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Tension Headache Relief

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Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
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 2020
Label revision date
January 31, 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, 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 2020
Label revision date
January 31, 2025
Manufacturer
TARGET CORPORATION
Registration number
M013
NDC root
11673-839
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

373R-Target-Tension Headache Relief IFC 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-related pain, this product may help alleviate your symptoms and provide you with some comfort.

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 concerned about such risks.

Dosage and Administration

When taking this medication, it's important to follow the dosage instructions carefully. For adults and children aged 12 years and older, you should take 2 caplets every 6 hours. However, make sure not to exceed 6 caplets in a 24-hour period. If the person taking the medication is under 12 years old, you should consult a doctor for the appropriate dosage.

You will take the caplets by mouth, which is referred to as oral administration. Remember to stick to the recommended dosage and frequency to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen, as it can cause serious reactions. Additionally, do not take it alongside any other medications that contain acetaminophen, whether they are prescribed or available over-the-counter. If you're uncertain about whether a medication contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance.

Taking these precautions is crucial to prevent potential health risks, including adverse reactions and complications. Always prioritize your safety by being aware of the medications you are using.

Side Effects

You should be aware that acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. Additionally, 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 also contains caffeine, roughly equivalent to a cup of coffee. It's important to limit other sources of caffeine while using it, as too much can lead to nervousness, irritability, sleeplessness, and occasionally a rapid heartbeat. If you notice any new symptoms, or if a painful area becomes red or swollen, or if your pain or fever worsens or lasts longer than the specified time, you should stop using the product and consult a doctor, as these could indicate a serious condition.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. First, if you notice any severe skin reactions such as reddening, blisters, or a rash, stop using it immediately and seek medical help. Additionally, be cautious with the amount you take; exceeding 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. Also, since this product contains caffeine, limit your intake of other caffeine sources to avoid side effects like nervousness or rapid heartbeat.

Before using this product, consult your doctor if you have liver disease or if you are taking the blood thinner warfarin. If you accidentally take too much, seek emergency medical help or contact a Poison Control Center right away, as quick action is crucial. Lastly, stop using the product and call your doctor if you experience any new symptoms, if a painful area becomes red or swollen, if your pain worsens or lasts more than 10 days, or if your fever gets worse or lasts more than 3 days, as these could indicate a serious condition.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, whether the person affected is an adult or a child, even if you don’t see any signs or symptoms of overdose.

Signs of overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

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 breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize professional guidance when it comes to the health of your children.

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 for personalized advice. 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this product. This medication contains acetaminophen, which can be harmful to your liver. To avoid severe liver damage, do not exceed 6 caplets in a 24-hour period. Additionally, be cautious if you are taking other medications that also contain acetaminophen or if you consume 3 or more alcoholic drinks daily while using this product. Always prioritize your liver health and follow your healthcare provider's advice.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, taking acetaminophen (a common pain reliever) alongside other products that also contain acetaminophen can lead to severe liver damage. Additionally, if you're using this product, you should limit your intake of caffeine from medications, foods, or drinks, as too much caffeine can lead to feelings of nervousness, irritability, sleeplessness, and even a rapid heartbeat.

Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being. They can help you navigate potential interactions and make informed choices about your health.

Storage and Handling

It appears that there is no specific storage or handling information available for the product or device you are inquiring about. This means you may not need to worry about particular temperature ranges or special handling instructions. However, it's always a good practice to keep any medical product in a clean, dry place and to follow any general safety guidelines provided by your healthcare provider or the product's packaging.

If you have any concerns or questions about how to use or store the product safely, please consult with your healthcare professional for personalized advice.

Additional Information

No further information is available.

FAQ

What is 373R-Target-Tension Headache Relief IFC used for?

It 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?

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

What should I do if I am allergic to acetaminophen?

Do not use this product if you are allergic to acetaminophen or with any other drug containing acetaminophen.

What are the potential side effects of this product?

Acetaminophen may cause severe skin reactions, liver damage, and nervousness if taken with too much caffeine.

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

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

Can I use this product if I am pregnant or breastfeeding?

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

What should I do in case of an accidental overdose?

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

Is there a caffeine warning associated with this product?

Yes, the recommended dose contains about as much caffeine as a cup of coffee, so limit other caffeine sources to avoid side effects.

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 identified by SPL code 34089-3 is formulated for the relief of tension headaches. It is labeled as 373R-Target-Tension Headache Relief IFC and is packaged in a container holding 100 units, as indicated by the 373R-Target-100ct label.

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

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken orally every 6 hours, with a maximum limit of 6 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to acetaminophen. Additionally, it should not be used concurrently with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 6 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should counsel patients to limit the use of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients with liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In cases of accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

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, with symptoms including skin reddening, blisters, and rash. Patients should discontinue use and seek medical attention if any of these symptoms occur.

There is a significant risk of severe liver damage associated with the use of 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.

Additionally, the product contains caffeine, which is equivalent to the amount found in a 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 nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a healthcare professional if they experience any new symptoms, if a painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever worsens or lasts for more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Severe liver damage may occur if acetaminophen is co-administered with other medications containing acetaminophen. It is advised to avoid the concurrent use of multiple acetaminophen-containing products to mitigate the risk of hepatotoxicity.

Additionally, the use of caffeine-containing medications, foods, or beverages should be limited while taking this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring of caffeine consumption is recommended to prevent these potential side effects.

No specific laboratory test interactions have been identified in 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 patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category.

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 maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects associated with acetaminophen, which is a component of this formulation.

It is critical to adhere to the maximum daily dosage of 6 caplets within a 24-hour period. Exceeding this limit, particularly in conjunction with other medications containing acetaminophen, or consuming 3 or more alcoholic beverages daily while using this product, may lead to severe liver damage. Therefore, careful monitoring of liver function and adherence to recommended dosages is essential for patients with compromised liver function.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely medical evaluation are essential components of managing overdose situations effectively.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using the medication if they have a known allergy to acetaminophen. Additionally, they should not use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

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

It is also important for healthcare providers to remind patients to consult a doctor before using the medication if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions outlined in the provided information. Therefore, healthcare professionals are advised to refer to the product's official labeling or consult with the manufacturer for any additional details regarding storage and handling requirements.

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.

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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.