Tension Headache Relief

Description

Acetaminophen, with a dosage of 500 mg per caplet, is a non-opioid analgesic used for the relief of pain. Each caplet also contains 65 mg of caffeine, which may enhance the analgesic effect of acetaminophen. The product is supplied in a package containing 15 caplets.

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.

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

This product contains acetaminophen, which poses significant risks if not used according to guidelines.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 caplets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the user consumes 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should advise patients to limit the intake of other caffeine-containing medications, foods, and beverages while using this product, as excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General Precautions Patients should consult a healthcare provider prior to use if they have a history of liver disease. Furthermore, it is advisable for individuals taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The Poison Control Center can be reached at 1-800-222-1222.

When to Stop Taking the Product Patients should 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 beyond 10 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 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, and beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients with a known allergy to acetaminophen should not use this product. Additionally, individuals with liver disease should consult a doctor prior to use. Those taking the blood-thinning medication warfarin are also encouraged to seek advice from a healthcare professional before using this product.

Patients are advised to stop use and consult a doctor 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, as these may indicate a serious condition.

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 Tension Headache Relief (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, with a maximum of 6 caplets in a 24-hour period.

Geriatric Use

There is no specific information 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety profile in these populations has not been fully established, and healthcare providers can offer guidance tailored to individual circumstances.

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 6 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications that contain 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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Quick intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to call 1-800-222-1222 for guidance and support in managing the situation.

Prompt recognition and management of overdose symptoms can significantly impact patient outcomes. Therefore, vigilance in monitoring for any potential adverse effects is essential, and appropriate medical protocols should be followed to ensure patient safety.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this medication if they have a known allergy to acetaminophen. Additionally, they should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should consult with a doctor or pharmacist.

Patients should be instructed to stop using the medication and consult a doctor if they experience any new symptoms, if the painful area becomes red or swollen, or if their pain worsens or persists for more than 10 days. Furthermore, if a fever worsens or lasts longer than 3 days, patients should seek medical advice, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this medication if they have liver disease. Additionally, patients 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 should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains important information regarding the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of symptoms. The Poison Control Center can be reached at 1-800-222-1222.

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

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)