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Acetaminophen/Caffeine

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Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 16, 2017
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
Capsule
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 2014
Label revision date
November 16, 2017
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-029
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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If you are a consumer or patient please visit this version.

Drug Overview

Health A2Z® is a medication designed to provide temporary relief from tension headaches and minor aches and pains, including muscular aches. It contains two active ingredients: acetaminophen (a common pain reliever) and caffeine (which can enhance the effectiveness of pain relief). Notably, Health A2Z® is aspirin-free, making it a suitable option for those who may need to avoid aspirin.

This product comes in the form of caplets, and it is comparable to other medications that contain similar active ingredients, such as Excedrin® Tension Headache. If you're looking for a way to alleviate tension headaches or minor discomfort, Health A2Z® may be a helpful choice.

Uses

You can use this medication for the temporary relief of minor aches and pains. It is effective for common issues such as headaches and muscular aches.

Rest assured, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your discomfort.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets every 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential side effects.

For children under 12 years old, it’s important to consult a doctor before giving them this medication. They can provide the appropriate guidance on dosage and safety for younger patients. Always follow these instructions carefully to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. It's important to consult with your doctor or pharmacist if you're unsure about the safety of combining it with other medications. This precaution helps prevent potential health risks associated with excessive acetaminophen intake. Always prioritize your safety by checking with a healthcare professional before mixing medications.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Taking more than 8 tablets in 24 hours, using it with other products containing acetaminophen, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. Additionally, aspirin may trigger serious allergic reactions, which can include hives, facial swelling, asthma (wheezing), or shock. Acetaminophen can also cause severe skin reactions, such as skin reddening, blisters, or rash; if you notice any of these symptoms, stop using the product and seek medical help immediately.

This medication contains caffeine, roughly equivalent to a cup of coffee, so it's wise to limit other caffeine sources to avoid side effects like nervousness, irritability, sleeplessness, or a rapid heartbeat. If you experience any new symptoms, notice that your symptoms are worsening, or if pain or fever persists beyond the specified time frames, you should consult your doctor. It's also important to talk to your doctor before using this product if you have liver disease.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 8 tablets in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. Be aware that aspirin may cause serious allergic reactions, including hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen can cause severe skin reactions, such as skin reddening, blisters, or rash. If you experience any skin reaction, stop using the product and seek medical help immediately.

If you have liver disease, consult your doctor before using this product. It's also important to limit caffeine intake from other sources while using this product, as too much caffeine can lead to nervousness, irritability, sleeplessness, and rapid heartbeat. In case of an accidental overdose, seek medical help or contact a Poison Control Center right away, even if you don't notice any symptoms.

You should stop using this product and call your doctor if you develop any new symptoms, if your symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain lasts more than 10 days, or if fever lasts more than 3 days.

Overdose

Taking more than 8 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. It's also important to be cautious if you are using other medications that contain acetaminophen, as combining these can increase the risk of liver damage. Additionally, if you consume three or more alcoholic drinks each day while using this product, you may also be at risk for serious liver issues.

If you suspect an overdose, look for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). In such cases, it is crucial to seek immediate medical help. Always remember to follow the recommended dosage and consult with a healthcare professional if you have any concerns about your medication or alcohol use.

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

When it comes to using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, but you should not exceed 8 tablets in a 24-hour period.

If your child is under 12 years old, it's crucial to consult with a doctor before giving them this medication. This ensures their safety and helps determine the appropriate treatment for their needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 8 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. You should also avoid combining this product with other medications that contain acetaminophen, as this can increase the risk of liver damage.

Additionally, if you consume 3 or more alcoholic drinks daily, you should be especially careful. It's crucial to consult your doctor before using this product if you have liver disease, as they can provide guidance tailored to your specific health needs.

Drug Interactions

It's important to be cautious when taking this medication. You should avoid using it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure about other medications you might be taking, it's best to consult with your doctor or pharmacist.

Additionally, while using this medication, try to limit your intake of caffeine from medications, foods, or drinks. Consuming too much caffeine can lead to feelings of nervousness, irritability, trouble sleeping, and sometimes a rapid heartbeat. Always discuss your current medications and any dietary habits with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and keep the container tightly closed. It's important to protect it from light to maintain its quality. Always keep the product out of reach of children to prevent accidental ingestion. Once opened, be sure to discard the product to avoid any potential risks. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. If you are giving this medication to a child under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What is Health A2Z® used for?

Health A2Z® is used for the temporary relief of minor aches and pains due to headaches and muscular aches.

