Childrens Tylenol

Description

Children's TYLENOL® is a chewable formulation containing acetaminophen as the active ingredient, designed for pain relief and fever reduction. Each tablet contains 160 mg of acetaminophen and is intended for use in children aged 2 to 11 years. The product is ibuprofen-free and aspirin-free, providing a suitable option for those requiring a pain and fever management solution without these ingredients.

The chewable tablets are available in a grape flavor and are packaged in a bottle containing 24 tablets. It is recommended that the tablets be chewed or crushed completely before swallowing to ensure proper administration. The National Drug Code (NDC) for this product is 50580-522-24.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. 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 pediatric patients, and specific dosing instructions must be followed to ensure safety and efficacy. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age.

Patients should chew or crush the tablets completely before swallowing; tablets should not be swallowed whole. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses in a 24-hour period. It is imperative not to exceed the recommended dosage to avoid the risk of overdose.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a physician.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 tablet.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1½ tablets.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 tablets.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2½ tablets.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 tablets.

Healthcare professionals should ensure that patients and caregivers are aware of these instructions to promote safe and effective use of the product.

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 administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, exceeding the recommended dosage 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 five 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. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare providers should instruct caregivers to consult a physician if a child experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General Precautions Prior to administration, it is essential to consult a healthcare professional if the child has a history of liver disease. Furthermore, caregivers should seek advice from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

Emergency Medical Help In the event of a skin reaction, immediate cessation of the product is necessary, and medical help should be sought without delay.

Monitoring and Follow-Up Caregivers should be advised to discontinue use and contact a healthcare provider if any of the following occur: worsening pain that lasts more than five days, worsening fever that persists for more than three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires prompt medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in other medications should consult a doctor or pharmacist. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Patients are advised to 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 occurs, as these may indicate a serious condition.

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 due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lbs should consult a doctor before use, particularly if they are under 2 years of age. For children aged 2 to 3 years weighing 24-35 lbs, the recommended dosage is 1 tablet. For those aged 4 to 5 years weighing 36-47 lbs, the dosage increases to 1½ tablets. Children aged 6 to 8 years weighing 48-59 lbs should receive 2 tablets, while those aged 9 to 10 years weighing 60-71 lbs may take 2½ tablets. For children weighing 72-95 lbs, the dosage is 3 tablets at age 11.

Dosing instructions indicate that the medication may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period. Caution is advised, as severe liver damage may occur if the maximum dosage is exceeded. Parents should consult a doctor prior to use if their child has liver disease.

There is an allergy alert associated with acetaminophen, which may lead to severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as quick medical attention is essential for children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. It is advisable to monitor these patients closely for any adverse effects and to consider potential dose adjustments based on individual patient needs and responses.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus, and further studies are needed to determine the safety profile of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to offer recommendations tailored to individual circumstances. Use during pregnancy should be approached with caution, ensuring that the benefits of treatment outweigh any potential risks to fetal outcomes.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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. 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 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 cases of overdosage, significant health risks may arise, particularly concerning liver function.

Risk of Severe Liver Damage Administration of more than five doses of acetaminophen within a 24-hour period poses a substantial risk of severe liver damage. This threshold represents the maximum recommended daily dosage for pediatric patients.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can exacerbate the risk of liver injury. Healthcare professionals should be vigilant in assessing the total daily intake of acetaminophen from all sources to prevent potential overdosage.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should consider monitoring liver function tests and may need to initiate appropriate management protocols, including the administration of N-acetylcysteine as an antidote, depending on the severity of the situation and the timing of the overdose.

Prompt recognition and intervention are critical to mitigate the risk of long-term hepatic 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 a doctor or pharmacist for clarification.

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 before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) and must be kept away from high humidity environments. Additionally, it is essential to protect the product from light exposure to maintain its integrity.

Healthcare professionals are advised to inspect the product prior to use. The product should not be used if the foil inner seal, which is imprinted with "TYLENOL," is broken or missing, as this may indicate compromised quality or safety.

Additional Clinical Information

No further data are available.

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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