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Careone Childrens Acetaminophen

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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 2018
Label revision date
May 7, 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 2018
Label revision date
May 7, 2024
Manufacturer
American Sales Company
Registration number
M013
NDC root
41520-624
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

CAREone® is an oral suspension liquid that contains acetaminophen (a medication commonly used to reduce fever and relieve pain) at a concentration of 160 mg per 5 mL. It is designed for children aged 2 to 11 years and is free from alcohol, aspirin, ibuprofen, and gluten, making it a suitable option for many families.

This medication is primarily used to reduce fever and alleviate minor aches and pains associated with common conditions such as the cold, flu, headaches, sore throats, and toothaches. With its grape flavor, it aims to make the experience more pleasant for 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 provide you with relief when you're feeling under the weather, making it easier to manage your symptoms and feel more comfortable.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. You’ll need to measure the correct dose based on your child's weight or age, using the dosing chart provided. For children under 2 years old and weighing less than 24 pounds, it’s best to consult a doctor for the appropriate dose. If your child is between 2 to 3 years old and weighs between 24 to 35 pounds, give them 5 milliliters (mL). For children aged 4 to 5 years and weighing 36 to 47 pounds, the dose is 7.5 mL, and for those aged 6 to 8 years and weighing 48 to 59 pounds, it’s 10 mL. If your child is 9 to 10 years old and weighs between 60 to 71 pounds, the dose is 12.5 mL, and for an 11-year-old weighing 72 to 95 pounds, it’s 15 mL.

When administering the medication, remove the child protective cap and squeeze the measured dose into the dosing cup provided. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the product to ensure accuracy, and avoid giving more than the recommended amount. If you have any questions or concerns, don’t hesitate to reach out to a healthcare professional.

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

Taking this medication can lead to some serious side effects, so it's important to be aware of them. If your child takes more than 5 doses in 24 hours, or combines it with other medications containing acetaminophen, there is a risk of severe liver damage. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If any of these skin reactions occur, stop using the medication and seek medical help immediately.

You should also consult a doctor 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. It's important to stop using the medication and seek medical advice 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.

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 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

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

If you are pregnant or planning to become pregnant, it's important to be cautious with acetaminophen. The safety of this medication during pregnancy has not been fully established, and potential risks to your baby have not been completely evaluated. Therefore, you should consult your doctor before using it.

If your healthcare provider recommends acetaminophen, be aware that dosage adjustments may be necessary. Always use this medication only if it is clearly needed and after discussing it with your healthcare professional to ensure the best outcome for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When giving this medication to your child, it's important to follow the correct dosage 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 11 years, the recommended doses are as follows: 5 mL for children weighing 24-35 pounds (ages 2-3), 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 15 mL for children weighing 72-95 pounds (age 11). Always use the dosing cup provided and never exceed the recommended amount.

It's crucial to keep this medication out of reach of children and to seek immediate medical help in case of an overdose, even if no symptoms are present. Before using the medication, 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 worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop use and contact a doctor.

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 tailored for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance. They can help ensure that the medication is safe and appropriate, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare provider to address any concerns or questions you may have.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. They can provide guidance tailored to your specific situation. Additionally, if your child has liver disease, you should also seek medical advice before use. This ensures that any potential risks are managed appropriately and that the treatment is safe for your child. Always prioritize open communication with your healthcare provider regarding any existing health conditions.

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. 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.

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

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 CAREone®?

CAREone® is an oral suspension liquid that contains acetaminophen, designed for children ages 2 to 11 years, and is used as a fever reducer and pain reliever.

What are the active ingredients in CAREone®?

CAREone® contains acetaminophen at a concentration of 160mg per 5mL.

What conditions does CAREone® help relieve?

CAREone® reduces fever and relieves minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache.

How should I administer CAREone®?

Use the enclosed dosing cup to measure the dose based on your child's weight or age, and repeat every 4 hours while symptoms last, without exceeding 5 doses in 24 hours.

