Symptom checker
Select audience type

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

ADD CONDITION

items per page

Rapid Comfort Extra Strength Non Aspirin

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
October 14, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
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 2011
Label revision date
October 14, 2011
Manufacturer
Lab Safety Supply, Inc.
Registration number
part343
NDC root
60683-129
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 500 mg is a type of medication known for providing temporary relief from minor aches and pains, such as headaches, muscular aches, toothaches, and menstrual cramps. It is also effective in reducing fever. This extra-strength, non-aspirin medication comes in easy-to-swallow, film-coated tablets, making it a convenient option for those seeking relief from discomfort associated with common conditions like the cold or minor arthritis pain.

You may recognize acetaminophen as a key ingredient in Extra Strength Tylenol®, a well-known over-the-counter pain reliever. It is packaged in tamper-evident unit dose packets for your safety and convenience.

Uses

You can use this medication for the temporary relief of minor aches and pains. This includes discomfort from headaches, muscular aches, minor arthritis pain, toothaches, menstrual cramps, and even aches associated with the common cold. Additionally, it can help reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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 relief. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential health risks.

For children under 12 years old, it is important not to give this adult-strength product, as it contains a dosage that is too high for younger children. Giving them more than the recommended dose can lead to an overdose, which may cause serious liver damage. Always consult with a healthcare professional if you have questions about the appropriate medication for children.

What to Avoid

You should avoid using this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, it's important to consult with your doctor or pharmacist.

Additionally, do not use this medication for more than 10 days to treat pain or more than 3 days for fever unless your doctor has specifically instructed you to do so. Following these guidelines helps ensure your safety and well-being.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 8 tablets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. It's important not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a doctor.

You should consult a doctor before using this product if you have liver disease or are taking the blood-thinning medication warfarin. If your symptoms do not improve, if new symptoms arise, or if pain or fever worsens, stop using the product and seek medical advice. Always keep this medication out of reach of children, and in case of accidental overdose, seek immediate medical help. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if you take more than 8 tablets in 24 hours, use it with other medications that also contain acetaminophen, or consume 3 or more alcoholic drinks daily while using it. To avoid risks, do not use this product with any other acetaminophen-containing drugs, and limit use to no more than 10 days for pain or 3 days for fever unless directed by a doctor.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If your symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens, stop using the product and contact your doctor. Always keep this medication out of reach of children, and in case of accidental overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This 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 wait—get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

It's important to be cautious when giving medication to children. If your child is under 12 years old, you should not give them this adult-strength product, as it can lead to an overdose and potentially cause liver damage.

For children aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, but make sure they do not exceed 8 tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 8 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, avoid using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product, as this can further increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using medications.

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, which can be serious. Always keep your healthcare provider informed about all the medications you are taking to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). It's important to keep the product in its tamper-evident sealed packets, as using any opened or torn packets can compromise safety and effectiveness. Always check the packaging before use to ensure it is intact. By following these simple guidelines, you can help maintain the integrity of the product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is Acetaminophen 500 mg used for?

Acetaminophen 500 mg is used for the temporary relief of minor aches and pains, including headaches, muscular aches, minor arthritis pain, toothaches, menstrual cramps, and for the reduction of fever.

How should adults and children 12 years and older take Acetaminophen 500 mg?

Adults and children 12 years and older should take 2 tablets every 4 to 6 hours as needed, without exceeding 8 tablets in 24 hours.

Can children under 12 years take Acetaminophen 500 mg?

No, do not give this adult strength product to children under 12 years of age, as it may cause an overdose and potential liver damage.

What should I do if I have liver disease?

If you have liver disease, ask a doctor before using Acetaminophen 500 mg.

What are the warnings associated with Acetaminophen 500 mg?

Severe liver damage may occur if you take more than 8 tablets in 24 hours, use it with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if my symptoms do not improve?

Stop using Acetaminophen 500 mg and ask a doctor if your symptoms do not improve, new symptoms occur, or if pain or fever persists or worsens.

How should I store Acetaminophen 500 mg?

Store Acetaminophen 500 mg at room temperature between 59º-86ºF (15º-30ºC) and use tamper-evident sealed packets.

Is it safe to use Acetaminophen 500 mg while pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Acetaminophen 500 mg.

Packaging Info

Below are the non-prescription pack sizes of Rapid Comfort Extra Strength Non Aspirin (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rapid Comfort Extra Strength Non Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Rapid Comfort Extra Strength Non Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen is presented in a dosage form of film-coated tablets, each containing 500 mg of the active ingredient. The product is packaged in a unit dose format, consisting of 100 tablets organized into 50 tamper-evident packets, with 2 tablets per packet. The film coating facilitates ease of swallowing.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 tablets every 4 to 6 hours as needed. The total daily dosage must not exceed 8 tablets within a 24-hour period.

For children under 12 years of age, this adult strength product is contraindicated. Administration to this age group may result in an overdose, which poses a risk of liver damage. Therefore, it is essential to adhere strictly to the recommended age guidelines to ensure safety.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product should not be used for pain relief for more than 10 days unless directed by a physician. It is also contraindicated for the treatment of fever for more than 3 days unless specifically instructed by a healthcare provider.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 tablets within a 24-hour period, combine this product with other medications containing acetaminophen, or consume 3 or more alcoholic beverages daily while using this product.

It is imperative that this product is not used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should be instructed to consult a healthcare provider or pharmacist if they are uncertain about the presence of acetaminophen in their medications. Additionally, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

Patients with a history of liver disease should seek medical advice prior to using this product. Furthermore, individuals taking the anticoagulant warfarin should consult with a healthcare provider or pharmacist before use, as there may be potential interactions.

Patients are advised to discontinue use and consult a healthcare professional if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if there is any redness or swelling.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 8 tablets within a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised not to use this product in combination with any other drug containing acetaminophen, whether prescription or nonprescription. It is also recommended that patients do not use this product for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

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

Patients should discontinue use and consult a healthcare professional if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if redness or swelling is observed.

In the event of accidental overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Pregnant or breastfeeding patients should also consult a healthcare professional before using this product.

This product should be kept out of reach of children to prevent accidental ingestion.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of bleeding complications. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Rapid Comfort Extra Strength Non Aspirin (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rapid Comfort Extra Strength Non Aspirin.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this adult strength product, as it may result in an overdose that could lead to liver damage. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period. Careful adherence to these guidelines is essential to ensure safety and efficacy in this age group.

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. 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt 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, monitoring and evaluation by medical personnel are essential to ensure patient safety and appropriate management of the situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Additionally, healthcare providers should counsel patients who are pregnant or breastfeeding to consult with a health professional before using the medication. This ensures that they receive appropriate guidance regarding the safety and potential risks associated with the use of the medication during these sensitive periods.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 59ºF to 86ºF (15ºC to 30ºC). Proper adherence to these storage conditions is crucial to preserve the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Rapid Comfort Extra Strength Non Aspirin, 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 Rapid Comfort Extra Strength Non Aspirin, 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.