Infants Tylenol

Description

Infants' TYLENOL® is an oral suspension formulated for children, containing acetaminophen at a concentration of 160 mg per 5 mL. This product is designed specifically for infants and serves as a pain reliever and fever reducer. It is presented in a 1 fl oz (30 mL) bottle and features a cherry flavor. The formulation is dye-free and does not contain alcohol, ibuprofen, aspirin, parabens, or high fructose corn syrup. Infants' TYLENOL® utilizes the SimpleMeasure® dosing system and is intended for use with the enclosed syringe to ensure accurate dosing. The National Drug Code (NDC) for this product is 50580-599-03.

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 to determine the appropriate dosage based on the child's weight or age.

Prior to administration, the product must be shaken well. For dosing, if possible, weight should be used; otherwise, age may be utilized. The following steps outline the administration process:

1. Prepare the syringe by pushing air out of it.

2. Insert the syringe tip into the bottle opening and flip the bottle upside down.

3. Pull the yellow part of the syringe to the correct dose as indicated in the dosing chart.

4. Administer the liquid slowly into the child's mouth, directing it toward the inner cheek.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period. It is crucial not to exceed the recommended dosage. After use, ensure the cap is replaced tightly to maintain child resistance.

For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dosage. For children weighing between 24 and 35 pounds or aged 2 to 3 years, the recommended dose is 5 mL.

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 with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

Additionally, exceeding the recommended dose 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 5 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.

Allergy Alert Healthcare providers should be aware that acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning If a child presents with a 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 physician is recommended.

General Precautions Prior to administration, it is advisable to consult a healthcare professional 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, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent, as rapid intervention is essential for both adults and children.

Monitoring and Follow-Up Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 5 days, fever that worsens or persists beyond 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 dosage of five doses within a 24-hour period or who take the product concurrently with other medications containing acetaminophen. Patients should be aware that acetaminophen can cause severe skin reactions, 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 promptly. It is advised that patients do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and should verify the contents of any other medications with a doctor or pharmacist if uncertain.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

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

In the case of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not receive this medication without consulting a healthcare professional. For children aged 2 to 3 years, the recommended dose is 5 mL or as directed by a physician for those weighing between 24-35 lbs.

It is crucial to adhere strictly to the recommended dosing guidelines to avoid overdose. Parents and caregivers should ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, as prompt attention is essential for both children and adults, regardless of the presence of symptoms.

Special precautions should be taken for pediatric patients with liver disease; consultation with a healthcare provider is recommended prior to use. Additionally, if the child is taking the anticoagulant warfarin, it is important to consult a doctor or pharmacist before administering this medication.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that this product is contraindicated in children with known allergies to acetaminophen or any of the inactive ingredients. It is essential for healthcare providers to assess the potential risks associated with the use of this product in pregnant patients, particularly those with underlying liver disease, as this may exacerbate hepatic complications.

Additionally, caution is advised when considering this product for use in patients who are concurrently taking anticoagulants such as warfarin, due to the potential for drug interactions that could affect coagulation parameters.

Healthcare professionals should also emphasize the importance of adhering to the recommended dosage, as exceeding the directed amount may lead to serious adverse effects, including overdose. For children weighing less than 24 lbs or those under 2 years of age, consultation with a healthcare provider is strongly recommended prior to administration.

Overall, the safety of this product during pregnancy has not been established, and careful consideration of the benefits and risks is warranted.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 evaluate 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 medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

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 keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients included in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever intensifies or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage, and they should be made aware of the overdose warning associated with this product. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy.

Healthcare professionals should ensure that the carton tape or bottle wrap imprinted with "TYLENOL" is intact before use. If either of these seals is broken or missing, the product should not be used, as this may indicate tampering or compromised integrity. Proper handling and storage conditions are crucial for ensuring the safety and effectiveness 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 exceeding 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 blood-thinning medication warfarin. Additionally, patients should be advised to discontinue use and seek medical advice 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.

Drug Information (PDF)

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

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