Panadol

Description

Panadol® Infants’ 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 3 years. It is ibuprofen-free, aspirin-free, and does not contain added sugar. The formulation features an artificial raspberry flavor and includes a dosing device for accurate administration. Each bottle contains 1.85 fl oz (54.7 mL) of the product. The packaging includes a tamper-evident feature, and it is advised not to use the product if the printed overwrap is missing or broken. Panadol® Infants’ is manufactured by GlaxoSmithKline Consumer Healthcare, L.P., located in Moon Township, PA 15108, and is made in Canada. The National Drug Code (NDC) for this product is 0135-0539-02.

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 guidelines to avoid the risk of overdose. The appropriate dose can be determined using the provided dosage chart, prioritizing weight for dosing when possible; if weight is not available, age should be used as a reference.

For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 and 35 pounds. For children under 2 years of age, consultation with a physician is required before administration.

Doses may be repeated every 4 hours as needed while symptoms persist, or as directed by a healthcare provider. 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 syringe. The use of any other dosing device is not recommended, as it may lead to inaccuracies in the administered dose.

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 pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may 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.

Prior to administration, it is essential to consult a physician if the child has a history of liver disease. Additionally, caregivers should be advised to consult a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, due to potential interactions.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child experiences any of the following: worsening pain that persists beyond 5 days, a fever that worsens or lasts more than 3 days, the presence of redness or swelling, or the emergence of any new symptoms. These signs may indicate a serious underlying condition that requires further evaluation.

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

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients may experience severe liver damage 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.

Additionally, there is an allergy alert related to acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should 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 for more than five days, if fever worsens or lasts longer than three days, if redness or swelling is observed, or if any new symptoms arise, as these may indicate a serious underlying condition.

Before using this product, it is important for patients to consult a doctor if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to use.

An overdose warning is also pertinent; taking more than the recommended dose can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential 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. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. 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 with liver disease should consult a healthcare professional prior to use. Additionally, it is important to seek advice from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

For dosing, children under 2 years of age and weighing less than 24 lbs should have their dosage determined by a healthcare provider. For children aged 2 to 3 years, weighing between 24 to 35 lbs, the recommended dosage is 5 mL.

It is crucial not to exceed 5 doses within a 24-hour period unless specifically directed by a healthcare professional. To ensure accurate dosing, the enclosed pre-marked measuring syringe should be used exclusively; other dosing devices are not recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns specifically outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when prescribing this product to women of childbearing potential and consider the lack of information when assessing the potential risks and benefits for pregnant patients. It is advisable to monitor any emerging data related to fetal outcomes as it becomes available.

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. It is recommended to monitor the infant for any adverse effects if the mother is taking this medication while breastfeeding.

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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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

No specific postmarketing experience details are provided in the insert.

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 medication if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the product. 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 medication and consult a healthcare professional.

Additionally, patients should be advised 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. For pediatric patients, it is essential to recommend that parents or guardians consult a doctor before use if their child has liver disease. Furthermore, patients should be reminded to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

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 any degradation of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor before use if the patient has liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin. Patients should be instructed to discontinue use and contact a healthcare professional if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if any redness, swelling, or new symptoms develop, as these may indicate a serious condition.

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)