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Topcare Infants 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 2011
Label revision date
July 2, 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 2011
Label revision date
July 2, 2024
Manufacturer
Topco Associates LLC
Registration number
M013
NDC root
36800-766
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

TopCare infants’ Pain & Fever is an oral suspension that contains acetaminophen (a common pain reliever and fever reducer) at a concentration of 160 mg per 5 mL. This medication is designed to help reduce fever and relieve minor aches and pains associated with conditions such as the common cold, flu, headache, sore throat, and toothache.

This product is dye-free and does not contain aspirin, ibuprofen, alcohol, parabens, or high fructose corn syrup, making it a gentle option for children. It is available in a pleasant grape flavor and comes in a 2 FL OZ (59 mL) bottle, with a pediatrician-preferred dosing system for accurate measurement.

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 provide you with relief when you're feeling unwell, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this product, 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. For children weighing under 24 pounds or younger than 2 years, it’s best to consult a doctor for the appropriate dosage. If your child weighs between 24 and 35 pounds and is 2 to 3 years old, the recommended dose is 5 milliliters (mL).

To prepare the dose, push the air out of the syringe and insert the tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe until it reaches the first dose line, then push the liquid back into the bottle. Next, pull the yellow part of the syringe again until it stays at the correct dose. When giving the medication, dispense it slowly into your child’s mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period. After use, make sure to replace the cap tightly to keep it child-resistant.

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 whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its ingredients.

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.

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. It's important not to use this product with any other acetaminophen-containing medications and to avoid it if your child has had an allergic reaction to it in the past. Always seek medical advice if your child has liver disease or is taking blood thinners like warfarin. If pain or fever worsens or lasts longer than the recommended time, or if new symptoms appear, stop use and consult a doctor. In case of overdose, contact a Poison Control Center immediately, as prompt medical attention is crucial.

Warnings and Precautions

It's important to be aware of some key warnings when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious of potential severe skin reactions, such as reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. 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 promptly.

Before using this product, check with a doctor if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, it's crucial to get emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate symptoms. 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.

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. Even if you don’t see any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for help. Your safety is the top priority.

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 consult your doctor before using this product. There is a possibility that acetaminophen, an active ingredient in the product, can pass into your breast milk. Because of this, you should exercise caution when considering its use, as there may be risks to your nursing infant. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

When giving this medication to your child, it's important to follow specific guidelines 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 recommended dose is 5 mL. Always use the enclosed syringe designed for this product, and never exceed 5 doses in a 24-hour period.

Before administering this medication, check with a doctor if your child has liver disease or is taking the blood thinner warfarin. Additionally, do not use this product if your child has had an allergic reaction to it or any of its ingredients. If your child's pain worsens or lasts more than 5 days, or if their fever persists for more than 3 days, stop using the medication and consult a doctor.

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 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it's important to consult 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 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. Mixing these medications can lead to serious complications, so always check first.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective 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, 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, repeating the dose every 4 hours as long as symptoms persist, but 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, 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 consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if new symptoms or signs of redness or swelling appear, as these may indicate a serious condition.

FAQ

What is TopCare infants’ Pain & Fever?

TopCare infants’ Pain & Fever is an oral suspension containing Acetaminophen, designed to reduce fever and relieve minor aches and pains in children.

What are the key uses of this medication?

This medication reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What should I know about dosing?

Use the enclosed syringe for dosing. For children aged 2-3 years weighing 24-35 lbs, the dose is 5 mL. For children under 2 years or under 24 lbs, consult a doctor.

Are there any warnings associated with this product?

Yes, do not exceed 5 doses in 24 hours, and avoid using with other drugs containing acetaminophen. Severe liver damage may occur if these guidelines are not followed.

What should I do in case of an overdose?

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

Can I use this medication if my child has allergies?

Do not use this product if your child has ever had an allergic reaction to it or any of its ingredients.

Is this product safe during pregnancy or breastfeeding?

The insert does not provide specific information regarding use during pregnancy. Nursing mothers should consult a doctor before use due to potential excretion in breast milk.

What are the storage instructions for this medication?

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

Packaging Info

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

Packaging configurations for Topcare Infants Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Topcare Infants 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 Infants’ Pain & Fever is an oral suspension formulated to provide relief from pain and reduce fever in children. Each 5 mL dose contains 160 mg of acetaminophen as the active ingredient. This product is dye-free and does not contain aspirin, ibuprofen, alcohol, parabens, or high fructose corn syrup. The formulation is presented in a grape flavor and is packaged in a 2 FL OZ (59 mL) bottle. It is designed for pediatric use and features a pediatrician preferred dosing system. Administration should be conducted using the enclosed syringe.

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 use in pediatric patients, and healthcare professionals should refer to the dosing chart for appropriate administration. The recommended dosing is as follows:

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician for the appropriate dose. For patients weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

Prior to administration, the product must be shaken well. The enclosed syringe, specifically designed for use with this product, should be utilized for accurate dosing. To prepare the dose, healthcare professionals should push the air out of the syringe and insert the syringe tip into the bottle opening. The bottle should then be flipped upside down, allowing the yellow part of the syringe to be pulled to the first dose line. Any excess product should be pushed back into the bottle. The yellow part of the syringe should be pulled until it reaches and remains at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. After use, the cap must be replaced tightly to ensure child resistance.

It is imperative to adhere to the dosing recommendations and not exceed the directed amount, as an overdose may occur.

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 allergic responses.

  • 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 contain acetaminophen.

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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare providers should inquire about the presence of liver disease before recommending this product. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent.

Patients should discontinue use and contact a healthcare provider 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, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum recommended dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can 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.

Additionally, if a patient 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 healthcare provider is advised.

Patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, without first consulting a healthcare professional. This product is contraindicated in individuals with a known allergy to acetaminophen or any of its components.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever worsens 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.

In cases of overdose, immediate medical attention is necessary. Patients or caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are immediately apparent, as prompt intervention is critical.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Topcare Infants Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 to 35 pounds. It is crucial to use only the enclosed syringe specifically designed for this product and not any other dosing device.

The maximum daily dosage should not exceed 5 doses within a 24-hour period. Prior to administration, healthcare professionals should advise parents to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

In cases where the child has a history of allergic reactions to this product or any of its ingredients, use is contraindicated. If pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, parents should be instructed to discontinue use and seek medical advice.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of comprehensive data, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring are recommended 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 intervention is essential, as quick medical attention can significantly impact the outcome, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Providers should also instruct patients not to exceed the recommended dose, highlighting the importance of adhering to dosage guidelines to prevent potential overdose.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, it is important for healthcare providers to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is vital to avoid any potential interactions that could compromise the child's health.

Storage and Handling

The product is supplied in a configuration that includes a printed neckband. It is essential to ensure that the neckband is intact; do not use the product if the printed neckband is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance in the event of an overdose, even if no symptoms are apparent. It is advised to consult a healthcare professional before use if the patient has liver disease or is taking warfarin. Patients should discontinue use and consult a doctor if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if new symptoms, redness, or swelling occur, as these may indicate a serious condition.

Drug Information (PDF)

This file contains official product information for Topcare Infants 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 Infants 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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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.