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Tension Headache Relief

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This product has been discontinued

Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
May 31, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet, Coated
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 2021
Label revision date
May 31, 2021
Manufacturer
Safrel Pharmaceuticals, LLC.
Registration number
part343
NDC root
71309-105
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

Acetaminophen 500mg and Caffeine 65mg is a medication designed to provide relief from tension headaches. It works by temporarily alleviating minor aches and pains associated with headaches and muscular discomfort. This combination of ingredients helps to ease the discomfort you may experience during a tension headache, allowing you to feel more comfortable and focused.

If you're looking for a solution to manage your headache symptoms, this medication may be a suitable option to consider. Always consult with a healthcare professional for personalized advice and recommendations.

Uses

You can use this medication for the temporary relief of 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

When taking this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. If you are an adult or a child aged 12 years and older, you should take 2 tablets every 6 hours. However, make sure not to exceed 6 tablets in a 24-hour period.

If the patient is a child under 12 years old, it's best to consult a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage tailored to their needs. Always remember to stick to the guidelines to avoid any potential risks.

What to Avoid

It's important to be cautious when using this medication. You should not use it in combination with any other drug that contains acetaminophen, whether it's a prescription or over-the-counter medication. If you're unsure about the medications you're taking, please consult with your doctor or pharmacist before using this product.

Additionally, be aware that this medication may have potential for abuse or misuse, which can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using this medication in ways not prescribed. Your safety is the top priority, so don't hesitate to ask questions if you're uncertain about anything related to your treatment.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It contains acetaminophen, which can lead to severe liver damage if you exceed 6 tablets in 24 hours, take it with other acetaminophen-containing products, or consume 3 or more alcoholic drinks daily while using it. Additionally, the product has a caffeine content similar to a cup of coffee, so it's wise to limit other sources of caffeine to avoid symptoms like nervousness, irritability, sleeplessness, and rapid heartbeat.

If you notice any new symptoms, if your symptoms do not improve or worsen, or if the area of pain becomes red or swollen, you should stop using the product and consult a doctor. Also, seek medical advice if your pain lasts more than 10 days or if your fever persists for more than 3 days. If you have liver disease or are taking the blood thinner warfarin, it's important to talk to your doctor before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 6 tablets in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that the recommended dose has about as much caffeine as a cup of coffee, so it's wise to limit other caffeine sources to avoid side effects like nervousness, irritability, sleeplessness, and rapid heartbeat.

If you have liver disease, consult your doctor before using this product. In case of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if you don't notice any symptoms. You should also stop using the product and call your doctor if you experience any new symptoms, if your symptoms worsen or do not improve, if the painful area becomes red or swollen, if pain lasts more than 10 days, or if fever worsens or lasts more than 3 days.

Overdose

Taking too much of this product can lead to serious liver damage. You should be aware that consuming more than 6 tablets in a 24-hour period, which is the maximum recommended amount, significantly increases your risk of harm. Additionally, combining this product with other medications that contain acetaminophen (a common pain reliever) can also result in severe liver damage.

If you regularly drink 3 or more alcoholic beverages each day while using this product, you are at an even higher risk for liver issues. It's important to monitor your intake and be cautious about how you use this medication. If you suspect an overdose or experience symptoms such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes), seek medical help immediately. Always prioritize your health and consult a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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

When it comes to using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, but you should not exceed 6 tablets in a 24-hour period.

If your child is under 12 years old, it's crucial to consult a doctor before giving them this medication. This ensures their safety and helps determine the appropriate treatment for their needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory).

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 6 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount you should not exceed. Additionally, avoid using other medications that also contain acetaminophen, as this can increase your risk of liver injury.

It's also crucial to limit alcohol consumption to fewer than 3 drinks per day while using this product, as drinking alcohol can further strain your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety when using medications.

Drug Interactions

It's important to talk to your doctor or pharmacist if you're taking warfarin, a blood-thinning medication, as it may interact with other treatments. Additionally, while using this product, you should limit your intake of caffeine from medications, foods, or drinks. Too much caffeine can lead to feelings of nervousness, irritability, trouble sleeping, and sometimes a fast heartbeat.

You should also avoid using this product alongside any other medications that contain acetaminophen, whether they are prescribed or available over-the-counter. Always discuss your current medications and any potential interactions with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, please check that the safety seal under the cap is intact. If the seal is broken or tampered with, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, but do not exceed 6 tablets in a 24-hour period. If the patient is under 12 years old, it’s important to consult a doctor for the appropriate dosage.

FAQ

What is Acetaminophen 500mg and Caffeine 65mg used for?

It is used for the temporary relief of minor aches and pains due to headaches and muscular aches.

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

You should take 2 tablets every 6 hours, not exceeding 6 tablets in 24 hours.

What should children under 12 do?

Children under 12 should ask a doctor before use.

