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Acetaminophen

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This product has been discontinued

Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Capsule
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
July 17, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Capsule
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
July 17, 2017
Manufacturer
FREDS, INC
Registration number
part343
NDC root
55315-989
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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, USP is an extra strength pain reliever available in capsule-shaped tablets, each containing 500 mg of the active ingredient. It is commonly used to temporarily relieve minor aches and pains associated with various conditions, including the common cold, headaches, backaches, toothaches, muscular aches, and menstrual cramps. Additionally, acetaminophen can help reduce fever.

This medication works by blocking the production of certain chemicals in the brain that signal pain and fever, providing you with relief when you need it most. Whether you're dealing with everyday discomfort or a mild fever, acetaminophen can be a helpful option to consider.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, and toothaches. It is also effective for easing minor arthritis pain, muscular aches, and cramps associated with menstruation or premenstrual syndrome.

In addition to pain relief, this medication can help lower fever temporarily, making it a useful option when you're feeling unwell. Always consult with a healthcare professional if you have any questions about its use or if your symptoms persist.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 caplets every 6 hours as long as you have symptoms. However, make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. It's also important to limit your use to no more than 10 days unless directed by a healthcare professional.

For children under 12 years old, it's best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs 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. Additionally, avoid using this product if you have a known allergy to acetaminophen or any of its inactive ingredients.

By following these guidelines, you can help ensure your safety while using this medication. Always prioritize your health and seek professional advice if you have any questions or concerns.

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, consult a doctor before use if you have liver disease or are taking the blood-thinning medication warfarin.

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. It's important to consult your doctor before using this product if you have liver disease or are taking the blood thinner warfarin.

If you experience worsening pain that lasts more than 10 days, a fever that persists for more than 3 days, new symptoms, or any redness or swelling, stop using the product and contact your doctor. 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.

Remember, signs of an overdose can vary, and it’s always better to be safe. If you have any concerns, don’t hesitate to reach out for help. Your health and safety are the top priority.

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 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours while symptoms persist, but you should not exceed 6 caplets in a 24-hour period unless directed by a doctor. Additionally, do not use this medication for more than 10 days without a doctor's guidance.

Be aware that in case of an overdose, seeking quick medical attention is crucial for both adults and children, even if there are no immediate signs or symptoms. Always prioritize safety and follow these guidelines closely.

Geriatric Use

When considering this medication, it's important to consult your doctor, especially if you or an older adult you care for has liver disease, as this condition can be more common in elderly patients who may have other health issues. While there are no specific dosage adjustments or safety concerns noted for older adults, it's always best to discuss any potential risks with a healthcare professional.

In case of an overdose, seek medical help immediately, even if there are no noticeable symptoms. Quick action is crucial for everyone, including older adults, to ensure their safety and well-being.

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 medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

Hepatic Impairment

Taking this product, which contains acetaminophen, requires special attention if you have liver problems. It's important to avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, as doing so can lead to severe liver damage. Additionally, be cautious about using other medications that also contain acetaminophen, as this can increase your risk of harm.

If you consume three or more alcoholic drinks daily, you should avoid this product altogether, as combining alcohol with acetaminophen can significantly worsen liver health. Always consult your healthcare provider for personalized advice and to ensure safe use of this medication.

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 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 best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This range is known as USP Controlled Room Temperature, which helps maintain the product's effectiveness. Always check the end panel for the lot number and expiration date to ensure you are using a valid product.

When handling the product, be sure to do so with clean hands and in a safe environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to temporarily relieve minor aches and pains due to conditions like the common cold, headache, backache, toothache, and menstrual cramps, as well as to reduce fever.

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

You should take 2 caplets every 6 hours while symptoms last, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

What should I do if I experience an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using it.

Can I use Acetaminophen if I have liver disease?

You should ask a doctor before using Acetaminophen if you have liver disease.

What should I do if my pain or fever worsens?

Stop using Acetaminophen and consult a doctor if your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days.

Is Acetaminophen safe to use during pregnancy or breastfeeding?

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

What should I avoid while taking Acetaminophen?

Do not use Acetaminophen with any other drug containing acetaminophen, and avoid it if you are allergic to acetaminophen or any inactive ingredients in the product.

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, USP, is an extra strength pain reliever and fever reducer, available in capsule-shaped tablets. Each tablet contains 500 mg of acetaminophen. The product is packaged in a bottle containing 100 caplets, providing a total of 100 doses.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, 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 caplets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional 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

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that liver damage may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is crucial to exercise caution when recommending this product to patients with pre-existing liver disease. Patients should be instructed to consult a healthcare provider prior to use if they have liver disease. Additionally, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as potential interactions may occur.

Patients should be informed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain or pain lasting more than 10 days, fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who 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 imperative for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial 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 beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Individuals with liver disease should consult a doctor prior to use. Additionally, patients taking the blood-thinning medication warfarin are encouraged to seek advice from a doctor 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 toxicity. 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 caplets every 6 hours as needed, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a healthcare provider. Treatment should not exceed 10 days without medical advice.

In cases of overdose, prompt medical attention is essential for both pediatric and adult patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the prescribing information. However, it is important for healthcare providers to exercise caution when prescribing this medication to geriatric patients, particularly those with comorbidities such as liver disease. It is advisable for elderly patients to consult with their healthcare provider before initiating treatment if they have a history of liver disease.

In the event of an overdose, prompt medical attention is crucial for all adults, including elderly patients, even if they do not exhibit any immediate signs or symptoms. Monitoring and timely intervention are essential to ensure the safety and well-being of geriatric patients receiving this medication.

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 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

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. Due to the potential for severe liver damage, it is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients must avoid the concurrent use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Furthermore, patients with compromised liver function should refrain from consuming three or more alcoholic drinks daily while using this product, as alcohol can exacerbate the hepatotoxic effects of acetaminophen. Regular monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and to mitigate the risk of severe adverse effects.

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

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients contained 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, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25°C (68-77°F), in compliance with USP Controlled Room Temperature guidelines. It is essential to refer to the end panel of the packaging for the lot number and expiration date to ensure proper tracking and usage.

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.