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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 2016
Label revision date
November 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 2016
Label revision date
November 7, 2024
Manufacturer
American Sales Company
Registration number
M013
NDC root
41520-023
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

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 available in a pleasant cherry flavor. This medication is dye-free, alcohol-free, aspirin-free, ibuprofen-free, and gluten-free, making it suitable for a variety of dietary needs.

You can use CAREone® to help reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, headaches, sore throats, and toothaches. It is comparable to the active ingredient found in Children’s Tylenol® Oral Suspension, providing a trusted option for managing your child's discomfort.

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 product, make sure to shake it well. You’ll need to measure the correct dose based on your child's weight or age, using the provided dosing chart. For example, if your child weighs between 24 and 35 pounds, the dose is 5 milliliters (mL). If they weigh between 36 and 47 pounds, the dose increases to 7.5 mL, and so on. 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.

To give the medication, remove the child protective cap and squeeze the correct amount into the dosing cup that comes with the product. You can repeat this dose every 4 hours as long as your child still has symptoms, but remember not to exceed 5 doses in a 24-hour period. Always follow the dosing instructions carefully to ensure your child's safety.

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

Always follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. If you have any questions or concerns about using this medication, don't hesitate to reach out to a healthcare professional for guidance.

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. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

You should also consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to 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. Always check with a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

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

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 notice 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 experience 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

If you are pregnant or planning to become pregnant, it's important to be cautious with acetaminophen, as its safety during pregnancy has not been fully established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not completely understood.

If your healthcare provider recommends acetaminophen, be aware that dosage adjustments might be necessary, so it's essential to follow their guidance. Always use this medication only if it is clearly needed and after discussing it with your healthcare professional.

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 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 those weighing 72-95 pounds (age 11). Remember, do not exceed 5 doses in a 24-hour period.

Always use the dosing cup that comes with the medication, as other devices may not provide the correct amount. 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, lasts more than 5 days, or if a fever persists for more than 3 days, stop use and seek medical advice. Keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222. Quick action is essential, even if there are no immediate signs of overdose.

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 for tailored advice and guidance.

Always ensure that any medication is appropriate for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that any potential risks are properly assessed and managed. Always prioritize your child's health by seeking professional guidance when it comes to their treatment options.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, using other medications that also contain acetaminophen can increase the risk of harm.

Before giving this product to your child, please consult with a doctor if they have liver disease. This ensures that you are making safe choices regarding their health and medication use.

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 your healthcare provider can help ensure safety and effectiveness.

Always keep an open line of communication with your healthcare team about any medications or treatments your child is receiving. This way, you can avoid potential interactions and make informed decisions about their health.

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 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 containing acetaminophen 160mg per 5mL, designed for children ages 2 to 11 years as a fever reducer and pain reliever.

What are the key uses of CAREone®?

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

How should I dose CAREone®?

Use the enclosed dosing cup to measure the dose based on your child's weight or age. Do not exceed 5 doses in 24 hours.

What precautions should I take when using CAREone®?

Do not use CAREone® with any other drug containing acetaminophen, and consult a doctor if your child has liver disease or is taking warfarin.

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.

Is CAREone® safe during pregnancy?

The safety of acetaminophen during pregnancy has not been established, so consult a healthcare provider before use.

Can nursing mothers use CAREone®?

Nursing mothers should consult a doctor before using CAREone®, as acetaminophen may be excreted in breast milk.

What are the potential side effects of CAREone®?

Potential side effects include severe skin reactions, liver damage from overdose, and allergic reactions. Seek medical help if any severe symptoms occur.

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 intended for children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen, serving as a fever reducer and pain reliever. The product is free from dyes, alcohol, aspirin, ibuprofen, and gluten. It is presented in a cherry flavor and is packaged in a 4 FL OZ (118 mL) bottle, which includes a dosage cup for accurate measurement.

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. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides guidance based on weight and age:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is critical not to exceed the recommended dosage, and healthcare professionals should be aware of the overdose warning associated with this product. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate.

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.

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

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, as this may further increase the risk of liver injury.

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 also be vigilant regarding sore throat symptoms. If a child presents with a 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 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 warfarin, a blood-thinning medication, to avoid potential interactions.

In cases of overdose, immediate medical attention is crucial. Caregivers should be instructed to 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 advise caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

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 dosage of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

There is also 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.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is crucial to consult a doctor promptly.

Patients should stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Furthermore, it is recommended that patients taking the blood-thinning medication warfarin consult a doctor or pharmacist before using this product to avoid potential interactions.

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 to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of 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 not be given this medication without consulting a doctor. For children aged 2 to 11 years, dosing is based on weight, with the following recommendations: 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).

It is important to limit administration to a maximum of 5 doses within a 24-hour period. If weight is not available, age may be used for dosing. The enclosed dosing cup specifically designed for this product should be utilized; other dosing devices are not recommended.

Healthcare professionals should advise parents to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. Parents should be instructed to discontinue use and seek medical advice if the child's 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.

This medication should be kept out of reach of children. 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 medical attention is crucial even if no symptoms are evident.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to assess the appropriateness of the dosage, as adjustments may be necessary based on individual patient factors. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when considering this product for geriatric patients.

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. The potential risks to the fetus are not fully understood; 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 acetaminophen 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 the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols to ensure safe and effective use of the medication.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 onset of symptoms may not be immediately apparent.

Healthcare professionals should be aware that quick medical attention is critical, even in the absence of noticeable signs or symptoms. This proactive approach can significantly influence the outcome and management of the patient’s condition.

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 includes reports of severe skin reactions associated with acetaminophen. These reactions may manifest as skin reddening, blisters, and rash. Such events have been reported voluntarily or identified through surveillance programs.

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 any uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to refrain from using this product if their child has a history of allergic reactions to it or any of its components. 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 must be cautioned not to exceed the recommended dosage, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor prior to use if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist before using this product 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, 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.

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 safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

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

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

Drug Information (PDF)

This file contains official product information for 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.