Panadol

Description

Panadol® is formulated as EXTRA ACETAMINOPHEN, containing active ingredients acetaminophen, a pain reliever, and caffeine, a pain reliever aid. The product is presented in a package size of 24 caplets, housed in a tamper-evident bottle. A tamper warning is included, stating that the product should not be used if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. The National Drug Code (NDC) for this product is 0135-0620-01. It is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. All rights are reserved under copyright ©2016 GSK group of companies or its licensor, with trademarks owned by or licensed to the GSK group of companies.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache and muscular aches.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 caplets every 6 hours as needed for symptom relief or as directed by a healthcare professional. It is imperative that patients do not exceed a total of 8 caplets within a 24-hour period unless specifically directed by a physician.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Patients should adhere strictly to the recommended dosages and frequency 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, caffeine, or any other components of the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 8 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Patients should be instructed to discontinue use immediately and seek medical assistance if any skin reaction occurs.

Caution is warranted regarding caffeine intake. The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should be advised to limit the consumption of other caffeine-containing medications, foods, or beverages, as excessive caffeine intake may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should recommend that patients consult a physician prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever worsens or lasts longer than 3 days, redness or swelling is observed, or any new symptoms arise. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 8 caplets in 24 hours, use other drugs containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

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.

The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, on occasion, rapid heartbeat.

Patients should stop use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if any new symptoms arise, as these may indicate a serious condition.

Individuals with liver disease should consult a doctor prior to using this product. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before use.

Taking more than the recommended dose can result in 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 for both adults and children, even if no signs or symptoms are present.

Drug Interactions

Concurrent use 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.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, or as directed by a healthcare provider. It is important to note that no more than 8 caplets should be taken within a 24-hour period unless specifically directed by a doctor.

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 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 safe use during pregnancy and lactation.

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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in instances where no signs or symptoms are immediately apparent. Prompt intervention can significantly mitigate potential adverse effects associated with an 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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients not to use this medication if they have a known allergy to acetaminophen, caffeine, or any other ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience any new symptoms, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F).

To ensure the integrity of the product, it is important to close the cap tightly after each use. This practice helps maintain the quality and efficacy of the product during its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)