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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
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 31, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
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 31, 2022
Manufacturer
Hi-Tech Nutraceuticals, LLC
Registration number
part343
NDC root
69732-007
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

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary for you. If you have specific information about a drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects. If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

It seems that there are no specific details available regarding how to take or apply the medication, including the dosage, method, or frequency. This means that you should consult your healthcare provider or the medication's packaging for guidance on how to use it properly. They will provide you with the necessary instructions tailored to your individual needs. Always follow their advice to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should not use it if you have any specific contraindications, although none are detailed in the provided information. Additionally, if you experience any adverse effects or have concerns while using the medication, it's crucial to stop use immediately.

While there are no specific risks mentioned regarding abuse, misuse, or dependence (which refers to a condition where your body becomes reliant on a substance), always use medications as directed by your healthcare provider. If you have any questions or uncertainties, please consult with your doctor for personalized advice.

Side Effects

It's important to be aware of potential side effects when using this medication. Some individuals may experience serious reactions, and if you notice any unusual symptoms, it's crucial to stop using the medication and consult your doctor immediately. In cases of overdose, seek medical attention right away, as this can lead to severe health issues.

If you have any concerns or questions about how this medication may affect you, don't hesitate to ask your doctor or pharmacist for guidance. They can provide you with the information you need to use the medication safely.

Warnings and Precautions

It's important to be aware of certain warnings when using this medication. If you experience any unusual symptoms or side effects, you should stop taking the medication and call your doctor immediately for guidance.

There are no specific general precautions or laboratory tests required for safe use of this medication, which means you can use it without the need for regular monitoring. However, always stay alert to how your body responds and reach out to your healthcare provider if you have any concerns.

Overdose

If you suspect an overdose, it’s important to act quickly. Signs of an overdose can include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms in yourself or someone else, seek immediate medical help.

In the event of an overdose, do not wait for symptoms to worsen. Call emergency services or go to the nearest hospital right away. Providing timely assistance can be crucial for recovery. Always keep medications out of reach and follow prescribed dosages to prevent accidental overdoses.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with your healthcare professional before using this medication. They can provide guidance on any potential risks and help you make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to note that the safety and effectiveness of this product for children have not been established. If you are considering using it for a child under 12 years old, you should consult a physician (a medical doctor) first. This ensures that you receive the best advice tailored to your child's specific health needs. Always prioritize your child's safety by seeking professional guidance before giving them any medication.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of your medication. Your healthcare provider will monitor your kidney function closely, which includes checking your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular renal function tests are essential to ensure your kidneys are working properly, especially if your kidney function is compromised. If you have severe renal impairment, you will require special monitoring to manage your treatment safely. Always discuss any concerns with your healthcare provider to ensure the best care for your condition.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health safely.

Storage and Handling

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you can store it in a standard environment without any special requirements.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about proper use or safety, don’t hesitate to reach out for more information.

Additional Information

No further information is available.

FAQ

What should I do if I need to stop using this medication?

You should stop use and consult your doctor.

Are there any contraindications for this medication?

No specific contraindications are mentioned.

Is this medication safe for use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before use.

Can this medication be used in children?

Pediatric use has not been established, and you should consult a physician before administering it to children under 12 years of age.

What should I do if I have renal impairment?

If you have renal impairment, you may need a reduced dose, and your creatinine clearance should be monitored regularly.

Are there any specific warnings associated with this medication?

Yes, there are warnings, but specific details are not provided in the text.

Is there any information on drug interactions?

No specific drug interactions are mentioned.

What should I do in case of an overdose?

Specific instructions regarding overdose are not provided.

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

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

There is currently no specific dosage and administration information available for the product. Healthcare professionals are advised to refer to the prescribing information or relevant clinical guidelines for detailed instructions regarding the appropriate dosage, route of administration, and frequency of use. It is essential to consider individual patient factors and clinical judgment when determining the appropriate dosing regimen.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to refrain from use in any situation where the product may not be appropriate. Additionally, if any adverse effects or unexpected reactions occur, discontinue use immediately.

Warnings and Precautions

Patients should be aware of the following warnings associated with the use of this medication. It is crucial to adhere to these guidelines to ensure safe and effective treatment.

Warnings Healthcare professionals should refer to the accompanying image for detailed warnings related to the medication. These warnings are essential for identifying potential risks and ensuring patient safety.

Stop Taking and Call Your Doctor In the event of adverse reactions or concerning symptoms, patients are advised to discontinue use immediately and consult their healthcare provider. Detailed instructions can be found in the referenced image.

General Precautions Currently, there are no specific general precautions outlined for the use of this medication.

Laboratory Tests No laboratory tests are required or suggested for the safe use of this medication. Regular monitoring is not necessary, but healthcare providers should remain vigilant for any changes in the patient's condition.

It is imperative that healthcare professionals remain informed about these warnings and precautions to provide optimal care and guidance to their patients.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this medication. In the event of an overdose, immediate medical attention is required. Patients are advised to stop use and seek medical advice if they experience any concerning symptoms or reactions.

It is recommended that patients consult with a doctor or pharmacist for guidance regarding the use of this medication, particularly if they have pre-existing conditions or are taking other medications that may interact. This precaution is essential to ensure safe and effective use of the product.

Overall, careful monitoring and communication with healthcare professionals are crucial for managing any adverse reactions that may arise during treatment.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

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 use has not been established for this product. It is recommended that a physician be consulted prior to administration in children under 12 years of age.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits of treatment during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to monitor creatinine clearance in these patients to assess renal function accurately. Regular renal function tests should be conducted in patients with compromised kidney function to ensure appropriate dosing and safety. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with the medication.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, it is crucial for healthcare professionals to be aware of the potential symptoms and recommended management strategies.

Symptoms of Overdosage Patients experiencing an overdose may present with a range of symptoms that can vary in severity. Common manifestations include, but are not limited to, respiratory depression, altered mental status, and cardiovascular instability. It is essential to monitor the patient closely for any signs of these symptoms, as they may indicate a serious medical condition requiring immediate intervention.

Recommended Actions Upon suspicion of an overdose, healthcare providers should initiate appropriate emergency protocols. This includes ensuring the patient's airway is secure and providing supplemental oxygen if respiratory distress is noted. Continuous monitoring of vital signs is imperative to assess the patient's stability and response to treatment.

Management Procedures Management of an overdose may involve the administration of specific antidotes, if applicable, and supportive care tailored to the patient's clinical presentation. In cases of severe toxicity, consultation with a poison control center or a medical toxicologist is recommended to guide further management. It is also important to document the incident thoroughly, including the substance involved, the estimated dose, and the time of ingestion, to facilitate appropriate care and follow-up.

Healthcare professionals are advised to remain vigilant and act swiftly in the event of an overdose to mitigate potential complications and ensure optimal patient outcomes.

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 these contexts.

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is available in various package configurations, identified by their respective National Drug Code (NDC) numbers. Specific storage and handling instructions are not provided; therefore, standard practices for pharmaceutical products should be followed. It is recommended to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Additionally, containers should be suitable for pharmaceutical storage, and any special handling requirements should be adhered to as per general guidelines for similar products.

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.