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Tension Headache Pain Relieving Aid

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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 15, 2023
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 2024
Label revision date
December 15, 2023
Manufacturer
WAL-MART STORES INC
Registration number
M013
NDC root
79903-373
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

This medication is designed to temporarily relieve minor aches and pains, including those caused by headaches and muscular aches. It works by targeting the discomfort you may feel, helping to provide some relief when you need it most. If you're experiencing these types of pain, this medication can be a supportive option to consider.

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

When taking this medication, it's important to follow the directions carefully. 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 best to consult a doctor before giving them this medication.

Remember, you should only use the amount directed and take the caplets orally (by mouth). This will help ensure you use the medication safely and effectively.

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 prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, it's important to consult with your doctor or pharmacist for clarification. Taking these precautions will help ensure your safety and well-being.

Side Effects

You should be aware that acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these reactions, 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.

It's also important to note that the recommended dose contains about as much caffeine as a cup of coffee. Too much caffeine can lead to nervousness, irritability, sleeplessness, and sometimes a rapid heartbeat, so consider limiting other sources of caffeine while using this product. If you have liver disease or are taking blood thinners like warfarin, consult your doctor before use. Stop using the product and seek medical advice if you notice any new symptoms, if a painful area becomes red or swollen, or if pain or fever worsens or lasts longer than expected.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. First, if you experience any severe skin reactions such as reddening, blisters, or a rash, stop using the product immediately and seek medical help. Additionally, be cautious with the amount you take, as exceeding 6 caplets in 24 hours, using other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. If you are sensitive to caffeine, note that this product contains a similar amount of caffeine as a cup of coffee, so 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 are taking the blood thinner warfarin. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately, as prompt attention is crucial. You should also stop using the product and call your doctor if you notice any new symptoms, if a painful area 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, as these could indicate a serious condition.

Overdose

If you suspect an 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 for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an 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 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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 caplets every 6 hours, but be sure not to exceed 6 caplets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver disease, it's important to consult your doctor before using this product. It contains acetaminophen, which can be harmful to your liver. Taking more than 6 caplets in a 24-hour period, using other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage. Always prioritize your liver health and follow your healthcare provider's advice regarding medication use.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, you should avoid using this medication with any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Always prioritize open communication about your medications to help prevent any harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F) occasionally, but try to keep it as close to the recommended temperature as possible. Always check the expiration date on the package and use the product before that date to ensure its safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains due to headache 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 am allergic to acetaminophen?

Do not use this product if you are allergic to acetaminophen, and consult a doctor if you have any concerns.

Are there any warnings associated with this drug?

Yes, it may cause severe skin reactions and liver damage if taken in excess or with other acetaminophen-containing drugs.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop use and seek medical help immediately.

Can I take this drug 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 overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Is there a caffeine warning 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.

What should I do if my symptoms worsen or new symptoms occur?

Stop use and consult a doctor if any new symptoms occur, or if pain or fever worsens or lasts longer than specified durations.

Packaging Info

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

Packaging configurations for Tension Headache Pain Relieving Aid.
Details

Drug Information (PDF)

This file contains official product information for Tension Headache Pain Relieving Aid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

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 the age of 12, it is advised to consult a physician for appropriate dosing recommendations.

Oral administration is the preferred route, and patients should ensure that the caplets are taken as directed, without exceeding the specified dosage.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, 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 three 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 advise patients 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 liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help 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 medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe skin reactions have been reported, particularly in individuals with an allergy to acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Liver-related adverse effects are a significant concern, as this product contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, 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 prior to use.

Caffeine content in the recommended dose of this product is comparable to that found in 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 nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should refrain from using this product if they have a known allergy to acetaminophen. It is also advisable for patients to consult a doctor before use if they are currently taking the blood-thinning medication warfarin or if they have liver disease.

Patients are instructed to stop use and seek medical advice if any new symptoms arise, if a painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Tension Headache Pain Relieving Aid.
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

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human 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 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 lack of data 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 note that severe liver damage may occur if patients exceed the recommended dosage of 6 caplets within a 24-hour period. Additionally, the risk of liver injury is heightened when this product is taken concurrently with other medications containing acetaminophen or when patients consume 3 or more alcoholic beverages daily while using this product.

Due to these considerations, careful monitoring of liver function and adherence to recommended dosing guidelines is essential for patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential 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 health consequences. Therefore, vigilance and timely action are crucial in 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.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods. Encouraging open communication about their health status will help ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Tension Headache Pain Relieving Aid, 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 Pain Relieving Aid, 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.