing these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are considering using this product for your child, it's important to be aware of a few key precautions. First, do not use it if your child has ever had an allergic reaction to this product or any of its ingredients. Additionally, if your child has liver disease, you should consult a doctor before using the product. It's also essential to check with a doctor or pharmacist if your child is taking warfarin, a medication that helps prevent blood clots, as there may be interactions.

Please note that this product does not provide directions or complete warnings for adult use, so it is primarily intended for children. Always prioritize safety and consult a healthcare professional if you have any concerns or questions.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it may be wise to consult your healthcare provider for personalized advice. They can help you understand any potential risks and make informed decisions about your breastfeeding journey.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines carefully. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 pounds), 10 mL for ages 6 to 8 years (48-59 pounds), 12.5 mL for ages 9 to 10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds). Always use the dosing cup that comes with the product, as other devices may not provide the correct amount.

Before administering this medication, check with your doctor if your child has liver disease or is taking the blood thinner warfarin. Keep the medication out of reach of children, and remember that if an overdose occurs, you should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if there are no noticeable symptoms.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if it's safe and appropriate for your child. Always prioritize their health and follow professional guidance to ensure the best care.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

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). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, do not exceed 5 doses in a 24-hour period. 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, as prompt attention is crucial even if you don't see any symptoms.

FAQ

What is TopCare children's Pain & Fever?

TopCare children's Pain & Fever is an oral suspension containing Acetaminophen, 160 mg per 5 mL, designed to reduce fever and relieve minor aches and pains.

What age group is TopCare children's Pain & Fever intended for?

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

What are the main uses of TopCare children's Pain & Fever?

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

What should I do if my child has liver disease?

You should ask a doctor before using TopCare children's Pain & Fever if your child has liver disease.

How should I administer TopCare children's Pain & Fever?

Shake well before using, and use the enclosed dosing cup to measure the dose based on your child's weight or age.

What is the maximum dosage for TopCare children's Pain & Fever?

Do not give more than 5 doses in 24 hours, and repeat doses every 4 hours while symptoms last.

What should I do in case of an overdose?

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

Are there any allergies associated with TopCare children's Pain & Fever?

Yes, Acetaminophen may cause severe skin reactions. If symptoms like skin reddening, blisters, or rash occur, stop use and seek medical help immediately.

Can I use TopCare children's Pain & Fever with other medications?

Do not use it with any other drug containing acetaminophen unless advised by a doctor.

What flavor does TopCare children's Pain & Fever come in?

It comes in a grape flavor.

Packaging Info

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

Packaging configurations for Topcare Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is presented in a liquid dosage form with a concentration of 160 mg per 5 mL. The formulation includes a grape flavor as an inactive ingredient.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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 advise caregivers to adhere strictly to the dosing guidelines provided, ensuring that no more than the recommended dose is administered to avoid the risk of overdose.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

To administer the dose, caregivers should remove the child protective cap and squeeze the prescribed amount into the dosing cup provided. The dose may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb (under 2 years): Consult a doctor.

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

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

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

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

  • For children weighing 72-95 lb (11 years): Administer 15 mL.

Dosing should only be performed using the enclosed dosing cup specifically designed for this product; other dosing devices are not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

  • In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

  • Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should monitor patients for adherence to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by additional symptoms such as fever, headache, rash, nausea, or vomiting, a prompt consultation with a healthcare provider is advised to rule out serious underlying conditions.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious medical condition requiring further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are initially apparent, as timely intervention can be critical.

Prior to administration, it is essential to consult a healthcare provider if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, it is advisable to seek guidance from a healthcare professional or pharmacist before use to avoid potential drug interactions.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. Additionally, patients should discontinue use and seek medical advice if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious underlying condition.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek medical help without delay, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to anticoagulation. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Packaging configurations for Topcare Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage. For children under 2 years of age and weighing less than 24 pounds, a healthcare professional should be consulted before administration. The following dosing guidelines apply for children aged 2 years and older:

  • 2-3 years (24-35 lb): 5 mL

  • 4-5 years (36-47 lb): 7.5 mL

  • 6-8 years (48-59 lb): 10 mL

  • 9-10 years (60-71 lb): 12.5 mL

  • 11 years (72-95 lb): 15 mL

It is essential to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be used.

Healthcare professionals should advise parents to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, this product should be kept 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, as prompt medical attention is crucial even if no symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against using this product if they have a history of allergic reactions to it or any of its ingredients. It is essential for healthcare providers to assess the potential risks associated with the use of this product in pregnant patients, particularly in those with underlying conditions. Pregnant patients with liver disease should consult their healthcare provider prior to use, as liver function may influence the safety and efficacy of the product. Additionally, caution is warranted for pregnant patients who are concurrently taking anticoagulants such as warfarin; consultation with a healthcare professional is recommended to evaluate potential interactions and risks. This product does not include directions or complete warnings for adult use, and therefore, its safety profile in pregnant patients has not been fully established.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not clearly defined. It is advisable to consider the benefits of breastfeeding alongside the unknowns related to the medication's excretion in breast milk and its potential impact on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function may be required to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early recognition and management of overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate supportive care should be initiated as soon as possible.

In summary, the key steps in managing an overdose include rapid medical evaluation, contacting poison control, and vigilant monitoring for symptoms, ensuring that the patient receives the necessary care without delay.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, healthcare providers should emphasize the need to discontinue use and consult a doctor if the child's pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Furthermore, healthcare providers should recommend that patients seek medical advice before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

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

Drug Information (PDF)

This file contains official product information for Topcare Childrens Pain and Fever, 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 Pain and Fever, 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.

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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.