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Acetaminophen

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This product has been discontinued

Active ingredient
Acetaminophen 500 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 2020
Label revision date
July 20, 2020
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
July 20, 2020
Manufacturer
Rescuers Life sciences Limited
NDC root
79583-001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Acetaminophen Tablets 500 mg are a type of medication commonly used to relieve pain and reduce fever. They contain 500 mg of acetaminophen, which works by blocking the production of certain chemicals in the brain that signal pain and fever. This makes acetaminophen a popular choice for treating headaches, muscle aches, arthritis, backaches, toothaches, colds, and fevers.

If you're looking for a way to manage mild to moderate pain or help lower a fever, acetaminophen can be an effective option. It's important to follow the recommended dosage to ensure safe and effective use.

Uses

Acetaminophen is a medication commonly used to help relieve mild to moderate pain, such as headaches, muscle aches, or toothaches. If you're experiencing a fever, acetaminophen can also be effective in reducing your body temperature.

It's important to note that while acetaminophen is widely used and generally considered safe when taken as directed, you should always follow the recommended dosage and consult with a healthcare professional if you have any concerns.

Dosage and Administration

When you need to take acetaminophen, you will be using the 500 mg tablets. This medication is taken orally, which means you will swallow the tablet with water. Make sure to follow the recommended dosage instructions provided by your healthcare provider or the packaging to ensure safe and effective use.

Always remember to take the medication as directed, and if you have any questions about how to use it or how often to take it, don’t hesitate to reach out to your doctor or pharmacist for guidance.

What to Avoid

It's important to be aware of certain precautions when considering medication. While specific contraindications (conditions that make a treatment inadvisable) and details about controlled substances (drugs regulated by law due to their potential for abuse) are not provided here, you should always consult with your healthcare provider about your medical history and any other medications you are taking.

Additionally, be cautious about the potential for abuse or misuse, which refers to using a medication in a way not intended by the prescribing doctor. Dependence (a condition where your body becomes reliant on a substance) can also be a concern with some medications. Always follow your healthcare provider's instructions and do not take or use any medication without their guidance.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, vomiting, abdominal pain, headaches, and dizziness. Allergic reactions can occur, which may involve symptoms like skin rashes, angioedema (swelling under the skin), or even anaphylaxis (a severe allergic reaction).

There are also some serious but rare side effects to be aware of, such as liver damage (hepatotoxicity), elevated liver enzymes, and kidney issues (nephrotoxicity). In very rare cases, you might experience severe skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis. If you notice any unusual symptoms, especially after an overdose, seek medical attention promptly, as this can lead to severe liver damage.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided for this medication. This means that, based on the available information, there are no known risks or necessary precautions to be aware of while using it.

However, if you experience any unusual symptoms or have concerns while taking this medication, it is always a good idea to consult your doctor for guidance. They can provide personalized advice and support based on your health needs.

Overdose

Taking too much acetaminophen can cause serious harm to your liver. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, loss of appetite, confusion, and jaundice (yellowing of the skin or eyes).

If you suspect an overdose, seek immediate medical help or contact a poison control center right away. Acting quickly can make a significant difference in treatment and recovery. Remember, it's always better to be safe and get professional advice 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

While the drug insert for Acetaminophen does not provide specific information about nursing mothers or breastfeeding, it's important to approach any medication use with caution. If you are breastfeeding, you should always consult your healthcare provider before taking any medication, including Acetaminophen. They can help you weigh the benefits and potential risks to ensure the safety of both you and your baby.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage adjustments, or safety concerns outlined for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health by seeking expert advice when it comes to medications.

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 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.

It's always best to consult with your healthcare provider about your individual situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to maintain its integrity and protect it from light exposure, which can affect its quality.

Once you open the container, please remember to discard any remaining contents. This helps ensure safety and effectiveness, as the product may no longer be reliable after opening. By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Acetaminophen Tablets 500 mg used for?

Acetaminophen Tablets 500 mg are used for the relief of mild to moderate pain and for the reduction of fever.

How should I take Acetaminophen Tablets?

You should take Acetaminophen Tablets 500 mg orally.

What are the possible allergic reactions to Acetaminophen?

Possible allergic reactions include anaphylaxis, angioedema, and skin reactions such as rash or urticaria.

What are some gastrointestinal side effects of Acetaminophen?

