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Acetaminophen 325 mg

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Active ingredient
Acetaminophen 325 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 2017
Label revision date
January 27, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 325 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 2017
Label revision date
January 27, 2023
Manufacturer
Granules India Limited
NDC root
62207-178
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Acetaminophen Tablets 325 mg are a type of medication commonly used to relieve pain and reduce fever. This over-the-counter drug is often recommended for various conditions, including headaches, muscle aches, arthritis, backaches, toothaches, colds, and fevers.

By working in the brain, acetaminophen helps to block the production of certain chemicals that cause pain and fever, making you feel more comfortable when you're unwell. It's important to use this medication as directed to ensure its effectiveness and safety.

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 helping to lower your body temperature.

It's important to note that there are no specific teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects mentioned for acetaminophen, making it a widely used option for pain and fever relief. Always consult with a healthcare professional if you have any questions about its use.

Dosage and Administration

When you need to take acetaminophen, you will be taking it by mouth. The standard dose is 325 mg, which means you should take one tablet or the equivalent amount as directed. It's important to follow the instructions on the packaging or those given by your healthcare provider to ensure you are taking the correct amount.

Make sure to take acetaminophen as needed, but be mindful of the recommended frequency to avoid taking too much. Always check the label for specific guidance on how often you can take it, and if you have any questions, don’t hesitate to ask your doctor or pharmacist for clarification.

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 your doctor, and the risk of dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and never take or use medication without their guidance. If you have any concerns or questions, don't hesitate to reach out to your healthcare professional for clarification.

Side Effects

Taking this medication can lead to some side effects, and it's important to be aware of them. Common reactions include nausea, vomiting, stomach pain, loss of appetite, and headaches. You should also be cautious, as taking more than the recommended dose can cause severe liver damage.

In less common cases, you might experience allergic reactions such as skin rash, itching, or swelling, as well as liver enzyme abnormalities. Rarely, severe allergic reactions (anaphylaxis) and serious skin conditions like Stevens-Johnson syndrome or toxic epidermal necrolysis can occur. If you have liver disease or consume alcohol heavily, use this medication with caution, as an overdose can lead to fatal liver failure.

Warnings and Precautions

It seems that the specific warnings, precautions, and instructions for emergency help or stopping use of the medication were not provided in the text. Therefore, I cannot offer detailed information on these important aspects.

If you have any specific concerns or questions about a medication, it's best to consult your healthcare provider or pharmacist. They can provide you with the necessary information tailored to your situation. Always prioritize your health and safety by seeking professional advice when needed.

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, vomiting, loss of appetite, confusion, and jaundice (a yellowing of the skin and eyes).

If you suspect an overdose, seek immediate medical attention. Treatment may involve giving activated charcoal to help absorb the drug and N-acetylcysteine as an antidote to protect your liver. Remember, acting quickly can make a significant difference in recovery.

Pregnancy Use

There is no specific information available about the use of Acetaminophen 325 mg 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 your healthcare provider before taking this medication 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

If you are breastfeeding, it's important to know that acetaminophen can be passed into your breast milk. This means that when you take acetaminophen, your baby may be exposed to it through your milk. While using acetaminophen, you should consider the potential risks to your infant. Always consult with your healthcare provider to discuss the safest options for pain relief while nursing.

Pediatric Use

When it comes to using this medication in children, there is currently no specific information available regarding its safety or effectiveness for pediatric patients (children). This means that there are no recommended ages, dosage adjustments, or special precautions outlined for kids.

As a parent or caregiver, it's important to consult with a healthcare professional before giving this medication to a child, as they can provide guidance based on the child's individual health needs. Always prioritize safety and seek expert advice when it comes to medications for children.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

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 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 change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains effective for your needs.

Additional Information

No further information is available.

FAQ

What is Acetaminophen used for?

Acetaminophen is used for the relief of mild to moderate pain and for the reduction of fever.

How should I take Acetaminophen 325 mg?

You should administer Acetaminophen 325 mg orally as directed.

What are the common side effects of Acetaminophen?

Common side effects include nausea, vomiting, stomach pain, loss of appetite, and headache.

What should I be cautious about when taking Acetaminophen?

Use Acetaminophen with caution if you have liver disease or consume heavy alcohol, as overdose can lead to fatal liver failure.

Are there any severe reactions associated with Acetaminophen?

Yes, severe allergic reactions such as anaphylaxis and skin reactions like Stevens-Johnson syndrome can occur, though they are rare.

Can I take Acetaminophen while nursing?

Nursing mothers should be aware that acetaminophen can be excreted in breast milk, and there is a consideration of infant risk.

What are the storage instructions for Acetaminophen?

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

Packaging Info

Below are the non-prescription pack sizes of Acetaminophen 325 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen 325 mg.
Details

Drug Information (PDF)

This file contains official product information for Acetaminophen 325 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen Tablets contain 325 mg of acetaminophen as the active ingredient. These tablets are formulated for oral administration and are designed to provide effective analgesic and antipyretic effects. The product is characterized by its standard dosage form, which facilitates ease of use in clinical settings.

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.

Dosage and Administration

Acetaminophen 325 mg is to be administered orally. Healthcare professionals should ensure that the dosage is taken as directed, adhering to the recommended dosing guidelines. It is important to monitor the patient for any adverse effects and to adjust the dosage as necessary based on individual patient needs and response to treatment.

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

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific monitoring parameters should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, vigilance in monitoring and patient education regarding the signs of potential complications are crucial for the safe administration of this medication.

Side Effects

Severe liver damage may occur if patients exceed the recommended dose. Therefore, it is crucial to adhere to dosing guidelines to mitigate the risk of overdose, which can lead to fatal liver failure.

Common adverse reactions reported by participants in clinical trials include nausea, vomiting, stomach pain, loss of appetite, and headache. These reactions were observed with varying frequencies and may impact patient compliance.

Less common adverse reactions include allergic reactions such as skin rash, itching, or swelling, as well as liver enzyme abnormalities. These events should be monitored, particularly in patients with pre-existing liver conditions.

Rare adverse reactions have also been documented, including severe allergic reactions like anaphylaxis and serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Patients with liver disease or those who consume alcohol heavily should use this medication with caution, as they may be at increased risk for adverse effects.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 325 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen 325 mg.
Details

Pediatric Use

Pediatric use information is not provided in the insert. There are no recommended ages, dosing differences, safety concerns, or special precautions for children mentioned. As such, healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the lack of specific data.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of Acetaminophen 325 mg during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medication use with their healthcare provider during pregnancy.

Lactation

Lactating mothers should be aware of the potential for excretion of acetaminophen in breast milk. There is a consideration of infant risk when acetaminophen is used by nursing mothers.

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 may necessitate individualized assessment and monitoring based on the patient's overall clinical status and renal function.

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 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 considered as part of standard clinical practice.

Overdosage

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

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate potential liver damage.

Management of acetaminophen overdosage typically involves the administration of activated charcoal to limit further absorption of the drug, along with N-acetylcysteine, which serves as an antidote to replenish glutathione stores and facilitate the detoxification of acetaminophen metabolites. Timely treatment is essential for optimal patient outcomes.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to use acetaminophen only as directed on the package or by a healthcare professional. It is crucial that patients do not exceed the recommended dose of acetaminophen, 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.

Patients should also be instructed to keep acetaminophen out of reach of children and to seek immediate medical attention in the event of an accidental overdose. Additionally, it is important for patients to be aware that acetaminophen may interact with other medications. They should be encouraged to inform their healthcare provider of all medications they are currently taking to avoid potential interactions.

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 a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°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 325 mg, 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 325 mg, 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.