Are there any warnings associated with this product?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess or with other acetaminophen-containing drugs.

What should I do if I experience new symptoms or if my pain worsens?

You should stop using the product and ask a doctor if any new symptoms appear or if your pain lasts for more than 10 days.

Can I use this product if I have liver disease?

You should ask a doctor before use if you have liver disease.

What should I do in case of overdose?

Get medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Is there a caffeine warning?

Yes, the product contains caffeine, which can cause nervousness and irritability if consumed in excess.

Where can I find more information about this product?

You can visit the website www.safrel.com for more information.

Packaging Info

Below are the non-prescription pack sizes of Tension Headache Relief (acetaminophen 500mg). 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

Tension Headache Relief is a pharmaceutical formulation containing active ingredients of acetaminophen at a dosage of 500 mg and caffeine at 65 mg. This product is designed to provide relief from tension headaches and is comparable to the active ingredients found in Excedrin® Tension Headache.

The product is distributed by Safrel Pharmaceuticals, LLC, located in Bridgewater, NJ 08807. For further information, the company’s website is available at www.safrel.com.

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 advised to take 2 tablets every 6 hours, ensuring that the total dosage does not exceed 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. It is imperative that the recommended dosage is not exceeded to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. Healthcare professionals should advise patients to consult a doctor or pharmacist before combining this product with any other medications to ensure safety.

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 following guidelines to mitigate the risk of liver injury:

  • Do not exceed 6 tablets within a 24-hour period, as this is the maximum daily dosage.

  • Avoid concurrent use with other medications that contain acetaminophen.

  • Limit alcohol consumption to fewer than 3 drinks per day while using this product.

Caution is also warranted regarding caffeine intake. 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 use 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.

Patients with a history of liver disease should consult a healthcare provider prior to using this product to ensure safety and appropriateness of treatment.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur:

  • The emergence of new symptoms.

  • Existing symptoms do not improve or worsen.

  • The painful area exhibits redness or swelling.

  • Pain intensifies or persists for more than 10 days.

  • Fever worsens or lasts longer than 3 days.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver and caffeine.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, 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-related adverse reactions may arise, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine intake can lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Therefore, patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients should discontinue use and seek medical advice if any new symptoms appear, if symptoms do not improve or worsen, 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.

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

Drug Interactions

Patients taking this product should exercise caution when using warfarin, a blood-thinning medication. It is advisable to consult a healthcare professional, such as a doctor or pharmacist, to assess potential interactions and necessary monitoring.

Caution is also recommended regarding the consumption of caffeine-containing medications, foods, or beverages. Excessive intake of caffeine may lead to adverse effects, including nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Therefore, limiting caffeine consumption while using this product is advised.

Additionally, this product should not be used concurrently with any other medications containing acetaminophen, whether prescription or nonprescription. This precaution is essential to avoid the risk of acetaminophen overdose and associated complications.

Packaging & NDC

Below are the non-prescription pack sizes of Tension Headache Relief (acetaminophen 500mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tension Headache Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 2 tablets every 6 hours, with a maximum of 6 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before administration.

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 should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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 of 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. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of liver function and adherence to the recommended dosage guidelines is essential to minimize the risk of severe liver damage. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment.

Overdosage

Overdosage of this product can result in significant health risks, particularly severe liver damage. Healthcare professionals should be aware of the following critical points regarding overdosage.

Risk Factors for Severe Liver Damage Severe liver damage may occur if the patient exceeds the maximum recommended dosage of 6 tablets within a 24-hour period. It is essential to monitor the total intake of the product, as exceeding this limit poses a serious risk to liver health.

Additionally, the concomitant use of this product with other medications containing acetaminophen can exacerbate the risk of liver damage. Healthcare providers should advise patients to avoid combining these substances to mitigate potential adverse effects.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. It is crucial for healthcare professionals to counsel patients on the dangers of alcohol consumption in conjunction with this medication.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should assess the patient's condition and consider appropriate management strategies, which may include monitoring liver function and providing supportive care as necessary.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdosage. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. It is recommended that patients consult with a doctor or pharmacist before using this medication alongside any other drugs if they are uncertain.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any new symptoms arise. Additionally, patients should be advised to stop using the medication and seek medical advice if their symptoms do not improve or if they worsen. It is important to inform patients to stop use and contact a doctor if the area experiencing pain becomes red or swollen, if the pain intensifies, or if it persists for more than 10 days. Furthermore, patients should be cautioned to seek medical advice if a fever worsens or lasts longer than 3 days.

Patients with liver disease should be advised to consult a doctor before using this medication. Lastly, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is imprinted or compromised.

For optimal storage, the product must be kept at a controlled room temperature ranging from 20° to 25°C (68° to 77°F). Proper adherence to these storage conditions is crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children 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. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, 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)

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

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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.