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Acetaminophen/Aspirin/Caffeine

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Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 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 2024
Label revision date
January 28, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 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 2024
Label revision date
January 28, 2026
Manufacturer
Elysium Pharmaceutical Ltd
Registration number
M013
NDC root
14803-135
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

You may be interested to know that this medication is classified as an analgesic (a type of drug that helps relieve pain) and an antipyretic (a medication that helps reduce fever). It is commonly used to alleviate discomfort and lower elevated body temperatures. While specific details about how it works are not provided, its primary purpose is to help you feel better when you're experiencing pain or fever.

Uses

You can use this medication as an analgesic (pain reliever) and antipyretic (fever reducer). It helps alleviate discomfort and lower elevated body temperatures.

Additionally, there are no teratogenic effects (harmful effects on fetal development) or nonteratogenic effects (harmful effects that do not involve fetal development) associated with this medication, making it a safer option for use in various situations.

Dosage and Administration

When it comes to using this medication, it is important to understand that it is specifically intended for manufacturing, processing, or repacking. This means that it is not meant for direct use by patients but rather for healthcare facilities or pharmaceutical companies that prepare medications for distribution.

If you are involved in the handling of this medication, ensure that you follow all guidelines for safe processing and repacking. Always consult with a healthcare professional or pharmacist if you have questions about how this medication should be used in a clinical setting.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or warnings regarding its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may be relieved to know that there are no serious, common, or rare side effects reported for this medication. Additionally, there are no known allergic reactions or issues related to the cardiovascular, neurological, or dermatologic systems. Overall, the safety profile appears to be very favorable, with no adverse reactions documented in postmarketing experiences.

Warnings and Precautions

It’s important to keep this medication out of the reach of children to ensure their safety. Before using the product, make sure to remove the silica gel bag, as it is not safe for consumption.

If you experience any unusual symptoms or reactions, stop using the medication immediately and contact your doctor for guidance. Always prioritize your health and safety by following these precautions closely.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

It’s important to be cautious about the medications you take during pregnancy. The safety of using acetaminophen, aspirin, and caffeine while pregnant has not been clearly established. Specifically, aspirin is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby.

If you are pregnant or planning to become pregnant, it’s essential to talk to your healthcare provider before using any of these medications. They can help you understand the potential risks to your fetus and guide you on safe options for managing any discomfort you may experience.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

It's important to keep this medication out of the reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store medications in a safe place, such as a locked cabinet, to ensure your child's safety. If you have any concerns about how to manage medications in your home, don't hesitate to ask your healthcare provider for guidance.

Geriatric Use

As you age, your body may respond differently to medications, including acetaminophen, aspirin, and caffeine. Older adults often have increased sensitivity to the side effects of these drugs, which means you might experience more pronounced effects than younger individuals. It's important to be aware that dosage adjustments may be necessary, especially if you have reduced kidney function, a common concern in older adults.

When taking this medication, special precautions should be considered based on your overall health and any other medications you may be using. Always consult with your healthcare provider to ensure that your treatment plan is safe and effective for your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

It's important to keep this product out of the reach of children to ensure their safety. Before using the product, make sure to remove the silica gel bag, which is included to absorb moisture and keep the product dry.

For optimal storage, follow any specific temperature guidelines provided with the product, and handle it carefully to maintain its integrity. Always dispose of any packaging materials, like the silica gel bag, responsibly after use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the primary use of this medication?

This medication is used as an analgesic (pain reliever) and antipyretic (fever reducer).

Are there any teratogenic effects associated with this medication?

No teratogenic effects have been mentioned for this medication.

Is this medication contraindicated during pregnancy?

Yes, aspirin is contraindicated during pregnancy, especially in the third trimester, due to the risk of fetal harm.

What precautions should pregnant women take when considering this medication?

Pregnant women should consult a healthcare provider before using this medication due to potential risks to the fetus.

Are there any specific instructions for elderly patients?

Yes, elderly patients may have increased sensitivity to side effects, and dosage adjustments may be necessary due to potential reduced kidney function.

What should you do if you have children around this medication?

Keep this medication out of the reach of children and remove the silica gel bag before use.

Are there any known adverse reactions to this medication?

No serious, common, or rare adverse reactions have been listed for this medication.

What is the route of administration for this medication?

The medication is administered orally.

Packaging Info

Below are the non-prescription pack sizes of Acetaminophen Aspirin and Caffeine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen Aspirin and Caffeine.
Details

Drug Information (PDF)

This file contains official product information for Acetaminophen Aspirin and Caffeine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of pain (analgesic) and the reduction of fever (antipyretic).

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For manufacturing, processing, or repacking, the dosage and administration should be conducted in accordance with established protocols and guidelines specific to the product being utilized. It is essential that healthcare professionals adhere to the recommended practices to ensure safety and efficacy.

The preparation of the product must be performed in a controlled environment, following aseptic techniques to prevent contamination. The specific dosage range and frequency of administration will depend on the formulation and intended use of the product.

Healthcare professionals are advised to consult the relevant product monograph or prescribing information for detailed instructions regarding the appropriate dosing intervals and any necessary adjustments based on patient-specific factors.

All procedures should comply with local regulations and institutional policies to ensure optimal outcomes in patient care.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. Additionally, prior to use, it is essential to remove the silica gel bag included with the product, as it is not intended for consumption and poses a choking hazard.

Healthcare professionals are advised to ensure that patients are informed about these safety measures to promote safe handling and usage of the product. Regular reminders about the importance of child safety and proper disposal of non-consumable components should be communicated to patients and caregivers.

Side Effects

There are no serious, common, less common, or rare adverse reactions associated with the use of this product. Additionally, no allergic reactions, cardiovascular, neurological, or dermatologic adverse reactions have been reported. The postmarketing experience has not indicated any adverse reactions. Overall, the safety profile of this product appears to be favorable, with no significant adverse reactions documented in clinical trials or postmarketing observations.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Aspirin and Caffeine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen Aspirin and Caffeine.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of the reach of children. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse by pediatric populations.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of acetaminophen, aspirin, and caffeine. This heightened sensitivity necessitates careful monitoring and consideration of potential adverse effects when prescribing these agents.

Dosage adjustments may be required for geriatric patients, particularly due to the potential for reduced kidney function, which is more common in this population. It is essential for healthcare providers to assess renal function and adjust dosages accordingly to avoid toxicity and ensure therapeutic efficacy.

Special precautions should be taken when administering this medication to elderly patients. Consideration of their overall health status, including comorbidities and concurrent medications, is crucial to minimize the risk of adverse reactions and drug interactions. Regular monitoring and reassessment of treatment plans are recommended to ensure the safety and well-being of geriatric patients.

Pregnancy

The use of acetaminophen, aspirin, and caffeine during pregnancy has not been established as safe. Aspirin is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. There is a potential risk to the fetus when using this medication during pregnancy. Therefore, pregnant women should consult a healthcare provider before using this medication to discuss potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: gastrointestinal bleeding, liver damage, and allergic reactions. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to keep the product out of the reach of children to ensure safety.

For optimal storage and handling, the product should be kept in a controlled environment. It is important to remove the silica gel bag before use to prevent any potential contamination or adverse effects. Proper adherence to these guidelines will help maintain the integrity and safety of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Acetaminophen Aspirin and Caffeine, 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 Acetaminophen Aspirin and Caffeine, 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.