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 is presented in a 2 fl oz (60 mL) bottle. It serves as a pain reliever and fever reducer, and is free from alcohol, ibuprofen, aspirin, and parabens. The formulation features a cherry flavor and utilizes the SimpleMeasure® dosing system, which includes an enclosed syringe for accurate administration. The product's National Drug Code (NDC) is 50580-325-01. The acetaminophen concentration is identical to that found in Children's TYLENOL.

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. It is essential to shake the product well before each use.

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

To administer the medication, healthcare professionals should follow these steps:

1. Use only the enclosed syringe specifically designed for this product; do not substitute with any other dosing device.

2. Before drawing the dose, push the air out of the syringe.

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

4. Pull the yellow part of the syringe to the correct dose.

5. Dispense the liquid slowly into the child's mouth, directing it toward the inner cheek.

The dosing interval is every 4 hours as needed while symptoms persist, with a maximum of 5 doses in a 24-hour period. After use, ensure the cap is replaced tightly to maintain child resistance. It is crucial not to exceed the recommended dosage to avoid the risk of overdose.

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 used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the 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 Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases where a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General Precautions Prior to administration, it is advisable to consult a physician 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.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as timely intervention is crucial for both adults and children, even in the absence of overt symptoms.

Stop Taking and Call Your Doctor Instructions 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, worsening fever lasting 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 within a 24-hour period or who take the product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can lead to 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. The 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 doctor or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use. It is crucial that patients adhere to the recommended dosage and avoid exceeding it, as outlined in the overdose warning.

Patients should discontinue use and consult a healthcare professional 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 is observed, as these may indicate a serious condition. In the event of an overdose, immediate medical attention is necessary, and patients should contact a Poison Control Center without delay, even if no signs or symptoms are apparent. Quick medical intervention is critical for both adults and children.

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

Healthcare providers should emphasize the importance of adhering to the prescribed dosage, as exceeding the recommended amount can lead to serious consequences. Parents and caregivers must keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is crucial for both children and adults, even if no symptoms are initially apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information primarily addresses its application in infants and children. Consequently, there are no established dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise caution when considering the use of this product in elderly patients, given the absence of data supporting its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as the lack of specific geriatric use information necessitates a careful assessment of individual patient needs and responses.

Pregnancy

The prescribing information for Infants' TYLENOL (acetaminophen) does not provide specific data regarding its use during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus associated with the use of this medication in pregnant patients. Additionally, the information does not indicate any required dosage modifications for individuals who are pregnant. Furthermore, no special precautions are outlined for the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 medication to nursing mothers, as the effects on a nursing infant are not well studied.

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 there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

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. Careful assessment and ongoing monitoring may be 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 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

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 keep this medication out of reach of children to prevent accidental ingestion. It is important 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 whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice 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.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use of this product.

Storage and Handling

The product is supplied in packaging that includes a carton and a bottle, both of which must remain intact. Specifically, the carton tape and bottle wrap should not be broken or missing, as this indicates that the product may not be safe for use.

Storage conditions require that the product be maintained at a temperature range of 20-25°C (68-77°F). It is essential to ensure that these temperature guidelines are adhered to in order to preserve the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dosing interval of every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.

View product document (PDF)