Childrens Tylenol

Description

Children's TYLENOL® COLD + COUGH + SORE THROAT is an oral suspension formulated for pediatric use in children aged 4 to 11 years. The product contains acetaminophen, a pain reliever and fever reducer, and dextromethorphan HBr, a cough suppressant. It is presented in a 4 fl oz (120 mL) bottle and is flavored with bubblegum to enhance palatability. The National Drug Code (NDC) for this formulation is 50580-194-01.

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, and cough. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Shake the product well before each use. The appropriate dose should be determined using the dosing chart provided below. If possible, weight should be used to determine the dose; if weight is not available, age may be used as an alternative.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The dose may be repeated every 4 hours as needed, while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period.

Dosing Chart:

• For children weighing under 36 lb (under 4 years of age): Do not use.

• For children weighing 36-47 lb (ages 4 to 5 years): Administer 5 mL.

• For children weighing 48-95 lb (ages 6 to 11 years): Administer 10 mL.

It is essential to use only the enclosed dosing cup specifically designed for this product. The use of any other dosing device is not recommended. Additionally, this product does not contain directions or complete warnings for adult use, and care should be taken to avoid overdose.

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.

• In children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a child's medication regimen, a healthcare professional should be consulted.

• In patients with a known history of allergic reactions to this product or any of its ingredients, to prevent potential severe allergic responses.

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.

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.

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, persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Emergency Medical Help 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 prompt intervention is necessary for both adults and children, even in the absence of noticeable symptoms.

Discontinuation and Consultation Caregivers should stop use and consult a healthcare provider if any of the following occur: worsening pain or cough lasting more than 5 days; fever worsening or persisting beyond 3 days; the emergence of new symptoms; presence of redness or swelling; or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires 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 advised 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.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. Patients with a known allergy to this product or any of its ingredients should also refrain from use.

Before administering this product, it is advisable to consult a healthcare provider if the patient has liver disease, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional prior to use.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if pain or cough worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, if redness or swelling occurs, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help without delay, even if no signs or symptoms are apparent.

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, which can lead to severe liver damage.

In pediatric patients, the use of this medication is contraindicated in those who are concurrently 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. The combination may lead to serious adverse effects.

Additionally, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to administering this medication to a child who is taking the anticoagulant warfarin. Monitoring may be necessary to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not be administered this product. For children aged 4 to 5 years, the recommended dose is 5 mL, while for those aged 6 to 11 years, the recommended dose is 10 mL. It is important not to exceed 5 doses within a 24-hour period. When determining the appropriate dose, weight should be used if possible; otherwise, age may be utilized. Healthcare professionals should instruct caregivers to use only the enclosed dosing cup specifically designed for this product and to avoid using any other dosing device.

Geriatric Use

There is no specific information regarding the use of Children's Tylenol Cold Plus Cough Plus Sore Throat in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for potential adverse effects and to assess the appropriateness of the dosage, as older adults may have altered pharmacokinetics and pharmacodynamics. Given the lack of targeted studies or data, individualized treatment plans should be developed, taking into account the overall health status and comorbidities of geriatric patients.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional prior to use, as there may be potential risks to the fetus. Specific studies or data regarding fetal outcomes are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned; however, it is strongly advised to seek medical advice before using 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 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.

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 safety and efficacy 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 based on the amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs. Depending on the specific circumstances, further interventions may be required to ensure patient safety and recovery.

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 and seek medical assistance immediately.

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 not to use this product 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 in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication, which is often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any uncertainty regarding the presence of an MAOI in a child's prescription, patients should seek guidance from a healthcare professional.

It is essential to inform patients that this product should not be used if their child has a history of allergic reactions to it or any of its ingredients. Patients should be instructed to discontinue use and consult a doctor if their child's pain or cough worsens or persists for more than five days, if fever worsens or lasts more than three days, or if new symptoms arise. Additionally, they should seek medical advice if there is any redness or swelling, or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Patients must be reminded to adhere strictly to the recommended dosage and to be aware of the overdose warning associated with this product. It is advisable for patients to consult a doctor before use if their child has liver disease, a persistent or chronic cough, such as that associated with asthma, or a cough that produces excessive phlegm (mucus). Furthermore, patients should be encouraged to speak with a doctor or pharmacist if their child is taking the blood-thinning medication warfarin.

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

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 counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek medical attention if pain or cough 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. Additionally, they should stop use and consult a doctor if a cough recurs or is accompanied by 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.

View product document (PDF)