Childrens Tylenol

Description

Children's TYLENOL® COLD + FLU is an oral suspension formulated for pediatric use in children aged 6 to 11 years. The product contains acetaminophen as a pain reliever and fever reducer, chlorpheniramine maleate as an antihistamine, dextromethorphan HBr as a cough suppressant, and phenylephrine HCl as a nasal decongestant. It is presented in a grape flavor and is available in a 4 fl oz (120 mL) bottle. The National Drug Code (NDC) for this formulation is 50580-299-01.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, cough, stuffy nose, sneezing, and runny nose. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in children aged 6 years and older, with specific dosing based on weight. Healthcare professionals should refer to the dosing chart to determine the appropriate dose.

Before administration, the product must be shaken well. The child protective cap should be removed, and the prescribed dose should be squeezed into the enclosed dosing cup, which is specifically designed for use with this product. It is crucial to use only the provided dosing cup and not any other dosing device.

For children weighing between 48 to 95 pounds (ages 6 to 11 years), the recommended dose is 10 mL. Dosing should be repeated every 4 hours as needed while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period.

For children under 36 pounds or under 4 years of age, the product should not be used. For children weighing between 36 to 47 pounds (ages 4 to 5 years), the product should only be administered if directed by a physician.

Healthcare professionals should ensure that caregivers are aware of the overdose warning and the importance of adhering to the recommended dosing guidelines.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug 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.

• Administration for the purpose of inducing sleep in children is not recommended.

• Use in children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication is contraindicated, as this may lead to serious interactions. Verification of the presence of an MAOI in a child's prescription should be conducted with a healthcare professional.

• The product should not be used in children with known allergies to any of its ingredients.

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 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.

Allergy Alert Acetaminophen may lead to 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.

Consultation Prior to Use Healthcare providers should recommend consulting a physician before administering this product to children with any of the following conditions:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Persistent or chronic cough, particularly in cases associated with asthma

• Cough accompanied by excessive phlegm (mucus)

• Breathing problems, such as chronic bronchitis

• Glaucoma

Furthermore, it is advisable to consult a doctor or pharmacist if the child is currently taking blood-thinning medications, such as warfarin, or sedatives and tranquilizers.

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

Discontinuation of Use Healthcare providers should advise caregivers to stop administering this product and seek medical advice if any of the following occur:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, nasal congestion, or cough lasting more than 5 days

• Fever that worsens or persists beyond 3 days

• Presence of redness or swelling

• Emergence of new symptoms

• Recurrence of cough, particularly if accompanied by rash or headache lasting longer than expected

These symptoms 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 in 24 hours or who take the product in conjunction with other drugs containing acetaminophen. Patients should be aware that acetaminophen may cause severe skin reactions, which can 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is also contraindicated for use in children to induce sleep, in those taking a prescription monoamine oxidase inhibitor (MAOI), or within two weeks of stopping such medication. Additionally, it should not be administered to children with known allergies to any of the product's ingredients.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as occurs with asthma), cough associated with excessive phlegm, a breathing problem (such as chronic bronchitis), or glaucoma. Furthermore, it is advisable to seek guidance from a healthcare professional if the child is taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

While using this product, patients should adhere strictly to the recommended dosage to avoid overdose. Notably, excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The use of sedatives and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days, or if fever worsens or lasts more than three days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache that lasts should also prompt immediate medical consultation, as these may indicate a serious condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

In pediatric patients, the use of this medication is contraindicated in those who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Caution is advised when considering the use of this medication in children who are concurrently taking warfarin, a blood-thinning agent. It is recommended to consult a healthcare professional, such as a doctor or pharmacist, prior to use to assess the risk of potential interactions and the need for monitoring.

Additionally, the concurrent use of this medication with sedatives or tranquilizers should be approached with caution. These agents may enhance drowsiness, and it is advisable to seek guidance from a healthcare professional before use to ensure safe administration and monitoring of sedation levels.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Tylenol (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to 5 years, use is not recommended unless directed by a healthcare professional. The recommended dose for children aged 6 to 11 years is 10 mL, with a maximum daily limit of 5 doses within a 24-hour period.

Caution is advised as excitability and marked drowsiness may occur, particularly in pediatric patients. Parents and caregivers should consult a doctor if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as occurs with asthma), cough associated with excessive phlegm, or any breathing problems such as chronic bronchitis.

Additionally, it is important to consult a doctor or pharmacist before use if the child is taking warfarin, sedatives, or tranquilizers. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Tylenol Cold Plus Flu, as the drug insert does not provide data on geriatric use. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population.

Due to the absence of specific clinical findings or dosage adjustments for elderly patients, it is advisable to monitor for efficacy and adverse effects closely. Providers should assess the overall health status and comorbidities of geriatric patients to ensure safe and effective use of the medication.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. While potential risks to the fetus are not specified, caution is advised. There are no specific dosage modifications for pregnant individuals. It is recommended that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which can lead to severe liver damage. It is critical that patients do not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of liver toxicity.

Before administering this product, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 of an overdose 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.

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 events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions have been noted, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in pediatric populations. Marked drowsiness is another noted effect, which may be exacerbated by the concurrent use of sedatives and tranquilizers.

Healthcare professionals are advised to recommend discontinuation of the product and consultation with a physician if patients experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than five days, fever persisting beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual.

In cases of overdose, immediate medical attention is crucial, and individuals should contact a Poison Control Center without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used in conjunction with any other medication containing 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.

Patients should be cautioned against using this product to induce sleepiness in children. Additionally, it should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are unsure whether their child's prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients must be informed to discontinue use and consult a doctor if their child experiences nervousness, dizziness, or sleeplessness. They should also be advised to stop use and seek medical advice if symptoms such as pain, nasal congestion, or cough worsen or persist beyond five days, or if fever worsens or lasts more than three days. Redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage due to the risk of overdose. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. The use of sedatives or tranquilizers may enhance drowsiness, and patients should be advised to consult a doctor before use if their child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), cough with excessive phlegm, breathing problems (such as chronic bronchitis), or glaucoma.

Finally, patients should be encouraged to consult a doctor or pharmacist if their child is taking the blood-thinning medication warfarin or any sedatives or tranquilizers before using this product.

Storage and Handling

The product is supplied in a carton that must remain sealed until use. 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 is not opened and that the carton tape or bottle wrap imprinted with "TYLENOL" is intact and unbroken prior to use. If the carton is opened or if the integrity of the packaging is compromised, the product should not be used.

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 to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as asthma), cough with excessive phlegm, breathing problems (such as chronic bronchitis), or glaucoma. Additionally, it is important to seek advice from a doctor or pharmacist if the patient is taking warfarin or any sedatives or tranquilizers. Patients should adhere to the recommended dosage to avoid overdose, as excitability may occur, particularly in children, and marked drowsiness may result, especially when combined with sedatives or tranquilizers. They should discontinue use and consult a doctor if they experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days, fever lasting more than 3 days, redness or swelling, new symptoms, or a cough that returns with a rash or persistent headache.

Drug Information (PDF)

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

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