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Cvs Acetaminophen

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
September 4, 2025
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
Marketed in the U.S.
Since 2018
Label revision date
September 4, 2025
Manufacturer
Sixarp, LLC
Registration number
M013
NDC root
59368-231

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Drug Overview

Acetaminophen is a pain reliever and fever reducer commonly used to help alleviate minor aches and pains. This includes discomfort from conditions such as the common cold, headaches, backaches, toothaches, muscular aches, and menstrual cramps. It is also effective in temporarily reducing fever.

Typically available in 500 mg caplets, acetaminophen is intended for adult use and can be compared to the active ingredient found in Extra Strength Tylenol. If you're looking for relief from everyday pain or 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 the common cold, headaches, backaches, arthritis, toothaches, muscular aches, and menstrual cramps. It can also help reduce fever for a short period.

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to feel better and carry on with your daily activities.

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, it's important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. Additionally, you should not use this medication for more than 10 days unless directed by your doctor.

For children under 12 years of age, 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 use it alongside any other drugs that contain acetaminophen (a common pain reliever found in many over-the-counter and prescription medications). 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 ever experienced an allergic reaction to it or any of its ingredients. Your safety is a priority, so make sure to follow these guidelines closely.

Side Effects

Taking this product may lead to some serious side effects. It contains acetaminophen, which can cause severe liver damage if you exceed 4,000 mg in a day, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen can trigger severe skin reactions, such as skin reddening, blisters, or rashes. If you notice any of these symptoms, stop using the product and seek medical help immediately.

You should also avoid using this product if you have had an allergic reaction to it or any of its ingredients, or if you are taking blood thinners like warfarin. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, contact your doctor. In case of an overdose, seek medical assistance right away, even if you don’t see any symptoms, as prompt treatment is crucial.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin reactions, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you suspect an overdose, it’s crucial to get emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if you don’t notice any symptoms. You should also stop using the product and call your doctor if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, if new symptoms develop, or if you notice any redness or swelling, as these could indicate a serious condition.

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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, as well as adults, you should not use the medication for more than 10 days unless your doctor specifically advises you to do so. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

Geriatric Use

If you are an older adult or caring for one, it's important to consult a doctor before using this medication, especially if there is a history of liver disease (a condition where the liver does not function properly). Additionally, if you or the person you are caring for is 12 years or older, be aware that this medication should not be used for more than 10 days unless a doctor specifically advises otherwise. This helps ensure safety and effectiveness while minimizing potential risks.

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 you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please consult the guidelines provided with your product.

Additional Information

You should take this medication orally, using 2 caplets every 6 hours as needed for symptoms. However, do not exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. If you are an adult or a child aged 12 years and older, do not use this medication for more than 10 days unless directed by a healthcare professional. If the patient is under 12 years old, consult a doctor before use.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer used to temporarily relieve minor aches and pains due to conditions like the common cold, headache, backache, toothache, and menstrual cramps.

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.

Can children under 12 years use Acetaminophen?

If you are considering giving Acetaminophen to a child under 12 years, you should ask a doctor first.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop using Acetaminophen and seek medical help immediately.

What are the liver warnings associated with Acetaminophen?

Severe liver damage may occur if you take more than 4,000 mg 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 in case of an overdose?

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

Is it safe to use Acetaminophen if I am pregnant or breastfeeding?

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

What should I do if my pain or fever worsens?

You should 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.

Packaging Info

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

Packaging configurations for Cvs Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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 while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive 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.

Additionally, this product should not be used in individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

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 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as there may be potential interactions.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should also be instructed to stop taking the product and consult a healthcare professional if they experience any of the following: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or any signs 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 taking this product containing acetaminophen if they exceed 4,000 mg in a 24-hour period, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using the product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Additionally, individuals with liver disease should consult a doctor prior to use. Those taking the blood-thinning medication warfarin are advised to seek guidance from a healthcare professional before using this product.

Patients are instructed to stop use and consult a doctor 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 redness or swelling occurs, as these may indicate a serious condition.

In cases of overdose, it is crucial 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Cvs 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 medication should not be used for more than 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease. It is important for geriatric patients to be aware that the medication should not be used for more than 10 days unless specifically directed by a physician. This precaution is particularly relevant for patients aged 65 and older, as they may have an increased risk of adverse effects and may require closer monitoring during treatment.

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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

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 medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to refrain from using the product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be advised to consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 caplets every 6 hours as needed for symptom relief. Patients should not exceed 6 caplets within a 24-hour period unless directed by a healthcare professional. For adults and children aged 12 years and older, the use should not extend beyond 10 days unless advised by a physician. For children under 12 years, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cvs 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 Cvs 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.

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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.