What are the active ingredients in Health A2Z®?

The active ingredients in Health A2Z® are Acetaminophen and Caffeine. It is also aspirin-free.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 tablets every 6 hours, with a maximum of 8 tablets in 24 hours.

What should children under 12 do before taking Health A2Z®?

Children under 12 years should ask a doctor before using Health A2Z®.

What are the liver warnings associated with Health A2Z®?

Severe liver damage may occur if you take more than 8 tablets in 24 hours, take it with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience a skin reaction while using Health A2Z®?

If you experience a skin reaction such as reddening, blisters, or rash, stop use and seek medical help immediately.

Can I use Health A2Z® with other medications?

Do not use Health A2Z® with any other drug containing acetaminophen without consulting a doctor or pharmacist.

What should I do if my symptoms do not improve?

Stop using Health A2Z® and ask a doctor if any new symptoms occur, if symptoms worsen, or if pain lasts more than 10 days.

Is there a caffeine warning for Health A2Z®?

Yes, the recommended dose contains about as much caffeine as a cup of coffee. Limit other caffeine sources to avoid nervousness, irritability, and sleeplessness.

What precautions should I take if I have liver disease?

You should ask a doctor before using Health A2Z® if you have liver disease.

Packaging Info

Below are the non-prescription pack sizes of Tension Headache Relief. 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

Acetaminophen and Caffeine are combined in this formulation to provide effective relief from tension headaches. This product is aspirin-free, making it suitable for individuals who may be sensitive to aspirin or prefer to avoid it. The dosage form is caplets, designed for convenient administration. The formulation acts as a pain reliever and pain reliever aid, targeting headache discomfort efficiently.

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

Adults and children aged 12 years and over are instructed to take 2 tablets every 6 hours, with a maximum dosage not to exceed 8 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription. Due to the potential for acetaminophen overdose, it is essential to consult a healthcare professional, such as a doctor or pharmacist, before combining this product with any other medications.

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 8 tablets within a 24-hour period. Caution is warranted if the patient is concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Aspirin, another component of this product, may induce severe allergic reactions. Symptoms can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be informed of these potential reactions and advised to seek immediate medical attention if they experience any of these symptoms.

Acetaminophen is also associated with the risk of severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, patients must discontinue use and seek medical assistance promptly.

Caffeine is present in a quantity comparable to that found in a standard cup of coffee. Patients should be cautioned 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.

Healthcare professionals should inquire about the presence of liver disease before recommending this product, as it may exacerbate existing conditions.

In the event of an accidental overdose, immediate medical help should be sought, or the Poison Control Center should be contacted. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a healthcare provider if any new symptoms arise, if existing symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 tablets 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.

Patients should be aware of the potential for severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen has been associated with severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use immediately and seek medical assistance.

The product contains a caffeine dosage comparable to that found in a cup of coffee. Patients should 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 are instructed to stop use and consult a healthcare professional if any new symptoms arise, if symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

Before using this product, patients with liver disease should seek medical advice.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to combining this product with any other drugs to ensure safety and avoid potential overdose.

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, including nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring of caffeine consumption is recommended to mitigate these risks.

Packaging & NDC

Below are the non-prescription pack sizes of Tension Headache Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tension Headache Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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. The maximum recommended dosage is 8 tablets in a 24-hour period; exceeding this limit may lead to significant hepatic injury.

It is advised that patients refrain from taking this product concurrently with other medications that contain acetaminophen to avoid unintentional overdose. Additionally, patients who consume three or more alcoholic drinks daily should avoid using this product, as alcohol can exacerbate the risk of liver damage.

Before initiating treatment, patients with known liver disease should consult their healthcare provider to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Taking more than 8 tablets within a 24-hour period, which constitutes the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to evaluate all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Considerations Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should inquire about alcohol intake during patient assessments and provide appropriate counseling regarding the risks associated with alcohol consumption in conjunction with this medication.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are essential components of management.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is advisable for patients to consult with a doctor or pharmacist before using this medication alongside other drugs if they are uncertain.

Healthcare providers should recommend that patients consult their doctor prior to use if they have a history of liver disease.

Patients must be instructed to discontinue use and consult a doctor if they experience any new symptoms, if existing symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists or worsens beyond 10 days, or if fever worsens or lasts longer than 3 days.

For patients who are pregnant or breastfeeding, it is important to advise them to seek guidance from a health professional before using this medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Additionally, it is essential to keep the product out of reach of children. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

For adults and children aged 12 years and over, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing. No additional information is 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.

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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.