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Topcare Childrens Pain and Fever

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This product has been discontinued

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 1993
Label revision date
May 22, 2024
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 1993
Label revision date
May 22, 2024
Manufacturer
Topco Associates LLC
Registration number
M013
NDC root
36800-557
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Acetaminophen is a medication designed to help relieve pain and reduce fever. It is available as an oral suspension with a cherry flavor, specifically formulated for children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen, making it effective for treating minor aches and pains associated with common conditions like the cold, flu, headaches, sore throats, and toothaches.

This medication is free from aspirin, ibuprofen, alcohol, and parabens, making it a suitable option for young children who may need relief from discomfort. By targeting pain and fever, acetaminophen can help your child feel more comfortable during illness.

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 safe in terms of teratogenic effects, meaning it does not cause birth defects. You can feel confident using it for relief from these common ailments.

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 dosing chart based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it’s best to consult a doctor for the appropriate dose. For children weighing between 24 to 35 pounds (ages 2-3 years), the dose is 5 mL; for those weighing 36 to 47 pounds (ages 4-5 years), it’s 7.5 mL; for 48 to 59 pounds (ages 6-8 years), it’s 10 mL; for 60 to 71 pounds (ages 9-10 years), it’s 12.5 mL; and for children weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

To administer the medication, remove the child protective cap and squeeze the correct dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child has symptoms, but do not give more than 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide the correct measurement. Remember, it’s important not to exceed the recommended dose.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter medication. If you're unsure whether a drug contains acetaminophen, please consult with a doctor or pharmacist for clarification.

Additionally, do not use this product if your child has ever experienced an allergic reaction to it or any of its ingredients. Taking these precautions can help ensure safety and avoid potential adverse effects.

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.

If your child experiences 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. Additionally, you should stop use and contact a 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 assistance or contact a Poison Control Center immediately, 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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling, as these could indicate a serious condition.

Overdose

Taking more than the recommended dose of medication can lead to an overdose, which is a serious situation. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t notice any signs or symptoms of an overdose.

To avoid the risk of overdose, always stick to the recommended dosage. Remember, taking more than what is advised can have harmful effects on your health. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before taking acetaminophen or any medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of acetaminophen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their weight and age. 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 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 keep this medication out of reach of children and never exceed the recommended dose, as an overdose can be serious. If you suspect an overdose, seek medical help immediately, even if there are no noticeable symptoms. Additionally, consult a doctor if your child has liver disease, is taking the blood thinner warfarin, or has had an allergic reaction to this product. If your child's pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, contact a healthcare professional. Always use the dosing cup provided with the medication for accurate measurement.

Geriatric Use

When considering this product, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should be particularly cautious and consult with a healthcare professional before using it.

Always ensure that any medication or treatment is appropriate for your individual health needs, especially if there are existing health conditions or concerns. Your healthcare provider can help guide you on safe usage and any necessary adjustments based on age-related factors.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you have any liver disease, as it may affect how your body processes the medication. Your doctor will help determine the right dosage and monitor your condition to ensure your safety while using this treatment. Always prioritize open communication with your healthcare provider about your kidney 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 this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

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. Warfarin helps prevent blood clots, and combining it with other medications can increase the risk of bleeding or other complications.

Always keep your healthcare provider informed about all medications your child is taking to ensure their safety and well-being. This way, you can avoid any potential interactions and make informed decisions about their treatment.

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, always check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

You should take this medication orally and keep it out of reach of children. If you suspect an overdose, it's important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if you don't see any symptoms.

Before using this medication for your child, consult a doctor if they have liver disease or are taking the blood thinner warfarin. Additionally, stop using the medication and reach out to a doctor if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling.

FAQ

What is Acetaminophen used for?

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

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

What should I do if my child has an allergic reaction?

If your child has ever had an allergic reaction to Acetaminophen or any of its ingredients, do not use this product and seek medical help.

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or uses it with other drugs containing acetaminophen. Additionally, it may cause severe skin reactions.

Can I use Acetaminophen if my child has liver disease?

You should ask a doctor before using Acetaminophen if your child has liver disease.

Is Acetaminophen safe to use during pregnancy?

The insert does not provide specific information regarding the use of Acetaminophen during pregnancy, so consult a doctor for guidance.

What should I do in case of an overdose?

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

How should I store Acetaminophen?

Store Acetaminophen at 20-25°C (68-77°F) and do not use it if the printed neckband is broken or missing.

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

TopCare® health Children’s Pain & Fever Oral Suspension is formulated to provide relief from pain and reduce fever in children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen as the active ingredient. The suspension is cherry-flavored and is presented in a 4 FL OZ (118 mL) bottle. This product is free from aspirin, ibuprofen, alcohol, and parabens, ensuring a gentle formulation suitable for young patients.

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 ensure that the dosage is not exceeded, adhering to the overdose warning.

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

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, the dose is to be determined by consulting a doctor.

  • For children weighing 24-35 lb or aged 2-3 years, the dose is 5 mL.

  • For children weighing 36-47 lb or aged 4-5 years, the dose is 7.5 mL.

  • For children weighing 48-59 lb or aged 6-8 years, the dose is 10 mL.

  • For children weighing 60-71 lb or aged 9-10 years, the dose is 12.5 mL.

  • For children weighing 72-95 lb or aged 11 years, the dose is 15 mL.

Dosing should be conducted only with the enclosed dosing cup; no other dosing devices should be utilized.

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 other medications, 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 allergic responses.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding sore throat symptoms. If a child presents with a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever worsens or lasts more than three days, new symptoms develop, or if redness or swelling is observed, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended to consult a doctor promptly.

Patients are advised to stop use and consult a healthcare professional if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if redness or swelling is present, as these may indicate a serious condition.

In the case of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are initially 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 combination may necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

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 aged 2 to 11 years may receive this product according to the following dosing guidelines based on weight:

  • For patients under 24 lb and under 2 years, a healthcare professional should be consulted before use.

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

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

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

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

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

It is critical not to exceed the recommended dose, and caregivers should be aware of the overdose warning: 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 essential even if no symptoms are apparent.

Caregivers should consult a healthcare professional before use if the child has liver disease or is taking the blood-thinning medication warfarin. The product should not be used if the child has a history of allergic reactions to it or any of its ingredients.

Parents and caregivers should monitor for worsening pain lasting more than 5 days, fever lasting more than 3 days, the emergence of new symptoms, or signs of redness or swelling, as these may indicate a serious condition.

This product is intended for pediatric use only and does not contain directions or complete warnings for adult use. It is important to use only the enclosed dosing cup specifically designed for this product and to keep it out of reach of children.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the individual health status and potential comorbidities of elderly patients, as these factors may influence the safety and efficacy of the treatment.

Monitoring for adverse effects and therapeutic response is recommended, given the lack of tailored guidance for this population. Healthcare providers should ensure that they assess the need for dosage adjustments based on the clinical condition and response of the elderly patient.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with acetaminophen use during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

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 and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals adhere to the recommended dosing guidelines, as exceeding the advised dosage can lead to serious health risks.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose.

It is essential to monitor the patient closely and provide supportive care as necessary while awaiting further medical guidance.

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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use immediately and seek medical assistance.

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, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients should also be encouraged to seek medical advice before using this product if their child has liver disease. Furthermore, it is advisable for patients to consult with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

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) to maintain its integrity and efficacy.

Care should be taken to ensure that the product is not used if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt attention is crucial even if no symptoms are apparent.

Patients should consult a healthcare professional before use if their child has liver disease or is taking the anticoagulant warfarin. Additionally, patients are instructed to discontinue use and consult a doctor if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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.

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.