Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Tension Headache Relief

Last content change checked dailysee data sync status

Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 29, 2025
Manufacturer
Pioneer Life Sciences, LLC
Registration number
M013
NDC root
72090-004
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Tension Headache Relief is a medication designed to temporarily relieve minor aches and pains caused by headaches and muscular discomfort. If you're experiencing tension headaches or muscle aches, this product may help alleviate your symptoms and provide you with some comfort.

While the specific mechanism of action isn't detailed, its primary purpose is to offer quick relief from the discomfort associated with these common conditions. Always consult with a healthcare professional if you have questions about its use or if your symptoms persist.

Uses

You can use this medication to temporarily relieve minor aches and pains, such as headaches and muscular aches. It’s designed to help you feel more comfortable when you're experiencing these common discomforts.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

For adults and children aged 12 years and older, you should take 2 caplets by mouth every 6 hours. However, make sure not to exceed 6 caplets in a 24-hour period. If you have a child under 12 years old, it’s important to consult a doctor before giving them this medication.

Remember to take the caplets orally, which means you should swallow them with water. Following this schedule will help ensure you get the right amount of medication safely.

What to Avoid

It's important to use this medication safely. Keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using the medication and consult your doctor if you notice any new symptoms, if the area you're treating becomes red or swollen, if your pain worsens or lasts longer than 10 days, or if your fever gets worse or lasts more than 3 days. Your health and safety are the top priority, so don't hesitate to reach out to a healthcare professional with any concerns.

Side Effects

You should be aware that acetaminophen can cause serious skin reactions, including skin reddening, blisters, and rashes. If you notice any of these symptoms, stop using the product immediately and seek medical help. Additionally, be cautious about liver health; taking more than 6 caplets in 24 hours, using other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage.

This product contains caffeine, roughly equivalent to a cup of coffee, so it's wise to limit other sources of caffeine while using it. Too much caffeine may lead to nervousness, irritability, sleeplessness, or even a rapid heartbeat. If you experience any new symptoms, notice redness or swelling in a painful area, or if your pain or fever worsens or lasts longer than the specified time, consult your doctor. Always check with your healthcare provider if you have liver disease or are taking blood thinners like warfarin before using this product.

Warnings and Precautions

It's important to be aware of some serious warnings when using this product. First, if you experience any skin reactions such as redness, blisters, or a rash, stop using the product immediately and seek medical help. Additionally, be cautious with the amount you take; exceeding 6 caplets in 24 hours, combining it with other acetaminophen-containing medications, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. If you have liver disease or are taking the blood thinner warfarin, consult your doctor before using this product.

You should also monitor your symptoms closely. If you notice any new symptoms, if the area of pain becomes red or swollen, or if your pain lasts longer than 10 days or your fever worsens after 3 days, stop using the product and contact your doctor. Lastly, if you suspect an overdose, seek emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt attention is crucial for both adults and children.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours, but do not exceed 6 caplets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 6 caplets in a 24-hour period, as this is the maximum daily amount. Additionally, be careful not to take other medications that also contain acetaminophen, as this can increase the risk of liver damage.

If you consume 3 or more alcoholic drinks each day, you should avoid using this product altogether, as combining alcohol with acetaminophen can further harm your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety while using this medication.

Drug Interactions

It's important to be aware that taking acetaminophen (a common pain reliever) alongside warfarin (a blood thinner) can increase the effects of warfarin, which may raise your risk of bleeding. If you are using both medications, your healthcare provider will likely want to monitor your INR (International Normalized Ratio), a test that helps measure how well your blood is clotting.

Since there are no other specific drug interactions or lab test interactions noted, it's still crucial to discuss all medications and supplements you are taking with your healthcare provider. This ensures your safety and helps manage any potential risks effectively. Always keep an open line of communication about your health and medications.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain its effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the product.

Handling your product safely is crucial. Always ensure that you are in a clean environment to avoid introducing any unwanted substances. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Tension Headache Relief used for?

