Symptom checker
Select audience type

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

ADD CONDITION

items per page

Notts - Tension Headache

Last content change checked dailysee data sync status

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 2023
Label revision date
November 24, 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 2023
Label revision date
November 24, 2023
Manufacturer
VIVUNT PHARMA LLC
Registration number
M013
NDC root
82706-010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

NOTTS® is a medication designed to provide temporary relief from minor aches and pains, including those caused by common colds, headaches, toothaches, muscular aches, backaches, and menstrual cramps. It is also effective for alleviating minor pain associated with arthritis. Each caplet contains 500 mg of active ingredients, and it is important to note that NOTTS® is aspirin-free, making it a suitable option for those who may be sensitive to aspirin.

This product is specifically formulated to help ease tension headaches and is comparable to other tension headache medications like Excedrin® Tension Headache. With a convenient packaging of 24 caplets, NOTTS® aims to support you in managing everyday discomfort effectively.

Uses

You can use this medication for the temporary relief of minor aches and pains caused by various conditions. This includes discomfort from the common cold, headaches, toothaches, muscular aches, backaches, and cramps related to menstruation or premenstrual syndrome. It can also help alleviate minor pain associated with arthritis.

This medication is designed to provide you with quick relief, allowing you to feel more comfortable during those times when you experience these common types of pain.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not exceed the recommended amount, which means you should not take more than 6 caplets in a 24-hour period unless your doctor advises otherwise.

For adults and children aged 12 years and older, the typical dosage is 2 caplets every 6 hours. If you are considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first to ensure it's safe and appropriate for them. Always remember to use the medication as directed to ensure your safety and well-being.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist for clarification. Additionally, avoid using this medication if you have a known allergy to acetaminophen or any of its inactive ingredients.

By following these guidelines, you can help ensure your safety and avoid potential adverse reactions. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, as this can cause severe liver damage, especially if combined with other acetaminophen-containing products or if you consume three or more alcoholic drinks daily. Be cautious of potential severe skin reactions, which may include symptoms like skin reddening, rash, or blisters. If you experience any of these, stop using the product and seek medical help immediately.

Additionally, this medication contains caffeine, similar to a cup of coffee, so limit other caffeine sources to avoid side effects like nervousness or rapid heartbeat. If you have liver disease or are taking blood thinners like warfarin, consult your doctor before use. If your pain worsens or lasts more than 10 days, or if your fever persists beyond 3 days, stop using the medication and contact a healthcare professional, as these could indicate a serious condition. Always seek immediate medical attention in case of an overdose, even if you don't notice any symptoms.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also lead to serious skin reactions, such as skin reddening, rash, or blisters. If you notice any of these symptoms, stop using the product and seek medical attention immediately.

It's important to limit your intake of caffeine while using this product, as it contains a similar amount of caffeine as a cup of coffee. Too much caffeine can lead to nervousness, irritability, sleeplessness, and rapid heartbeat. If you have liver disease or are taking the blood-thinning medication warfarin, consult your doctor before using this product.

If you suspect an overdose, seek medical help or contact a Poison Control Center right away, even if you don't see any symptoms. Additionally, stop using the product and call your doctor if your pain worsens or lasts more than 10 days, your fever worsens or lasts more than 3 days, you notice redness or swelling, or if new symptoms appear, as these could indicate a serious condition.

Overdose

Taking more than the recommended dosage of medication can lead to an overdose, which is a serious situation. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of overdose.

Signs of an overdose can vary, but it’s essential to act quickly. Remember, prompt medical attention can make a significant difference in the outcome. Always follow the dosage instructions carefully to avoid these risks.

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 adults and children aged 12 years 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 safe and effective use.

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 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

This product contains acetaminophen, which can be harmful to your liver, especially if you have liver problems. It's crucial to avoid taking more than 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit can lead to severe liver damage. Additionally, be cautious about using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

If you have liver disease, it's important to consult with your doctor before using this medication. 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 product, especially if you are taking the blood thinner warfarin, as it can affect how your medications work together. Additionally, be cautious with caffeine—try to limit your intake of caffeine-containing foods, drinks, or medications while using this product, as too much caffeine can lead to feelings of nervousness, irritability, sleeplessness, and even a rapid heartbeat.

You should also avoid using this product alongside any other medications 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 with your healthcare team to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25 °C (68-77 °F). This helps maintain its quality and performance.

