Panadol

Description

PANADOL is an extra strength formulation containing 500 mg of acetaminophen as the active ingredient. It is indicated for the relief of pain and reduction of fever. The product is presented in a package size of 24 caplets. Each bottle features a tamper-evident seal, and it should not be used if the printed seal under the cap is missing or broken. PANADOL is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. Trademarks associated with this product are owned by or licensed to the GSK group of companies. The National Drug Code (NDC) for this product is 0135-0609-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, backache, muscular aches, and minor arthritis pain. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years 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 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 dosage and administration instructions 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.

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

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage is 8 caplets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as this can exacerbate the risk of liver injury. Additionally, consumption of three or more alcoholic beverages daily while using this product may further increase the likelihood of liver damage.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken into account prior to use. Patients with a history of liver disease should consult a healthcare provider before using this product. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain that persists beyond 10 days, fever that worsens or lasts more than 3 days, presence of redness or swelling, or the emergence of any new symptoms. These 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 with the use of acetaminophen if patients exceed the maximum daily amount of 8 caplets within a 24-hour period, take other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product 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 appear, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, individuals 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 for both adults and children, even if no signs or symptoms are initially evident.

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, patients are advised 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 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, not to exceed 8 caplets in a 24-hour period unless directed by a physician. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For adults and children 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 professional. It is crucial for elderly patients to adhere to the maximum dosage limit of 8 caplets within a 24-hour period unless otherwise instructed by a physician. Careful monitoring of symptoms and adherence to these guidelines is essential to ensure safe use in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 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 must avoid concomitant use with other medications containing acetaminophen to mitigate the risk of hepatotoxicity.

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, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment 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. The absence of symptoms does not negate the potential for serious adverse effects, and timely intervention can be vital in managing the consequences of an overdose effectively.

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 postmarketing experience details are available in the insert.

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 about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. 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 product and consult a healthcare professional if any new symptoms arise, as these may indicate a serious condition.

Patients with a history of liver disease should be encouraged to consult with their healthcare provider before using this medication. Furthermore, those who are currently taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

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 25°C (77°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 advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further 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)