Acetaminophen/Caffeine

Description

No relevant information is available for SPL code 34089-3.

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 aged 12 years and over are instructed to take 2 caplets every 6 hours, with a maximum dosage of 8 caplets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a known allergy to acetaminophen. Additionally, it should not be used concurrently with any other medications that contain acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the maximum daily dosage is 8 tablets within a 24-hour period. Patients must be cautioned against taking this product in conjunction with other medications containing acetaminophen or consuming 3 or more alcoholic drinks daily while using this product.

Aspirin, another component of this formulation, may induce severe allergic reactions. Symptoms can include hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen may lead to severe skin reactions characterized by skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Caffeine is also present in the recommended dosage of this product, which is comparable to the caffeine content of a standard cup of coffee. Patients should be advised to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption 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. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin.

In cases of 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 new symptoms arise, if a painful area becomes red or swollen, if pain persists or worsens beyond 10 days, or if fever intensifies or lasts longer than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Severe liver damage is a significant concern associated with the use of this product, particularly in patients who exceed the maximum daily dosage of 8 tablets within a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the product.

Allergic reactions to aspirin can occur, potentially leading to severe symptoms such as hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

Caffeine is also a component of this product, and the recommended dosage contains approximately the same amount of caffeine as a standard cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should not use this product if they are allergic to acetaminophen or if they are taking any other medications that contain acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional.

Before using this product, patients with liver disease should seek medical advice. Additionally, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a healthcare professional 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 worsens or lasts for more than 3 days, as these may indicate a serious condition.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Tension Headache Relief. 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 8 caplets in a 24-hour period. Caution is advised when administering to younger children, and appropriate medical guidance is essential.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 patients 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 be advised of the potential risks associated with the use of this product, particularly due to the presence of acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period. This maximum dosage should not be exceeded under any circumstances, and patients should be cautioned against the concurrent use of other medications containing acetaminophen.

Additionally, patients with compromised liver function who consume three or more alcoholic drinks daily should consult a healthcare professional prior to using this product, as this may further increase the risk of liver damage. It is recommended that patients with liver disease seek medical advice before initiating treatment to ensure safety and appropriate management. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to mitigate potential adverse effects.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, vigilance and timely action are essential in managing potential overdose situations 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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about 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 in the absence of noticeable signs or symptoms, the need for quick intervention remains critical.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to ensure that the imprinted safety seal under the cap is intact before use. If the seal is broken or missing, the product should not be used. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should obtain medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)