ADD CONDITION

items per page

Acetaminophen

Last content change checked dailysee data sync status

Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
November 27, 2025
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
November 27, 2025
Manufacturer
Elysium Pharmaceuticals Ltd.
Registration number
M013
NDC root
14803-281

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

Acetaminophen is a medication commonly used to relieve pain and reduce fever. It is classified as an anti-inflammatory, which means it helps to decrease inflammation in the body. You might find it helpful for managing mild to moderate pain, such as headaches, muscle aches, or other discomforts.

This medication is widely available and is often found in various over-the-counter products. If you're considering using acetaminophen, it's important to follow the recommended guidelines to ensure its safe and effective use.

Uses

You may use this medication to help reduce inflammation in your body. Inflammation can occur due to various conditions, and this drug works by targeting the underlying processes that cause it.

It's important to note that there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication. This makes it a safer option for those who may be concerned about potential risks during pregnancy. Always consult with your healthcare provider for personalized advice and information regarding your specific health needs.

Dosage and Administration

When using this medication, it serves as an anti-inflammatory, which means it helps reduce swelling and pain. You will need to follow specific instructions for how to take or apply it, depending on your individual needs.

Make sure to prepare the medication as directed, and use it consistently to achieve the best results. If you have any questions about how to use it or how often to take it, don’t hesitate to ask your healthcare provider for guidance.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. This means that, based on the information provided, there are no particular instructions advising against taking or using this medication. Always remember to follow your healthcare provider's guidance and reach out to them if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential adverse reactions when using this medication. While specific side effects were not detailed, you should always monitor for any unusual symptoms and consult your healthcare provider if you have concerns.

Additionally, this medication should be kept out of reach of children to prevent accidental ingestion. Always prioritize safety and follow your healthcare provider's guidance regarding any concerns you may have.

Warnings and Precautions

It’s important to keep this medication out of reach of children to prevent accidental ingestion. Always store it in its original packaging to ensure safety and avoid any mix-ups.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor immediately. If you have any concerns or questions about your treatment, don’t hesitate to reach out to your healthcare provider for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and seek help if you have any concerns.

Pregnancy Use

Currently, there is no specific information available about the use of Acetaminophen during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking any medication, including Acetaminophen, to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may need during this time.

Lactation Use

Currently, there is no specific information available about the use of Acetaminophen while breastfeeding. This means that the effects of this medication on nursing mothers and their infants have not been clearly studied or documented.

If you are breastfeeding and considering taking Acetaminophen, it’s a good idea to consult with your healthcare provider. They can help you weigh the benefits and any potential risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

You can feel reassured that there are no specific concerns or special precautions for older adults when using Acetaminophen. The information available does not indicate any need for dosage adjustments or safety issues specifically related to elderly patients. This means that if you or a loved one is considering Acetaminophen for pain relief or fever reduction, it can generally be used without additional worries about age-related factors. Always remember to follow the recommended dosage instructions and consult with a healthcare provider if you have any questions or concerns.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

It’s important to keep this product out of reach of children to ensure their safety. For proper storage, make sure to keep it at room temperature, avoiding extreme heat or cold. This will help maintain the product's effectiveness and safety for use. Always handle it with care to prevent any damage or contamination.

Additional Information

No further information is available.

FAQ

What is Acetaminophen?

Acetaminophen is an anti-inflammatory medication used to relieve pain and reduce fever.

What are the indications for using Acetaminophen?

Acetaminophen is indicated for its anti-inflammatory properties.

Are there any teratogenic effects associated with Acetaminophen?

No teratogenic effects are mentioned for Acetaminophen.

What should I know about dosage and administration of Acetaminophen?

Acetaminophen is used as an anti-inflammatory, and specific dosage instructions should be followed as per packaging.

Are there any contraindications for Acetaminophen?

There are no contraindications listed for Acetaminophen.

What precautions should I take when using Acetaminophen?

Keep Acetaminophen out of reach of children and store it at room temperature.

Is there any information regarding the use of Acetaminophen during pregnancy?

There is no specific information regarding the use of Acetaminophen during pregnancy.

Can nursing mothers use Acetaminophen?

The provided text does not include specific information regarding the use of Acetaminophen by nursing mothers.

What should I do if I have kidney or liver problems and want to use Acetaminophen?

The text does not provide specific information regarding the use of Acetaminophen for patients with kidney or liver problems.

Packaging Info

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

Packaging configurations for Acetaminophen.
Details

Drug Information (PDF)

This file contains official product information for Acetaminophen, 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 drug.

Uses and Indications

This drug is indicated for the treatment of inflammatory conditions. It possesses anti-inflammatory properties that may be beneficial in managing various inflammatory disorders.

There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for the anti-inflammatory agent is determined based on the specific clinical condition being treated. Healthcare professionals should assess the patient's individual needs and adjust the dosage accordingly.

For initial administration, the typical dosage range is established to ensure effective anti-inflammatory action while minimizing potential side effects. It is crucial to monitor the patient's response to therapy and make necessary adjustments to the dosage as required.

Administration should be performed using appropriate techniques to ensure optimal absorption and efficacy. The route of administration may vary depending on the formulation and the specific requirements of the treatment plan.

Healthcare professionals are advised to follow established guidelines for frequency of administration, ensuring that doses are spaced adequately to maintain therapeutic levels while preventing toxicity. Regular follow-up assessments are recommended to evaluate the effectiveness of the treatment and to make any necessary modifications to the dosage regimen.

In cases where further packing is indicated, the healthcare provider should ensure that the preparation is handled according to standard protocols to maintain the integrity of the medication.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should advise patients and caregivers on the importance of proper storage and handling of the medication, ensuring that it is secured in a location inaccessible to children.

Additionally, it is recommended to retain the original packaging for future reference, which may contain important information regarding the medication's use, storage conditions, and expiration date. This practice not only aids in maintaining the integrity of the medication but also serves as a reminder of the necessary precautions associated with its use.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, which could lead to serious adverse reactions.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the noted warning. It is essential for healthcare providers to monitor patients for any unexpected effects and to report such occurrences to ensure comprehensive safety data is maintained.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen.
Details

Pediatric Use

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

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions associated with the use of Acetaminophen as indicated in the provided drug insert. Therefore, standard dosing guidelines may be applied without modification for this population. However, healthcare providers should continue to monitor elderly patients for any potential adverse effects, as individual responses to medication can vary.

Pregnancy

There is no specific information available regarding the use of Acetaminophen during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients and weigh the potential benefits against any unknown risks. It is advisable for women of childbearing potential to discuss their individual circumstances with their healthcare provider before using Acetaminophen during pregnancy.

Lactation

There is no specific information regarding the use of Acetaminophen in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when considering the administration of this medication to lactating mothers, as the potential excretion of Acetaminophen in breast milk and its effects on breastfed infants have not been established.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is critical. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

It is imperative that healthcare professionals document all findings and interventions meticulously and monitor the patient closely for any evolving symptoms or complications.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of 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. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

This product is supplied in packaging that ensures safety and integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion. The recommended storage condition is at room temperature, ensuring that the product maintains its efficacy and safety. No special handling requirements are noted; however, standard precautions should be observed to preserve the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, 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, 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.