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 serves as a pain reliever and fever reducer, specifically designed for infants. It is alcohol-free, ibuprofen-free, and aspirin-free, and does not contain parabens. The formulation features a Grape flavor and is packaged in a 1 fl oz (30 mL) bottle. The product includes a SimpleMeasure® dosing syringe for accurate administration. The NDC for this product is 50580-433-01, and it is noted that the dosage strength is equivalent to that of 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.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period. After use, ensure the cap is replaced tightly to maintain child resistance.

Healthcare professionals should be aware that this product does not contain complete warnings for adult use and should not be administered in excess of the directed dosage.

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, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen. Healthcare professionals should monitor for signs of liver injury in patients using this medication.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any 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 is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised to rule out serious underlying conditions.

Healthcare professionals should inquire about any existing liver disease in pediatric patients prior to recommending this product. Additionally, it is essential to consult with a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious medical condition requiring further evaluation.

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. Additionally, the product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, unless confirmed by a healthcare provider.

Patients with a history of liver disease or those taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use. It is crucial to adhere to the recommended dosage to avoid overdose, and patients should be vigilant for signs that may necessitate discontinuation of the product. These signs include worsening pain lasting more than five days, fever persisting beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is essential. Patients are advised to contact a Poison Control Center or seek medical help without delay, even if no symptoms are apparent, as prompt 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 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 Infants Tylenol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lbs should consult a healthcare professional for appropriate dosing. For children aged 2 to 3 years weighing between 24-35 lbs, the recommended dose is 5 mL or as directed by a healthcare provider.

It is critical to adhere to the dosing guidelines and not exceed the recommended dose, as overdose can occur. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Quick medical attention is essential for both children and adults, even if no symptoms are apparent.

When administering the medication, caregivers should refer to the dosing chart to determine the correct dose based on the child's weight; if weight is not available, age may be used as a guide. It is important to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing devices to ensure accurate administration. Additionally, the product should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the insert does not provide guidance on geriatric use. The product is primarily intended for infants and children, and there are no documented 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 relevant clinical findings or recommendations. Monitoring for any potential adverse effects or interactions is advisable, as the lack of data does not preclude the possibility of differing responses in this population.

Pregnancy

The prescribing information for Infants' TYLENOL (acetaminophen) does not provide specific data regarding its use during pregnancy. There are no explicit contraindications or identified risks associated with the use of this product in pregnant individuals. Additionally, the insert does not mention any dosage modifications for pregnant patients, nor does it include special precautions related to its use during pregnancy. Healthcare professionals should consider the absence of specific information 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 product to nursing mothers due to the potential risk to the infant.

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 medical attention 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 depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is vital to follow established protocols and guidelines for the specific substance involved to ensure optimal patient outcomes.

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 understanding of the compound's potential effects 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 about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. 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 prior to use if their child has liver disease or is currently taking the anticoagulant medication warfarin.

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 and safety.

Healthcare professionals are advised to inspect the packaging carefully before use. The product should not be utilized if the carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing, as this may indicate tampering or compromised integrity. Proper handling and storage conditions are crucial to ensure the product remains safe for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)