Excedrin

Description

EXCEDRIN TENSION HEADACHE is a pain reliever formulation containing 500 mg of acetaminophen and 65 mg of caffeine per caplet. It is indicated for the relief of tension headaches. The product is packaged in a tamper-evident bottle containing 24 caplets. Users are advised not to use the product if the inner safety seal under the cap, imprinted with “SEALED for YOUR PROTECTION,” is broken or missing. EXCEDRIN TENSION HEADACHE is distributed by Haleon, located in Warren, NJ 07059. ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations. It is imperative that patients do not exceed the directed dosage to avoid potential adverse effects.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 6 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should advise patients to limit the use of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should not use this product if they have a known allergy to acetaminophen. It is also essential to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare provider.

Prior to use, patients with liver disease should seek medical advice. Additionally, those taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before using this product.

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

Patients are advised to discontinue use and consult a healthcare provider if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of acetaminophen. Serious reactions include severe skin reactions, which may manifest as skin reddening, blisters, or rash. Patients should be aware that severe liver damage can occur if the maximum daily dosage of 6 caplets is exceeded within a 24-hour period, if acetaminophen is taken in conjunction with other medications containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product.

Caffeine-related adverse reactions may also occur, particularly if excessive amounts are ingested. Symptoms can include nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised not to use this product if they have a known allergy to acetaminophen or if they are taking any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is recommended.

Before using this product, patients should consult a doctor if they have liver disease or if they are taking the blood-thinning medication warfarin.

Patients should discontinue use and seek medical advice if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts for more than 3 days, as these may indicate a serious condition.

Drug Interactions

The concomitant use of caffeine-containing medications, foods, or beverages should be limited while taking this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. This is to prevent the risk of acetaminophen overdose, which can lead to serious liver damage.

Additionally, caution is advised when this product is taken alongside warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety and to adjust warfarin dosage if necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin (acetaminophen, 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, with a maximum of 6 caplets in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of EXCEDRIN TENSION HEADACHE in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended 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 no specific data available regarding the excretion of this medication in 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 absence of 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, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, the risk of severe liver damage is heightened if this product is taken concurrently with other medications containing acetaminophen.

Patients with compromised liver function are advised to avoid the consumption of 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. 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 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is crucial for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, the need for quick intervention remains critical.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its integrity and efficacy.

After each use, it is essential to close the cap tightly to prevent contamination and ensure the product remains secure. Users should not utilize the product if the inner safety seal located under the cap, which is imprinted with “SEALED for YOUR PROTECTION,” is broken or missing, as this indicates potential compromise of the product's safety.

Additional Clinical Information

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

For administration, adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use, and to read all product information thoroughly, retaining the packaging for important details.

Drug Information (PDF)

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

View product document (PDF)