Gastrointestinal side effects may include nausea, vomiting, and abdominal pain.

What should I know about the risk of overdose with Acetaminophen?

Overdose may lead to severe liver damage, which can be potentially fatal.

How should I store Acetaminophen Tablets?

Store Acetaminophen Tablets at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Are there any specific contraindications for Acetaminophen?

No specific contraindications are mentioned in the provided text.

Is there any information about using Acetaminophen during pregnancy?

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

What are the storage instructions for Acetaminophen Tablets?

Keep Acetaminophen Tablets at room temperature, protect from light, and discard after opening.

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

Acetaminophen Tablets contain 500 mg of acetaminophen as the active ingredient. These tablets are formulated for oral administration and are designed to provide effective pain relief and fever reduction. The appearance of the tablets is typically round and may vary in color depending on the manufacturer.

Uses and Indications

Acetaminophen is indicated for the relief of mild to moderate pain and for the reduction of fever. There are no specific teratogenic or nonteratogenic effects associated with its use as noted in the available data.

Dosage and Administration

Acetaminophen tablets are to be administered orally at a dosage of 500 mg. Healthcare professionals should ensure that the tablets are taken with a sufficient amount of water to facilitate swallowing. It is important to adhere to the recommended dosing intervals and not exceed the maximum daily dosage to avoid potential toxicity.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any unexpected reactions or side effects during treatment.

As there are no recommended laboratory tests or specific monitoring parameters outlined, it is essential for healthcare providers to use clinical judgment and consider individual patient circumstances when determining the need for any laboratory evaluations.

In the event of any adverse reactions or concerns, healthcare professionals should ensure that patients are informed about the importance of seeking immediate medical assistance. Additionally, patients should be advised to communicate with their healthcare provider if they experience any unusual symptoms or if they have any questions regarding their treatment.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include allergic reactions such as anaphylaxis, angioedema, and various skin reactions, including rash and urticaria. Hepatic adverse reactions are also notable, with reports of hepatotoxicity, elevated liver enzymes (e.g., AST, ALT), and, in rare cases, liver failure.

Gastrointestinal disturbances are common, with nausea, vomiting, and abdominal pain reported among participants. Renal adverse reactions, although rare, may include nephrotoxicity. Dermatologic reactions can manifest as skin rash, and there are rare instances of Stevens-Johnson syndrome. Hematologic effects such as thrombocytopenia and leukopenia have been reported infrequently.

Neurological adverse reactions include headache and dizziness, while cardiovascular effects may present as hypotension, which is also rare.

Postmarketing experience has revealed additional serious skin reactions, including toxic epidermal necrolysis, and acute kidney injury, which is considered rare. It is important to note that overdose of this medication may lead to severe liver damage, which can be potentially fatal.

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 dosage adjustments or monitoring recommendations are necessary 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

There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution and consider the lack of pediatric-specific data when prescribing this medication to younger populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

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 to monitor pregnant patients closely if acetaminophen is deemed necessary for use during pregnancy.

Lactation

There is no specific information available regarding the use of Acetaminophen in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information 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 population to ensure safety and efficacy.

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

Overdosage of acetaminophen can result in significant hepatic injury. Healthcare professionals should be vigilant for symptoms indicative of overdose, which may manifest as nausea, vomiting, loss of appetite, confusion, and jaundice.

In the event of an overdose, it is imperative to seek immediate medical attention or contact a poison control center for guidance. Prompt intervention is crucial to mitigate the risk of severe liver damage and to initiate appropriate management strategies.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to use acetaminophen strictly as directed on the package or by a healthcare professional. It is crucial to emphasize that they must not exceed the recommended dose, as doing so may increase the risk of liver damage.

Healthcare providers should inform patients about the signs of liver damage, which may include yellowing of the skin or eyes, dark urine, or severe abdominal pain. Patients with a history of liver disease or those who consume three or more alcoholic beverages per day should be encouraged to consult a healthcare professional before using acetaminophen.

Additionally, patients should be cautioned against taking acetaminophen in conjunction with other products that contain acetaminophen to prevent the risk of accidental overdose. It is important to instruct patients to keep this and all other medications out of the reach of children to ensure safety.

In the event of an overdose, patients should be advised to seek immediate medical attention or contact a Poison Control Center without delay.

Storage and Handling

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

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

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.