Childrens Tylenol

Description

Children's TYLENOL® COLD + FLU is an oral suspension formulated for pediatric use in children aged 6 to 11 years. Each 4 fl oz (120 mL) bottle contains acetaminophen, a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The product is presented in a bubblegum flavor, designed to enhance palatability for children. The National Drug Code (NDC) for this formulation is 50580-456-01.

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 pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning provided.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart below, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup, which is specifically designed for use with this product.

Dosing should be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period.

Dosing Chart:

• For children weighing under 36 lb and under 4 years of age: do not use.

• For children weighing 36-47 lb and aged 4 to 5 years: do not use unless directed by a doctor.

• For children weighing 48-95 lb and aged 6 to 11 years: administer 10 mL.

It is imperative to use only the enclosed dosing cup and not any other dosing device to ensure accurate dosing.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Administration to induce sleepiness 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. Verify with a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's medication.

• Administration is contraindicated in children with known allergies to any ingredients in this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if a child takes more than 5 doses within a 24-hour period or if it 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. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Required for Severe Symptoms If a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General Precautions This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. Additionally, this product should not be used to induce sleepiness in children or in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks. If there is uncertainty regarding the presence of an MAOI in a child's prescription, a healthcare professional should be consulted.

This product is contraindicated in children with known allergies to any of its ingredients. Prior to use, it is advisable to consult a healthcare provider 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 that associated with asthma), cough with excessive phlegm, breathing problems (such as chronic bronchitis), or glaucoma.

Furthermore, consultation with a doctor or pharmacist is recommended if the child is taking the anticoagulant warfarin or any sedatives or tranquilizers.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Discontinuation and Medical Consultation The use of this product should be stopped and a healthcare provider consulted if any of the following occur: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days; fever worsening or lasting more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting. These symptoms may indicate a serious condition requiring medical 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 alerted to the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate discontinuation of the product and prompt medical attention are advised.

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 without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. It is contraindicated for use in children to induce sleepiness, in those taking prescription monoamine oxidase inhibitors (MAOIs), or in children with known allergies to any of the product's ingredients.

Before administering this product, it is recommended that healthcare providers be consulted if the patient has a history of 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. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use.

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 has been reported. The use of sedatives and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond five days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

Drug Interactions

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

In pediatric patients, the use of this medication is contraindicated in those who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. It is recommended that a healthcare professional be consulted prior to use in patients receiving warfarin therapy.

Additionally, the concurrent use of this medication with sedatives or tranquilizers should be approached with caution. These agents may potentiate drowsiness, and it is advisable to seek guidance from a healthcare provider before combining these treatments.

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 be administered this medication. For children aged 4 to 5 years, use is not recommended unless directed by a healthcare professional. In children aged 6 to 11 years, the recommended dosage is 10 mL, with a maximum of 5 doses allowed within a 24-hour period.

When determining the appropriate dose, weight should be used if available; otherwise, age may be utilized. Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect, and the use of sedatives or tranquilizers may exacerbate this drowsiness.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for children, even if no signs or symptoms are present.

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 lack 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 before initiating treatment, ensuring that any potential risks are appropriately managed.

Pregnancy

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

Lactation

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

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 patients 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 using this product, particularly if they have a history of liver disease. The presence of acetaminophen in this formulation necessitates caution, as severe liver damage may occur if the patient exceeds five doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage is heightened when this product is used concurrently with other medications containing acetaminophen. Therefore, careful monitoring of liver function and adherence to dosing guidelines is essential to mitigate the risk of hepatotoxicity in patients with compromised liver function.

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 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 intervention may be necessary to address any complications that arise from the overdose.

It is vital to maintain open communication with poison control and other medical professionals throughout the management process to ensure optimal care and outcomes for the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 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 whether a drug contains acetaminophen, 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 there is any uncertainty regarding the presence of an MAOI in a child's prescription, patients 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 pain, nasal congestion, or cough worsens or persists beyond five days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt immediate 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 dose 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 when this product is taken.

Patients should be encouraged 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. Furthermore, it is advisable to seek professional advice if the child is taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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. If the carton is opened or if the integrity of the carton tape or bottle wrap 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 as needed, not to exceed 5 doses within a 24-hour period. Clinicians should emphasize the importance of keeping the medication out of reach of children and advise that in the event of an overdose, immediate medical assistance should be sought or a Poison Control Center contacted at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if no symptoms are apparent.

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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