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Careone Infants 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 1, 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 1, 2024
Manufacturer
American Sales Company
Registration number
M013
NDC root
41520-363
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

CAREone® is a liquid medication designed for children aged 2 to 3 years, containing acetaminophen (a common pain reliever and fever reducer) at a concentration of 160 mg per 5 mL. This alcohol-free, aspirin-free, and ibuprofen-free formula is specifically formulated to help reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

The medication comes in a cherry flavor, making it more palatable for young children. It is important to use the enclosed syringe for accurate dosing.

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 using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; otherwise, you can use their age. For children under 2 years old and weighing less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL.

When you're ready to measure the dose, push the air out of the enclosed syringe (the special measuring tool included with the product) and insert the syringe tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the liquid back into the bottle. Next, pull the yellow part of the syringe until it reaches the correct dose, ensuring it stays there. Dispense the liquid slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as needed, but do not give more than 5 doses in a 24-hour period. Always replace the cap tightly after use to keep it child-resistant, and remember to use only the enclosed syringe for dosing.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its ingredients.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. It's important 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. If pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, stop use and contact a doctor. In case of overdose, seek medical assistance immediately, even if no symptoms are present.

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 redness, blisters, or rashes. 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 thinner warfarin. In case of an overdose, seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present. You should also call your doctor if your child's pain worsens or lasts more than 5 days, if a fever persists for more than 3 days, if new symptoms develop, or if there is any redness or swelling, as these could indicate a more serious issue.

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

You can feel reassured that there are no specific warnings or precautions regarding the use of Acetaminophen during pregnancy mentioned in the information provided. The insert does not indicate any contraindications (situations where the drug should not be used) or risks to the fetus associated with its use. Additionally, there are no dosage modifications or special precautions outlined for pregnant individuals, suggesting that it may be considered safe for use during this time. However, it's always best to consult with your healthcare provider before taking any medication while pregnant.

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 the dosing chart carefully. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. Always try to use your child's weight for dosing; if that's not possible, you can use their age instead.

Before administering the medication, check with your doctor if your child has liver disease or is taking the blood thinner warfarin. Make sure to use only the enclosed syringe that comes with the product for accurate dosing, as other devices may not provide the correct amount.

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 best approach tailored to your needs. 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 your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for their specific health needs. Always prioritize open communication with healthcare providers to manage any potential risks effectively.

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 certain drugs, so your healthcare provider will help determine if this medication 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. 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.

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, repeating the dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period. It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present, as quick medical attention is crucial.

Before using this medication for your child, consult a doctor if they have liver disease or are taking the blood thinner warfarin. You should also stop using the medication and consult a 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 develop, or if there is any redness or swelling, as these may indicate a serious condition.

FAQ

What is CAREone®?

CAREone® is a pain reliever and fever reducer that contains acetaminophen, specifically designed for children aged 2 to 3 years.

What are the active ingredients in CAREone®?

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

How does CAREone® work?

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

What should I do before giving CAREone® to my child?

You should consult a doctor if your child has liver disease or is taking the blood thinning drug warfarin.

How should I administer CAREone®?

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

What is the recommended dosage for CAREone®?

For children aged 2-3 years weighing 24-35 lbs, the recommended dose is 5 mL. For children under 24 lbs or under 2 years, consult a doctor.

What precautions should I take when using CAREone®?

Do not exceed 5 doses in 24 hours, and do not use with any other drug containing acetaminophen. If a skin reaction occurs, stop use and seek medical help.

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 to use during pregnancy or while nursing?

The insert does not provide specific warnings or recommendations regarding the use of CAREone® during pregnancy or lactation.

What flavor does CAREone® come in?

CAREone® is cherry-flavored and is alcohol, aspirin, and ibuprofen free.

Packaging Info

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

Packaging configurations for Careone Infants Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CAREone® is a suspension liquid formulation containing acetaminophen as the active ingredient, providing 160 mg per 5 mL. It is designed for use in children aged 2 to 3 years as a pain reliever and fever reducer. The product is alcohol-free, aspirin-free, ibuprofen-free, and gluten-free. It is presented in a cherry flavor and is packaged in a 2 FL OZ (59 mL) bottle. Administration is facilitated through the use of the enclosed syringe.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should refer to the dosing chart for appropriate administration. It is essential to shake the product well before use. The correct dose should be determined based on the child's weight; if weight is not available, age may be used as a guide.

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

  1. Push air out of the enclosed syringe and insert the syringe tip into the bottle opening.

  2. Flip the bottle upside down 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 stays 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 in a 24-hour period.

The dosing chart is as follows:

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

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

It is crucial to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for this product should be used; no other dosing devices are acceptable. Healthcare professionals should ensure that the product is not administered in excess of the recommended dosage, as indicated in the overdose warning.

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 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 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, healthcare professionals should be consulted without delay.

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

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

Patients should be advised to discontinue use and contact a healthcare professional 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, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

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 promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with a known allergy to this product or any of its ingredients should also refrain from use. Additionally, it is advisable for patients with liver disease to consult a doctor before using this product. Those taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist prior to use.

Patients are 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.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are immediately 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to anticoagulation. 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 Infants Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Careone Infants Acetaminophen.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL, or as directed by a doctor.

Caution is advised for pediatric patients with liver disease; a healthcare provider should be consulted prior to administration. Additionally, if the child is taking the anticoagulant warfarin, it is important to seek guidance from a doctor or pharmacist before use.

When determining the appropriate dose, it is preferable to use the child's weight; if weight is not available, age may be used as a guide. It is essential to utilize only the enclosed syringe specifically designed for this product and to refrain from using any other dosing device.

Geriatric Use

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

Pregnancy

Acetaminophen is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate any contraindications for pregnant patients or outline any risks to the fetus. Additionally, there are no recommended dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when advising pregnant patients on the use of Acetaminophen.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about 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 concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on their specific clinical situation.

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 quick medical attention can significantly impact the outcome, even if the individual does not exhibit any noticeable signs or symptoms of overdose.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is crucial to monitor the patient closely and provide appropriate care based on clinical judgment and established protocols.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before use 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 must not be used if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

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

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

Drug Information (PDF)

This file contains official product information for Careone Infants 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 Infants 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.