Tension Headache Relief is used to temporarily relieve minor aches and pains due to headaches and muscular aches.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 caplets every 6 hours, not exceeding 6 caplets in 24 hours.

What should I do if I have a child under 12 who needs this medication?

For children under 12 years, you should ask a doctor before use.

Are there any warnings associated with Tension Headache Relief?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess or with alcohol. It may also cause severe skin reactions.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Can I take Tension Headache Relief if I have liver disease?

You should ask a doctor before using this product if you have liver disease.

Is it safe to use Tension Headache Relief while pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do if I experience new symptoms while using this medication?

You should stop use and ask a doctor if any new symptoms occur, or if the painful area is red or swollen.

How should I store Tension Headache Relief?

Store Tension Headache Relief at 20°-25°C (68°-77°F) and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Tension Headache Relief (acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tension Headache Relief.
Details

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)

Description

No description information is available for the specified drug.

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

The caplets should be taken by mouth, ensuring that the specified frequency of administration is adhered to for optimal efficacy and safety.

Contraindications

There are no specific contraindications identified for this product. However, the following precautions should be observed:

  • Keep out of reach of children to prevent accidental ingestion.

  • In the event of an overdose, seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

  • Discontinue use and consult a healthcare professional if any new symptoms arise.

  • Cease use and consult a healthcare professional if the affected area becomes red or swollen.

  • Stop use and seek medical advice if pain worsens or persists for more than 10 days.

  • Consult a healthcare professional if fever worsens or lasts longer than 3 days.

Warnings and Precautions

Acetaminophen is associated with several important warnings and precautions that healthcare professionals should communicate to patients to ensure safe use.

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

Liver Warning This product contains acetaminophen, and there is a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as 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 lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Contraindications Patients should not 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, patients should consult a healthcare provider.

When to Discontinue Use Patients should be instructed 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 persists or worsens beyond 10 days, or if fever worsens or lasts longer than 3 days. These symptoms may indicate a serious underlying condition.

Pre-Use Consultation Healthcare professionals should advise patients to seek medical advice before using this product if they have liver disease. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use, as there may be potential interactions.

Emergency Situations In the case of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

Severe skin reactions have been reported in patients taking acetaminophen, characterized by symptoms such as skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage associated with this product, particularly if patients exceed the maximum recommended dosage of 6 caplets in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before use.

Caffeine is also a component of this product, and the recommended dose contains approximately the same amount of caffeine as a cup of coffee. Patients are cautioned to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

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 for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious underlying condition.

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to using this product to avoid potential interactions.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Tension Headache Relief (acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tension Headache Relief.
Details

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

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. 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients are advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

Furthermore, patients with compromised liver function should limit their alcohol intake to fewer than 3 alcoholic drinks per day while using this product. Monitoring of liver function is recommended for patients with existing liver conditions or those who consume alcohol regularly, to ensure safety and prevent potential hepatotoxicity.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and be prepared to respond appropriately in the event of an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions, including skin reddening, blisters, and rash, have been reported in association with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Additionally, reports of liver damage have been noted, particularly in cases of excessive use or concurrent use with other acetaminophen-containing products. Caffeine-related adverse effects, such as nervousness, irritability, sleeplessness, and rapid heartbeat, have also been documented. It is recommended to limit the use of caffeine-containing medications, foods, or beverages while taking this product to mitigate the potential for increased side effects.

Furthermore, new symptoms, worsening pain, or fever lasting beyond specified durations should prompt consultation with a healthcare provider, as these may indicate serious underlying conditions.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek immediate medical assistance 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 symptoms are apparent.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any new symptoms. Additionally, they should stop using the medication and seek medical advice if the affected 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 underlying condition.

It is important for patients to consult their healthcare provider before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with their 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. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. It is essential to ensure that the cap is closed tightly after each use to prevent contamination and preserve the product's quality.

Additional Clinical Information

No further data are available.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Tension Headache Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.