Symptom checker
Select audience type

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

ADD CONDITION

items per page

Tension Headache Relief

Last content change checked dailysee data sync status

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 2018
Label revision date
December 7, 2023
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 2018
Label revision date
December 7, 2023
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Registration number
M013
NDC root
68210-0190
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

VALUMEDS™ is a pain reliever that contains two active ingredients: acetaminophen (a common medication used to relieve pain and reduce fever) and caffeine (a stimulant that can enhance the effectiveness of pain relief). This medication is designed to temporarily relieve minor aches and pains, including headaches and muscular aches.

If you're looking for a solution to alleviate discomfort from these types of pain, VALUMEDS™ may be a suitable option for you. It is comparable to the active ingredients found in EXCEDRIN® TENSION HEADACHE, making it a reliable choice for managing tension-related headaches and other minor aches.

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

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 2 caplets every 6 hours, but make sure not to exceed 6 caplets in a 24-hour period. This means you can take the medication multiple times throughout the day, but always stick to the recommended amount.

If you are considering this medication for a child under 12 years old, it's best to consult with a doctor first. They can provide guidance on the appropriate dosage for younger patients. Remember, never use more than the directed amount to avoid any potential risks.

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 unsure whether a medication contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance. Taking these precautions will help ensure your safety and well-being.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed the maximum daily limit of 6 caplets, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Additionally, the recommended dose contains caffeine, similar to a cup of coffee, so it's wise to limit other caffeine sources to avoid side effects like nervousness, irritability, sleeplessness, or rapid heartbeat. If you notice any new symptoms, or if pain or fever worsens or lasts beyond the specified time frames, consult a doctor, as these could indicate a serious condition. Always check with a healthcare professional if you have liver disease or are taking blood thinners like warfarin before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 caplets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rash. If you experience any skin issues, stop using the product and seek medical help immediately. Additionally, the recommended dose has about the same amount of caffeine as a cup of coffee, so it's wise to limit other caffeine sources to avoid nervousness, irritability, 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 assistance or contact a Poison Control Center right away 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 develop 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 overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1(800)222-1222. 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, acting quickly can make a significant difference in the outcome.

Pregnancy Use

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

Lactation Use

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

Pediatric Use

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

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 6 caplets in a 24-hour period can lead to severe liver damage. This risk increases if you are also using other medications that contain acetaminophen or if you consume 3 or more alcoholic drinks each day while using this product.

Before using this product, you should consult with your doctor, especially if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don't hesitate to seek professional advice.

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 your 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 and safety of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). After each use, make sure to close the cap tightly to maintain its integrity. It's also important to read all the product information carefully before using it, and keep the box for future reference, as it contains essential details you may need later. 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 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period. If the patient is under 12 years old, it’s important to consult a doctor for appropriate dosing guidance.

FAQ

What is VALUMEDS™ used for?

VALUMEDS™ is used to temporarily relieve minor aches and pains due to headaches and muscular aches.

What are the active ingredients in VALUMEDS™?

The active ingredients in VALUMEDS™ are acetaminophen and caffeine.

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 VALUMEDS™ if you are allergic to acetaminophen or if you are taking any other drug containing acetaminophen.

What are the liver warnings associated with VALUMEDS™?

Severe liver damage may occur if you take more than 6 caplets in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience a skin reaction?

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

Can I use VALUMEDS™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using VALUMEDS™.

What should I do in case of an overdose?

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

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

Stop use and ask a doctor if any new symptoms occur, if the painful area is red or swollen, or if pain lasts more than 10 days.

How should I store VALUMEDS™?

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

Packaging Info

Below are the non-prescription pack sizes of Tension Headache Relief (acetaminophen and 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

VALUMEDS™ is a formulation designed for the relief of tension headaches, containing active ingredients comparable to those found in EXCEDRIN® TENSION HEADACHE*. Each caplet includes acetaminophen and caffeine, serving as a pain reliever and pain reliever aid. The product is supplied in a package containing 24 caplets. VALUMEDS™ is distributed by Spirit Pharmaceuticals LLC, located in Ronkonkoma, NY 11779.

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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing guidance. It is imperative that patients do not exceed the directed dosage to ensure safety and efficacy.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 caplets within a 24-hour period. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should be counseled to limit the intake of other caffeine-containing medications, foods, and beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

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

In the event of an overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The Poison Control Center can be reached at 1(800)222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if any new symptoms arise, if a painful area becomes red or swollen, if pain worsens or persists beyond 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 several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets 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.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Caffeine is also a component of this product, with the recommended dose containing approximately the same amount of caffeine as a standard cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, and beverages while using this product, as excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are instructed to stop use and consult a doctor 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.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 Relief (acetaminophen and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tension Headache Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period.

Geriatric Use

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects related to hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to contact the Poison Control Center at 1(800)222-1222 for guidance on managing the situation effectively.

The potential symptoms of an overdose may vary depending on the substance involved, and healthcare providers should remain vigilant for any clinical manifestations that may arise. Early recognition and management of these symptoms are essential to mitigate risks and ensure patient safety.

In summary, the key actions to take in the case of an overdose include obtaining medical help promptly and utilizing the resources available through the Poison Control Center. This proactive approach is vital in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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 overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent. The Poison Control Center can be reached at 1(800)222-1222.

Patients should be informed not to use the medication if they have a known allergy to acetaminophen. Additionally, they should be cautioned against using 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 consult with a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and seek medical advice if any new symptoms arise. They should also be advised to stop using the medication and consult a doctor if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should also seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and safety.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for important information regarding the product.

Additional Clinical Information

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

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.