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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
June 5, 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
June 5, 2024
Manufacturer
American Sales Company
Registration number
M013
NDC root
41520-615
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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 effective in reducing fever and alleviating minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

This medication is alcohol-free, aspirin-free, and ibuprofen-free, making it a suitable option for children with specific dietary restrictions, as it is also gluten-free. The pleasant cherry flavor and included dosage cup make it easier for you to administer the correct amount to your child.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by various conditions, including the common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief. It's important to follow the recommended guidelines for use to ensure you get the best results.

Dosage and Administration

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

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

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 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

You should be aware that 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, there is a risk of serious skin reactions, such as reddening, blisters, or rash. If any of these symptoms occur, 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 also important to avoid using this product if your child has had an allergic reaction to it or any of its ingredients. Always check with a doctor 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 contact a healthcare professional. In case of overdose, seek medical assistance immediately.

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 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.

Before using this product, it's wise to check with 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 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 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

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. They can help you weigh the potential benefits and risks based on your individual situation. 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 are no noted concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

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.

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 its ingredients, do not use it. Seek medical help if pain worsens or lasts more than 5 days, fever persists for more than 3 days, new symptoms appear, or if there is redness or swelling. Always keep the medication out of reach of children, and in case of overdose, contact a Poison Control Center immediately. Use the enclosed dosing cup for accurate measurement, and avoid using any other devices.

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 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 managed and that the treatment is safe for your child's specific health needs. 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 with 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. Warfarin helps prevent blood clots, and combining it with other medications can affect how well it works or increase the risk of side effects.

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

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, using only the enclosed dosing cup that is specifically designed for this product. It's important not to use any other dosing device to ensure accurate measurement. If you have any questions or concerns about how to take this medication, be sure to consult your healthcare provider for guidance.

FAQ

What is CAREone®?

CAREone® is an oral suspension liquid that contains acetaminophen, designed for children ages 2 to 11 years. It is 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 due to 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 should I do if my child has an allergic reaction to CAREone®?

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

Are there any warnings associated with CAREone®?

Yes, do not exceed the recommended dose, as severe liver damage may occur. If symptoms worsen or new symptoms appear, consult a doctor.

Can I use CAREone® if my child has liver disease?

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

Is CAREone® safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of CAREone® during pregnancy or nursing.

What flavor does CAREone® come in?

CAREone® is available in a cherry flavor.

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.

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 alcohol-free, aspirin-free, ibuprofen-free, and gluten-free. It is presented in a 4 FL OZ (118 mL) container and includes a dosage cup for accurate measurement. The formulation is flavored with cherry 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 ensure that the appropriate dosage is administered based on the child's weight or age, as outlined in the dosage chart below.

Prior to administration, the product must be shaken well. The child protective cap should be removed, and the prescribed dose should be squeezed into the enclosed dosing cup, which is specifically designed for use with this product. It is imperative that no other dosing device is utilized.

Dosing should be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

Dosage Chart:

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

  • 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.

Healthcare professionals should advise caregivers not to exceed the recommended dosage and to consult a doctor if there are any uncertainties regarding dosing.

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

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 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 presence of liver disease before recommending this product for use in children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

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.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. 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 amount of five doses in 24 hours or who use this product in conjunction with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of its ingredients.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the anticoagulant warfarin should consult a healthcare professional or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage to avoid overdose. If pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, patients should discontinue use and consult a doctor, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters 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 product without consulting a doctor. For children aged 2 to 11 years, dosing is based on weight, with specific volumes recommended for different weight ranges: 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 no more than 5 doses within a 24-hour period. Prior to use, healthcare professionals should be consulted if the child has liver disease or is taking the anticoagulant warfarin. The product should not be used if the child has a history of allergic reactions to it or any of its ingredients.

Parents and caregivers should 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 develop, or if there is any redness or swelling. The product must be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even if no symptoms are evident.

Dosing should be performed using the enclosed dosing cup specifically designed for this product; other dosing devices should not be used.

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 need for dosage adjustments based on individual patient factors. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when managing treatment in geriatric patients.

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 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 adequately assessed.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no specific considerations or precautions mentioned regarding the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative 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. It is crucial to monitor the patient closely and provide supportive care as needed while awaiting further medical guidance.

Nonclinical Toxicology

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

Postmarketing Experience

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

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

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer 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 against exceeding the recommended dosage, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in 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 product is administered orally. Clinicians should advise patients to use only the enclosed dosing cup specifically designed for this product and to refrain from using any other dosing device to ensure accurate dosing.

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

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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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.