Careone Infants Acetaminophen

Description

CAREone® is a suspension liquid formulation intended for use in children aged 2 to 3 years. Each 5 mL dose contains 160 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is alcohol-free, aspirin-free, ibuprofen-free, dye-free, and gluten-free. It is presented in a 2 FL OZ (59 mL) container and is flavored with cherry. 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 does not contain complete directions or warnings for adult administration. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as indicated in the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

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

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

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

3. Pull the yellow part of the syringe until it reaches and remains at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

For dosing specifics:

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

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

It is essential to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. After use, the cap should be replaced tightly to maintain child resistance.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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

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

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount 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, or 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, 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 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 signs or symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Patients should be monitored for signs of liver injury, particularly in those with pre-existing liver disease.

Additionally, there is an allergy alert indicating that acetaminophen may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek 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 without delay.

It is advised that patients stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Before using this product, it is recommended that caregivers consult a healthcare provider if the child has liver disease. Furthermore, it is important to seek advice from a doctor or pharmacist if the child is currently taking the blood-thinning medication warfarin, as interactions may occur.

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

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. It is advised to use weight for dosing whenever possible; if weight is not available, age may be used as a guide.

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

For accurate dosing, it is essential to refer to the provided dosing chart and to use only the enclosed syringe specifically designed for this product. Other dosing devices should not be utilized.

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 evaluate 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

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 statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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. Careful evaluation is necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

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

Nonclinical Toxicology

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

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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Providers should also instruct patients not to exceed the recommended dose, highlighting the importance of adhering to dosage guidelines to prevent potential overdose.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, it is important for healthcare providers to remind patients to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is vital to avoid any potential interactions that could compromise the child's health.

Storage and Handling

The product is supplied in a configuration that includes a specific syringe designed exclusively for its use. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety.

Healthcare professionals should inspect the product prior to use; it must not be utilized if the printed neckband is broken or missing, as this indicates potential tampering. After each use, the cap should be replaced tightly to maintain child resistance, ensuring that the product remains secure and out of reach of children.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek medical attention if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, 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)