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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 2016
Label revision date
March 31, 2017
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 2016
Label revision date
March 31, 2017
Manufacturer
Chain Drug Consortium, LLC
Registration number
part343
NDC root
68016-657
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

This medication is designed to temporarily relieve minor aches and pains, such as those caused by headaches, muscular aches, backaches, toothaches, and menstrual cramps. It can also help alleviate discomfort associated with arthritis and the common cold. Additionally, this drug is effective in temporarily reducing fever, providing you with relief when you need it most.

Uses

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

Rest assured, there are no 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 should take 2 tablets every 4 to 6 hours as needed while you have symptoms. However, make sure not to exceed 6 tablets in a 24-hour period. It's also important to limit your use to no more than 10 days unless your doctor advises otherwise.

For children under 12 years old, it's best to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage for their age and condition. Always follow these guidelines to use the medication safely and effectively.

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 these precautions can help ensure your safety and well-being.

Side Effects

You should be aware that taking more than 4,000 mg of acetaminophen in a 24-hour period, using other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children.

You should stop using this product and consult a doctor if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, if you develop new symptoms, or if you notice redness or swelling, as these may indicate a serious condition. Additionally, if you have liver disease or are taking the blood-thinning medication warfarin, it’s advisable to speak with a doctor or pharmacist before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in a 24-hour period, take it with other medications that also contain acetaminophen, or consume three or more alcoholic drinks daily while using it. If you have liver disease or are taking the blood-thinning medication warfarin, it’s important to consult your doctor before using this product.

You should stop taking this medication and call your doctor if your pain worsens or lasts more than 10 days, if your fever gets worse or lasts more than 3 days, if you notice any new symptoms, or if you see redness or swelling. These could indicate a more serious health issue that needs 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, acting quickly can make a significant difference in the outcome.

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 you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed for symptoms. However, make sure not to exceed 6 tablets in a 24-hour period, and do not use it for more than 10 days unless directed by a healthcare professional. Always prioritize safety and seek guidance if you have any questions about your child's health.

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, it’s important to consult with a healthcare provider before starting the medication. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. Additionally, you should avoid using this product alongside other medications that also contain acetaminophen, as this can increase your risk of harm.

If you consume three or more alcoholic drinks each day, it's especially crucial to consult with your healthcare provider before using this product, as alcohol can further strain your liver. Always prioritize your liver health by following these guidelines closely.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase your risk of bleeding, so it's crucial to ensure your safety.

Additionally, you should avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for clarification. 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 minor aches and pains does this drug relieve?

This drug temporarily relieves minor aches and pains due to headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, and premenstrual and menstrual cramps.

Does this drug reduce fever?

Yes, this drug temporarily reduces fever.

What should adults and children 12 years and over do for dosage?

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

What should children under 12 years do before taking this drug?

Children under 12 years should ask a doctor before use.

What are the contraindications for this drug?

Do not use this drug with any other drug containing acetaminophen or if you are allergic to acetaminophen or any inactive ingredients in this product.

What are the liver warnings associated with this drug?

Severe liver damage may occur if you take more than 4,000mg of acetaminophen in 24 hours, use it with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks every day while using this product.

What should you do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

When should you stop using this drug and consult a doctor?

Stop using this drug and consult a doctor if pain worsens or lasts more than 10 days, fever worsens or lasts more than 3 days, new symptoms occur, or if redness or swelling is present.

Should you consult a doctor before using this drug if you have liver disease?

Yes, you should ask a doctor before use if you have liver disease.

What should you do if you are pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

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 SPL code for this product is 34089-3. It is presented in a media type of image/jpeg. The reference value associated with this product is 500 mg, and it is available in a dosage form of 100.

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 instructed to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period. Additionally, treatment should not extend beyond 10 days unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor 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. 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.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications that contain acetaminophen or consume three or more alcoholic beverages daily while using this product.

Patients with a history of liver disease should consult a healthcare provider prior to using this product. Furthermore, individuals taking the anticoagulant warfarin are advised to seek guidance from a doctor or pharmacist before use, as potential interactions may occur.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant for signs of severe adverse reactions and advise patients accordingly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe liver damage, which may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

In the event of an overdose, it is critical for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Additionally, patients should consult a doctor prior to use if they have liver disease. It is also recommended that patients taking the blood-thinning medication warfarin seek advice from a healthcare provider or pharmacist before using this product.

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, patients are advised 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 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than three alcoholic drinks per day while using this product. Monitoring of liver function is recommended for patients with existing liver conditions or those who may be at increased risk for hepatic impairment. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of severe liver damage.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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 with a doctor or pharmacist.

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 stop using the medication and seek medical advice if their pain worsens or persists for more than 10 days. Similarly, if a fever worsens or lasts longer than 3 days, patients should discontinue use and consult a healthcare professional.

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. Additionally, patients with liver disease should be advised to consult a doctor before using this medication. Lastly, it is important to recommend that patients taking the blood-thinning medication warfarin 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

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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.