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, and gluten-free, and is presented in a grape flavor. The total volume of the product is 1 fluid ounce (30 mL). This formulation is comparable to the active ingredient found in Infants’ Tylenol® Oral Suspension.

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 directions or complete warnings for adult use. Healthcare professionals should ensure that the correct dosage is administered, adhering strictly to the dosing chart provided.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart, which recommends using the child's weight for dosing whenever possible; if weight is not available, age may be used as a guide.

To prepare the dose, the following steps should be followed:

1. Push air out of the enclosed syringe.

2. Insert the syringe tip into the bottle opening.

3. 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.

4. 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 while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose. 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 use with this product should be utilized; no other dosing devices are permitted. Healthcare professionals should also be mindful of the overdose warning and ensure that the dosage does not exceed the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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 should not be administered to children who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse effects.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose 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.

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 be vigilant regarding the management of sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied 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 the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if any redness or swelling occurs, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should stop use and consult a doctor if new symptoms arise, if pain worsens or lasts longer than five days, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

It is recommended that patients consult a doctor before using this product if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 pounds should consult a doctor before use. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dosage is 5 mL.

Caution is advised due to potential risks associated with acetaminophen. Severe liver damage may occur if a child exceeds 5 doses within a 24-hour period, which is the maximum daily amount. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

Parents and caregivers should consult a doctor before administering this product if the child has liver disease or is taking the blood-thinning medication warfarin.

While using this product, it is crucial not to exceed the recommended dose. If new symptoms arise, if pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling may indicate a serious condition, warranting immediate consultation.

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

For proper administration, caregivers should refer to the dosing chart to determine the correct dose based on the child's weight or age. Only the enclosed syringe designed for this product should be used for dosing; other devices are not recommended.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for increased sensitivity to the medication and the likelihood of comorbidities that may affect safety and efficacy.

It is essential for healthcare providers to monitor elderly patients closely for any adverse effects and to consider individual patient factors when determining the appropriateness of this product for use in this population.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential 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 in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant for any potential symptoms that may arise following an overdose. The absence of immediate symptoms does not preclude the possibility of serious complications; therefore, monitoring and evaluation should be conducted as a precautionary measure.

Management of an overdose should be guided by clinical judgment and may involve supportive care, symptomatic treatment, and specific interventions as indicated. It is crucial to follow established protocols and guidelines to ensure the safety and well-being of the patient.

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 several adverse reactions associated with the use of acetaminophen. Reports have included instances of skin reddening, blisters, and rash. Additionally, there is an allergy alert indicating that acetaminophen may cause severe skin reactions. Symptoms of such reactions may encompass skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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. Patients should be advised to discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, 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. Additionally, 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 before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes 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 packaging prior to use; the product should not be utilized if the printed bottle wrap is broken or missing, as this may compromise the safety and quality of the product. Proper handling and storage conditions are crucial to ensure optimal performance and patient safety.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if any redness or swelling occurs.

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.

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