Tension Headache Relief

Description

The product identified by SPL code 34089-3 is indicated for the relief of tension headaches. It is formulated to provide effective management of headache symptoms associated with tension.

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 tablets every 6 hours, with a maximum dosage of 6 tablets 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

This product contains acetaminophen, which poses a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is limited to 6 tablets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen and should avoid consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Caution is warranted regarding the caffeine content of this product, which is comparable to that found in a standard cup of coffee. Patients should be advised to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as 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. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to 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.

Patients should be advised to discontinue use and contact their healthcare provider if any new symptoms arise, if the 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

Severe liver damage may occur in patients who exceed the maximum daily dosage of six tablets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three 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 product contains a caffeine dosage comparable to that of a standard cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are instructed to stop use 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 intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Prior to using this product, patients with liver disease should seek medical advice. Additionally, individuals taking the blood-thinning medication warfarin are encouraged to consult a doctor or pharmacist before use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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 tablets every 6 hours, with a maximum of 6 tablets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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. 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Liver Damage Taking more than 6 tablets within a 24-hour period, which is the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption during treatment and consider this factor when evaluating a patient's risk profile.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are essential components of management.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing the importance of prompt attention for both adults and children, even if no symptoms are apparent. The contact number for the Poison Control Center is 1-800-222-1222.

Patients should be informed not to use the medication if they have a known allergy to acetaminophen. It is also crucial to instruct patients to avoid using this medication in conjunction with any other products that contain acetaminophen, whether prescription or over-the-counter. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist.

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

Patients with liver disease should be instructed to consult a doctor before using this medication. Furthermore, those 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°–25°C (68°–77°F) to maintain its efficacy and safety.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Healthcare professionals are advised to read all product information thoroughly before use to ensure proper handling and administration.

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 if no symptoms are apparent (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)