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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
June 13, 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
June 13, 2024
Manufacturer
Topco Associates LLC
Registration number
M013
NDC root
36800-946
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 commonly used to relieve minor aches and pains, as well as to reduce fever. It is available in a grape-flavored oral suspension specifically formulated for infants, containing 160 mg of acetaminophen per 5 mL. This product is designed to help alleviate discomfort associated with conditions such as the common cold, flu, headaches, sore throats, and toothaches.

This medication is free from aspirin, ibuprofen, alcohol, and parabens, making it a preferred choice for many parents. Acetaminophen works effectively as both a pain reliever and a fever reducer, providing a gentle option for managing your child's symptoms.

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 you use this medication, it's important to know that it doesn't come with complete instructions for adult use. Always follow the recommended dosage and never give more than directed, as taking too much can be harmful. Start by shaking the bottle well. To measure the correct dose, refer to the dosing chart provided, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

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. Always use the enclosed syringe designed for this product and make sure to replace the cap tightly to keep it child-resistant. If you have any questions or concerns, consult your doctor.

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 redness, blisters, or rashes. 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 right away. It's important to avoid using this product with any other acetaminophen-containing medications and to seek medical advice if your child has liver disease or is taking blood thinners like warfarin. Always monitor for worsening pain or fever, new symptoms, or any redness or swelling, and contact a doctor if these occur. In case of overdose, seek medical assistance immediately.

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 you notice any of these symptoms, 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 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 an overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222 immediately, even if no symptoms are present.

Overdose

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 see 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 notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available regarding 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, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 administering any dose. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. Remember, you should not give more than 5 doses in a 24-hour period, as this is the maximum daily amount.

Before using this medication, check with your doctor if your child has liver disease or is taking the blood thinner warfarin. If your child has had an allergic reaction to this product or any of its ingredients, do not use it. If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop using the medication and consult a doctor. Always keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if there are no noticeable symptoms.

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 to ensure safe and appropriate use.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the right dosage and monitor for any potential side effects. Your safety and well-being are the top priority, so don't hesitate to ask questions or seek clarification about how this medication may affect you.

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 a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider can 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. 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 has 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 safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance. Before using the product, check the printed bottle wrap; do not use it if the wrap is broken or missing, as this could compromise safety.

Always handle the product with care, and follow any additional instructions provided to ensure proper use. If you have any questions about storage or handling, feel free to reach out for more information.

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. If your child has liver disease, or is taking the blood thinner warfarin, consult a doctor or pharmacist before use.

If your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, or if new symptoms, redness, or swelling appear, stop using the medication and seek medical advice.

FAQ

What is Acetaminophen used for?

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

What is the active ingredient in Acetaminophen?

The active ingredient in Acetaminophen is acetaminophen, which is present at a concentration of 160 mg per 5 mL in the oral suspension.

How should I administer Acetaminophen to my child?

Use the enclosed syringe to measure the correct dose. Shake well before using and dispense the liquid slowly into your child's mouth, toward the inner cheek.

What is the maximum dose of Acetaminophen I can give my child?

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

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 with other drugs containing acetaminophen. Additionally, watch for severe skin reactions and consult a doctor if symptoms worsen.

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, including safety concerns or dosage modifications.

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.

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

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

How should I store Acetaminophen?

Store Acetaminophen at 20-25°C (68-77°F) and do not use if the printed bottle wrap 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 infants’ Pain & Fever is an oral suspension formulation containing acetaminophen as the active ingredient, delivering 160 mg per 5 mL. This product is indicated for the relief of pain and reduction of fever. It is presented in a grape flavor and is packaged in a volume of 1 FL OZ (30 mL). The formulation is free from aspirin, ibuprofen, alcohol, and parabens. It utilizes a Pediatrician Preferred Dosing System and is intended for use with the enclosed syringe only.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, 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.

To prepare the dose, healthcare professionals should follow these steps:

  1. Push air out of the syringe before inserting the syringe tip into the bottle opening.

  2. Invert the bottle and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

  3. Pull the yellow part of the syringe 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.

For dosing specifics:

  • For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

  • For children weighing between 24 and 35 pounds or aged 2 to 3 years, the recommended dose is 5 mL.

It is imperative to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. After administration, the cap must be replaced tightly to ensure child resistance. Healthcare professionals should also be aware that the product does not contain directions or complete warnings for adult use, and caution should be exercised to avoid exceeding the directed dosage.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication 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.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious health risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Healthcare professionals should advise patients to stop use and seek medical advice if any of the following occur: worsening pain that lasts longer than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent. Prompt intervention is essential to mitigate potential health risks.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions may include significant liver damage, particularly in cases where the maximum daily dosage of acetaminophen is exceeded (more than 5 doses in 24 hours) or when used concurrently with other medications containing acetaminophen. Patients should be vigilant for signs of severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance immediately.

In clinical practice, it is advised that patients consult a healthcare provider before using this product if they have a history of liver disease or if they are taking anticoagulants such as warfarin. Additionally, patients should refrain from using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of overdose.

Patients are also cautioned to monitor their symptoms closely. If pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, medical advice should be sought. The emergence of new symptoms or the presence of redness or swelling may indicate a serious condition, warranting immediate consultation with a healthcare professional.

In the event of an overdose, it is critical to obtain medical help or contact a Poison Control Center without delay, even if no symptoms are apparent, as prompt medical attention is essential.

This product should be kept out of reach of children to prevent accidental ingestion and potential overdose.

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 other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may be heightened, leading to serious hepatic complications. 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 not be given this medication without consulting a doctor. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 to 35 pounds. It is important to adhere to the maximum daily limit of 5 doses within a 24-hour period.

Healthcare professionals should advise parents to seek medical guidance if the child has liver disease or is taking the anticoagulant warfarin. Additionally, this product should not be administered to children with a known allergy to any of its ingredients.

Parents should be instructed to discontinue use and consult a doctor if the child's pain worsens or persists beyond 5 days, or if fever increases or lasts more than 3 days. It is crucial to keep this medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for inadequate information on safety and efficacy in this population. It is essential to monitor elderly patients closely for any adverse effects and to assess the appropriateness of the dosage based on individual patient factors.

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 this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of detailed information, 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 thoroughly evaluated.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

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 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 the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified 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 contents of a medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

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, they 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.

While using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Furthermore, it is advisable for patients to seek medical advice before use if their child has liver disease. Lastly, patients should be encouraged to consult a doctor or pharmacist 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 temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use; the product should not be utilized if the printed bottle wrap is broken or missing, as this may compromise the safety and quality of the product. Proper handling and storage conditions are crucial to ensure optimal performance.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies 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 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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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.