Panadol

Description

Panadol® Children’s is a liquid formulation containing acetaminophen at a concentration of 160 mg per 5 mL. This product is designed for the relief of pain and reduction of fever in children aged 2 to 11 years. It is ibuprofen-free, aspirin-free, and does not contain added sugar. The formulation features an artificial raspberry flavor and is packaged in a 4 fl oz (118 mL) bottle. A tamper evident feature is included; do not use if the printed overwrap is missing or broken. Panadol, the Beacon design, and the Bear design are registered trademarks of the GSK group of companies. This product is manufactured by GlaxoSmithKline Consumer Healthcare, L.P., located in Moon Township, PA 15108, and is made in Canada.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with colds, flu, headache, 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

The appropriate dose should be determined using the provided dosage chart, prioritizing weight for dosing when possible; if weight is not available, age may be used as a guide.

For patients under 2 years of age, consultation with a physician is required prior to administration. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 and 35 pounds. For children aged 4 to 5 years, the dose increases to 7.5 mL for those weighing between 36 and 47 pounds. Children aged 6 to 8 years should receive 10 mL if they weigh between 48 and 59 pounds, while those aged 9 to 10 years should be given 12.5 mL for weights ranging from 60 to 71 pounds. Finally, for children aged 11 years, the recommended dose is 15 mL for those weighing between 72 and 95 pounds.

Doses may be repeated every 4 hours as needed while symptoms persist, or as directed by a healthcare provider. However, it is imperative that no more than 5 doses are taken within a 24-hour period unless specifically instructed by a physician.

To ensure accurate dosing, patients should utilize only the enclosed pre-marked measuring cup and refrain from using any other dosing devices. Adherence to these guidelines is crucial to avoid the risk of overdose.

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.

Additionally, this product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen.

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 immediately and seek medical assistance.

Healthcare professionals should advise caregivers to consult a physician prior to administration if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, fever that persists or worsens beyond 3 days, presence of redness or swelling, or the emergence of any new symptoms. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take this product concurrently with other medications containing acetaminophen. It is crucial for caregivers to monitor dosage closely to prevent overdose.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Patients are advised to stop using the product and consult a healthcare professional if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if redness or swelling is observed, or if any new symptoms arise. These signs may indicate a serious underlying condition that requires medical evaluation.

Before using this product, caregivers should consult a doctor if the child has a history of liver disease. Furthermore, it is recommended to seek advice from a healthcare provider or pharmacist if the child is currently taking the blood-thinning medication warfarin, as interactions may occur.

In the event of an overdose, which can lead to serious health complications, immediate medical attention is essential. Caregivers should contact a Poison Control Center or seek emergency medical help, even if no signs or symptoms are initially apparent. Quick intervention is critical in such cases.

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. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. 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 Panadol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age weighing less than 24 lbs should consult a doctor before use. For children aged 2 to 3 years weighing between 24 and 35 lbs, the recommended dosage is 5 mL. For those aged 4 to 5 years weighing 36 to 47 lbs, the dosage increases to 7.5 mL. Children aged 6 to 8 years weighing 48 to 59 lbs should receive 10 mL, while those aged 9 to 10 years weighing 60 to 71 lbs may take 12.5 mL. For children aged 11 years weighing between 72 and 95 lbs, the dosage is 15 mL.

Severe liver damage may occur if a pediatric patient takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical help should be sought. Prior to use, a doctor should be consulted if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents and caregivers should monitor for worsening pain lasting more than 5 days, fever lasting more than 3 days, or the presence of redness or swelling, as these may indicate a serious condition. In the event of an overdose, immediate medical attention is critical, even if no signs or symptoms are present.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to inquire about any pre-existing liver conditions in pregnant patients, as the use of this product may pose additional risks. Furthermore, caution is warranted if the patient is concurrently taking anticoagulants such as warfarin; consultation with a doctor or pharmacist is recommended prior to use.

While specific data regarding the use of this product during pregnancy is not provided, it is critical to note that exceeding the recommended dosage can lead to serious health complications. In the event of an overdose, immediate medical attention is necessary, even if the patient does not exhibit any signs or symptoms. Healthcare professionals should ensure that pregnant patients are aware of these risks and the importance of adhering to recommended dosages.

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 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 use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as quick medical attention can significantly impact the outcome, even if the patient does not exhibit any immediate signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate any potential adverse effects associated with the overdose.

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 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 that they should not use this product in conjunction with any other medications containing 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 made aware that they must not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than five days. Similarly, if a fever worsens or lasts longer than three days, patients should stop using the product and consult a healthcare professional.

Additionally, patients should be informed to stop use and contact a doctor if they notice any redness or swelling, or if any new symptoms arise, as these may indicate a serious condition. It is also crucial to advise patients to consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be encouraged to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures below 30°C (86°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to higher temperatures, which may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)