Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Acetaminophen

Last content change checked dailysee data sync status

This product has been discontinued

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 2016
Label revision date
March 31, 2017
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 2016
Label revision date
March 31, 2017
Manufacturer
Chain Drug Consortium, LLC
Registration number
part343
NDC root
68016-655
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

Acetaminophen is a medication commonly used to temporarily relieve minor aches and pains, such as headaches, muscular aches, backaches, toothaches, and menstrual cramps. It is also effective in reducing fever. This makes it a popular choice for managing discomfort associated with conditions like the common cold and arthritis.

With a dosage of 325 mg, acetaminophen has been a trusted option for pain relief and fever reduction since its effectiveness was established on January 25, 2017. If you're looking for a way to alleviate mild pain or lower a fever, acetaminophen may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, backaches, toothaches, and minor arthritis pain. It can also help with discomfort from the common cold and menstrual cramps. Additionally, this medication is effective in temporarily reducing fever.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed for your symptoms. However, make sure not to exceed 10 tablets in a 24-hour period, and avoid using the medication for more than 10 days unless your doctor advises otherwise.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. It's important to limit their intake to no more than 5 tablets in a 24-hour period and not to use the medication for more than 5 days unless directed by a healthcare professional.

If your child is under 6 years old, please consult a doctor before giving them this medication.

What to Avoid

It's important to be cautious when using this medication. You should not take it if you are allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, avoid using it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist for guidance.

Taking this medication inappropriately can lead to serious issues, including dependence (a condition where your body becomes reliant on a substance) and potential misuse. Always follow the instructions provided and consult a healthcare professional if you have any questions or concerns.

Side Effects

You should be aware of some important warnings and potential side effects associated with this medication. If you experience worsening pain that lasts more than 10 days in adults or more than 5 days in children under 12, or if a fever worsens or lasts more than 3 days, it’s essential to stop using the medication and consult a doctor. Additionally, if you notice new symptoms or see redness or swelling, these could indicate a serious condition that requires medical attention.

Before using this medication, it's advisable to speak with your doctor if you have liver disease or if you are taking the blood-thinning medication warfarin, as these factors may affect your treatment. Always prioritize your health and safety by staying informed about how this medication may impact you.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have liver disease, as this could affect how the medication works for you.

You should stop taking the medication and contact your doctor if you experience any of the following: if your pain worsens or lasts more than 10 days in adults or more than 5 days in children under 12, if your fever worsens or lasts more than 3 days, if you notice new symptoms, or if you see redness or swelling. These could indicate a more serious condition that needs medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

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

If your child is under 6 years old, it's important to consult a doctor before using this medication. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, but they should not take more than 5 tablets in a 24-hour period or use it for more than 5 days unless directed by a doctor.

For children 12 years and older, they can take 2 tablets every 4 to 6 hours, with a maximum of 10 tablets in 24 hours and a limit of 10 days of use unless advised otherwise by a healthcare professional. Be alert for any worsening pain lasting more than 5 days, fever that persists or worsens after 3 days, new symptoms, or any redness or swelling, as these may indicate a more serious health issue that requires medical attention.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. To ensure your safety and the effectiveness of your treatment, your renal function should be monitored regularly.

Before starting any therapy, it's recommended that you undergo renal function tests. These tests should also be repeated periodically to keep track of your kidney health throughout your treatment. Regular monitoring helps your healthcare provider make any necessary changes to your medication plan.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your doctor might change how much of the drug you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, as they will guide you on the best approach to manage your treatment safely.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood thinner that helps prevent blood clots. Mixing these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, you should avoid using this medication alongside any other products that contain acetaminophen, which is a common pain reliever found in many over-the-counter and prescription drugs. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Always prioritize open communication about your medications to help prevent any harmful interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the neck wrap or foil inner seal is intact. If any of these seals are broken or missing, do not use the product, as this could compromise its safety. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to temporarily relieve minor aches and pains from headaches, muscular aches, backaches, arthritis, the common cold, toothaches, and menstrual cramps, as well as to reduce fever.

