Tylenol for Children Plus Adults

Description

Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever, containing 160 mg of acetaminophen per 5 mL. This product is presented in an 8 fl oz (240 mL) bottle and features a cherry flavor. It is designed for use in individuals aged 2 years and older. The formulation is free of dyes, alcohol, ibuprofen, aspirin, parabens, and high fructose corn syrup, ensuring a dye-free product suitable for a wide range of patients.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with various conditions. These conditions include the common cold, influenza, headache, sore throat, toothache, muscular aches, backache, minor pain of arthritis, and premenstrual and menstrual cramps.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid overdose. Prior to administration, the product must be shaken well.

For children aged 2 years to under 12 years, the appropriate dose should be determined using the following guidelines. If possible, weight should be used for dosing; otherwise, age may be utilized. The child protective cap should be removed, and the dose should be squeezed into the provided dosing cup. Dosing may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period unless directed by a physician. Additionally, this medication should not be administered for more than 5 consecutive days unless advised by a healthcare professional.

Dosage Chart for Children:

• Under 24 lbs (under 2 years): Consult a physician.

• 24-35 lbs (2-3 years): 5 mL.

• 36-47 lbs (4-5 years): 7.5 mL.

• 48-59 lbs (6-8 years): 10 mL.

• 60-71 lbs (9-10 years): 12.5 mL.

• 72-95 lbs (11 years): 15 mL.

• Or as directed by a physician.

For adults and children aged 12 years and over, the recommended dosage is 20 mL (equivalent to two 10 mL doses) every 4 hours while symptoms persist. The dosing cup should be filled to the 10 mL line twice for accurate dosing. The maximum allowable dosage is 5 doses (100 mL) within a 24-hour period unless otherwise directed by a healthcare provider. This medication should not be taken for more than 10 consecutive days unless instructed by a physician.

It is imperative to use only the enclosed dosing cup specifically designed for this product. The use of any other dosing device is not recommended.

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

• Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum daily amount is limited to 5 doses within the same timeframe. Caution is advised when this product is used in conjunction with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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 occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Recommendations Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease or if a child is experiencing pain due to arthritis. Furthermore, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Dosage Adherence It is crucial that users adhere strictly to the recommended dosage to avoid overdose.

In the event of an overdose, immediate medical attention is necessary. Patients should 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.

Monitoring Symptoms Patients should discontinue use and consult a doctor if any of the following occur: pain worsens or persists beyond 10 days in adults, pain lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

A sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are cautioned against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Before using this product, patients with liver disease or children experiencing pain due to arthritis should seek medical advice. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

While using this product, it is imperative that patients do not exceed the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists for more than 10 days in adults, more than 5 days in children under 12 years, or if fever worsens or lasts more than 3 days. The emergence of new symptoms or the presence of redness or swelling may indicate a serious condition, necessitating medical evaluation.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years to under 12 years should have their dosage determined using the following guidelines. When possible, dosing should be based on weight; if weight is not available, age may be used as a reference.

For children weighing under 24 lbs (under 2 years), consultation with a doctor is advised. The recommended doses for children based on weight and age are as follows:

• 24-35 lbs (2-3 years): 5 mL

• 36-47 lbs (4-5 years): 7.5 mL

• 48-59 lbs (6-8 years): 10 mL

• 60-71 lbs (9-10 years): 12.5 mL

• 72-95 lbs (11 years): 15 mL

Pediatric patients should not exceed 5 doses in a 24-hour period unless directed by a healthcare professional. Additionally, the medication should not be used for more than 5 consecutive days without medical advice. If pain worsens or persists for more than 5 days in children under 12 years, use should be discontinued, and a doctor should be consulted.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 using this product. The presence of liver disease may necessitate caution due to the potential for adverse effects.

This product contains acetaminophen, which is associated with the risk of severe liver damage. Adults should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, as exceeding this limit may lead to significant hepatic injury.

Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. It is advisable for patients with compromised liver function to adhere strictly to recommended dosages and to discuss their alcohol consumption with their healthcare provider to mitigate potential risks. Regular 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 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 of an overdose 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 during the course of treatment.

It is vital to maintain open communication with poison control and other medical professionals to ensure the best possible outcomes for patients experiencing an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. In instances where a skin reaction occurs, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Patients should be advised 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 whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. They should be instructed to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 10 days in adults, worsening pain that lasts more than 5 days in children under 12 years, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dose, including the potential for overdose. Patients with liver disease should be advised to consult a doctor before using this product. Additionally, it is recommended that parents or guardians of children with arthritis pain seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist to avoid potential interactions.

Storage and Handling

The product is supplied in a secure carton, which must remain unopened to ensure integrity. It is essential to verify that the bottle wrap imprinted with “TYLENOL” is intact; do not use the product if this wrap is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and adherence to these storage conditions are crucial to preserve the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)