When handling the product, be sure to check the packaging carefully. It is tamper-evident, meaning you should not use it if the carton is open or if the foil inner seal is broken or missing. 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 dose is 2 caplets every 6 hours, but do not exceed 6 caplets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Always keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is NOTTS® used for?

NOTTS® is used for the temporary relief of minor aches and pains due to conditions like common cold, headache, toothache, muscular aches, backaches, and menstrual cramps.

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.

Are there any contraindications for NOTTS®?

Do not use NOTTS® with any other drug containing acetaminophen or if you are allergic to acetaminophen or any inactive ingredients.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

Is NOTTS® safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using NOTTS®.

What are the potential side effects of NOTTS®?

Acetaminophen, an ingredient in NOTTS®, may cause severe skin reactions, including skin reddening, rash, and blisters. If you experience these symptoms, stop use and seek medical attention.

What should I limit while taking NOTTS®?

Limit the use of caffeine-containing medications, foods, or beverages while taking NOTTS®, as too much caffeine may cause nervousness and irritability.

What should I do if my pain or fever worsens?

Stop use and ask a doctor if your pain worsens or lasts more than 10 days, or if your fever worsens or lasts more than 3 days.

Packaging Info

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

Packaging configurations for Notts - Tension Headache.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NOTTS® is indicated for the relief of tension headaches. Each caplet contains 500 mg of active ingredients, with a total of 65 mg per caplet. This formulation is aspirin-free and is designed to provide effective headache relief. NOTTS® is comparable to the active ingredients found in Excedrin® Tension Headache. The product is packaged with a National Drug Code (NDC) of 82706-010-01 and is available in a bottle containing 24 caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, toothache, muscular aches, backaches, premenstrual and menstrual cramps, and minor pain from arthritis.

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. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a physician.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed. It is essential to ensure that patients do not exceed the maximum daily limit.

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 the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of its inactive ingredients, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, as this is the maximum daily dosage. Additionally, patients should be cautioned against using this product in conjunction with other medications that contain acetaminophen or consuming three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, rash, or blisters. In the event of any skin reaction, patients must discontinue use immediately and seek medical attention.

Caffeine is another component of this product, with the recommended dosage containing approximately the same amount of caffeine as a standard cup of coffee. Patients should be advised to limit their intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In the case of an overdose, it is imperative that patients do not exceed the recommended dosage. Immediate medical assistance should be sought, or a Poison Control Center contacted, as prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should also recommend that patients consult a physician prior to use if they have a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling is observed, or new symptoms arise. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, which is the maximum daily amount. This risk is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, rash, or blisters. In the event of a skin reaction, it is imperative to discontinue use and seek medical attention immediately.

The recommended dosage of this product contains approximately the same amount of caffeine as a cup of coffee. Therefore, patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while taking this product, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any of the inactive ingredients should refrain from using this product.

Before using this product, patients with liver disease should consult a doctor. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

An overdose warning is also included; patients should not exceed the recommended dosage. 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 initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

Caution is advised regarding the consumption of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is recommended to limit caffeine consumption to mitigate these risks.

This product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. Patients uncertain about the acetaminophen content in their medications should seek guidance from a healthcare professional to avoid the risk of overdose.

Packaging & NDC

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

Packaging configurations for Notts - Tension Headache.
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 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 using this medication. The potential risks and benefits must be carefully weighed, 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 medication 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 absence of guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which can pose significant risks to liver function. It is crucial for patients to consult a healthcare professional prior to using this product if they have a history of liver disease.

Severe liver damage may occur if patients exceed the maximum daily dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of hepatotoxicity. Consumption of three or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate liver damage.

Due to these risks, careful monitoring of liver function is recommended for patients with compromised liver function. Adjustments to dosage or alternative therapies may be necessary based on the severity of hepatic impairment and individual patient circumstances.

Overdosage

In the event of an overdose, it is imperative that individuals do not exceed the recommended dosage. Should an overdose occur, immediate medical assistance should be sought, or the local Poison Control Center should be contacted.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to monitor the patient closely and provide appropriate interventions as necessary.

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 the medication out of the reach of children to prevent accidental ingestion. It is important to inform patients not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using the medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, as these may indicate a serious condition.

Healthcare providers should recommend that patients with liver disease consult a doctor before using this medication. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the packaging prior to use; do not utilize the product if the carton is open or if the foil inner seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25 °C (68-77 °F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 caplets every 6 hours, not to exceed 6 caplets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should obtain medical assistance or contact a Poison Control Center immediately, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Notts - Tension Headache, 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 Notts - Tension Headache, 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.