Are there any warnings associated with CAREone®?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other acetaminophen-containing drugs. Additionally, watch for severe skin reactions and consult a doctor if symptoms worsen.

Can I use CAREone® if my child is pregnant or breastfeeding?

Consult a doctor before using CAREone® if your child is pregnant or planning to become pregnant, and nursing mothers should also seek medical advice due to potential excretion in breast milk.

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.

Is CAREone® gluten-free?

Yes, CAREone® is gluten-free.

What flavor does CAREone® come in?

CAREone® is available in grape flavor.

What should I do if my child's symptoms do not improve?

If pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur, stop use and consult a doctor.

Packaging Info

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

Packaging configurations for Careone Childrens Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CAREone® is an oral suspension liquid formulation containing acetaminophen at a concentration of 160 mg per 5 mL. It is designed for pediatric use in children aged 2 to 11 years and serves as a fever reducer and pain reliever. The product is alcohol-free, aspirin-free, ibuprofen-free, and gluten-free, ensuring suitability for a wide range of patients. Each 4 FL OZ (118 mL) bottle includes a dosage cup for accurate administration. The formulation is presented in a grape flavor to enhance palatability.

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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

  • For children weighing under 24 lb (under 2 years), consult a doctor for the appropriate dose.

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

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

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

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

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

It is imperative not to exceed the recommended dosage, and any concerns regarding dosing should be directed to a healthcare professional. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate for this product.

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 a medication, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in patients who have a history of allergic reactions to this product or any of its components.

Exceeding the recommended dosage is also contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period, the maximum daily amount, or if it is taken concurrently with other medications containing acetaminophen.

Acetaminophen has been 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 that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the child’s medical history, particularly regarding liver disease, prior to recommending this product. Additionally, it is essential to consult with 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 without delay, even if no symptoms are apparent, as rapid intervention can be critical.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period. This risk is further heightened if the product is taken concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. 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 where a sore throat is severe, persists for more than two days, or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists beyond three days, if new symptoms arise, or if there is any redness or swelling present. These signs may indicate a serious underlying condition that requires medical evaluation.

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 Careone Childrens Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Careone Childrens Acetaminophen.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 11 years, dosing is based on weight: 5 mL for those weighing 24-35 lb (2-3 years), 7.5 mL for 36-47 lb (4-5 years), 10 mL for 48-59 lb (6-8 years), 12.5 mL for 60-71 lb (9-10 years), and 15 mL for those weighing 72-95 lb (11 years). Dosing should not exceed the recommended amounts, and parents or caregivers should be aware of the overdose warning, which advises seeking medical help or contacting a Poison Control Center immediately in case of overdose, even if no symptoms are present.

It is important to keep this product out of reach of children. Prior to administration, a healthcare professional should be consulted if the child has liver disease, is taking the blood-thinning medication warfarin, or has a history of allergic reactions to this product or its ingredients. If pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, parents should discontinue use and consult a doctor.

This product is intended for pediatric use only and does not contain directions or warnings for adult use. The enclosed dosing cup specifically designed for this product should be used; other dosing devices are not recommended.

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 unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may have an altered pharmacokinetic and pharmacodynamic profile. Dose adjustments may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus have not been fully evaluated; therefore, caution is advised when considering the use of acetaminophen during pregnancy.

Dosage adjustments may be necessary, and it is important for healthcare providers to offer recommendations tailored to the individual patient's needs. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant 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 renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status.

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 dosage adjustments 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 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 are advised to remain vigilant and proactive in managing overdose situations. Quick medical attention can significantly influence the outcome, underscoring the importance of not delaying treatment even in the absence of overt clinical manifestations.

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 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 they have 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, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. It is also advisable for patients to seek guidance from a doctor or pharmacist if their child 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 potential tampering or compromise of the product's 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.

Drug Information (PDF)

This file contains official product information for Careone Childrens Acetaminophen, 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 Careone Childrens Acetaminophen, 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.