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

Adults and children 12 years and over should take 2 tablets every 4 to 6 hours while symptoms last, not exceeding 10 tablets in 24 hours or 10 days unless directed by a doctor.

What is the dosage for children aged 6-11 years?

Children aged 6-11 years should take 1 tablet every 4 to 6 hours while symptoms last, not exceeding 5 tablets in 24 hours or 5 days unless directed by a doctor.

What should I do if I have liver disease?

If you have liver disease, ask a doctor before using Acetaminophen, as dosage adjustments may be necessary.

Can I use Acetaminophen with other medications?

Do not use Acetaminophen with any other drug containing acetaminophen. If unsure, consult a doctor or pharmacist.

What should I do if my symptoms worsen?

Stop use and ask a doctor if pain lasts more than 10 days in adults, more than 5 days in children under 12, or if fever lasts more than 3 days.

Is Acetaminophen safe during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Acetaminophen.

How should I store Acetaminophen?

Store Acetaminophen between 20-25°C (68-77°F) and do not use if the carton is opened or the seal is broken.

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

The product contains 325 mg of the active ingredient. It is formulated as a solid dosage form, suitable for oral administration. The appearance of the dosage form is consistent with standard specifications for this type of medication.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period. Additionally, treatment should not extend beyond 10 days unless specifically directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake must not exceed 5 tablets, and treatment duration should not exceed 5 days unless instructed by a physician.

For children under 6 years of age, it is recommended to consult a healthcare provider for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Healthcare professionals should exercise caution when prescribing this medication, particularly in patients with pre-existing conditions. It is imperative to consult a physician prior to use in individuals with liver disease, as this may influence the safety and efficacy of the treatment.

Monitoring for adverse effects is essential. Patients should be advised to discontinue use and seek medical attention if any of the following occur:

  • Pain that worsens or persists beyond 10 days in adults.

  • Pain that worsens or lasts more than 5 days in children under 12 years.

  • Fever that worsens or lasts more than 3 days.

  • The emergence of new symptoms.

  • The presence of redness or swelling.

These signs may indicate a serious underlying condition that requires immediate medical evaluation. Regular assessment and patient education on these parameters are crucial for ensuring safe use of the medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to note that serious adverse reactions may occur, and patients should be vigilant for specific symptoms.

In the event of an overdose, patients should seek immediate medical attention. Additionally, patients are advised to stop use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days in adults, pain worsens or lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is present. These symptoms could indicate a serious underlying condition that requires medical evaluation.

Patients with liver disease should consult a doctor prior to using this medication. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use to avoid potential interactions.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

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 under 6 years of age should consult a healthcare professional before use. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. This age group should not exceed 5 days of use unless directed by a physician.

In adolescents aged 12 years and older, the dosage increases to 2 tablets every 4 to 6 hours while symptoms persist, with a maximum of 10 tablets in a 24-hour period. Similar to younger children, this age group should not use the medication for more than 10 days unless advised by a healthcare provider.

Healthcare professionals should be aware of warning signs in pediatric patients, including worsening pain lasting more than 5 days in those under 12 years, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious condition requiring further evaluation.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels. Additionally, it is recommended to perform renal function tests prior to initiating therapy and periodically thereafter in patients with renal impairment to ensure safe and effective treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with liver dysfunction, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is essential to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years. Additionally, if a patient experiences a fever that worsens or lasts more than 3 days, they should stop using the medication and consult a doctor.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. Furthermore, it is important to advise patients to consult a doctor before using this medication if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a secure carton, and it is essential to store it at a temperature range of 20-25°C (68-77°F). Healthcare professionals should ensure that the carton remains unopened and that the neck wrap or foil inner seal is intact and unbroken. If the carton is opened or if the neck wrap or foil inner seal is broken or missing, the product should not be used.

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.