Tension Headache Relief

Description

The product is a combination of acetaminophen, aspirin, and caffeine, formulated as a tablet. Acetaminophen is characterized as a white, odorless crystalline powder, while aspirin and caffeine are also presented as white crystalline powders, both odorless. The inactive ingredients include corn starch, D&C Yellow No. 10, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. The SPL code for this product is 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

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 guidance. It is imperative that patients do not exceed the directed dosage to ensure safety and efficacy.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 caplets within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients should be instructed to discontinue use immediately and seek medical assistance.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should be cautioned to limit the intake of other caffeine-containing medications, foods, and beverages during treatment, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

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

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. The Poison Control Center can be reached at 1-800-222-1222.

Patients should be instructed to discontinue use and contact their healthcare provider if any new symptoms arise, if a painful area becomes red or swollen, if pain worsens or persists 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 should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, take other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

The product contains caffeine, which is equivalent to the amount found in a cup of coffee. Patients should 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.

Patients are instructed 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.

It is also 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 doctor or pharmacist prior to use.

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 and adults 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 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 6 caplets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 noticeable signs or symptoms. Healthcare professionals are advised to contact the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. Early recognition and management of these symptoms can significantly impact the outcome. Therefore, vigilance in assessing the patient's condition is recommended until professional help is obtained.

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 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any new symptoms arise, if the painful area becomes red or swollen, or if the pain worsens or persists for more than 10 days. Furthermore, patients should be advised to seek medical advice if a fever worsens or lasts longer than 3 days, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Additionally, those taking the blood-thinning medication warfarin should seek guidance from 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 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 health 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.

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)