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Cvs Acetaminophen

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
October 2, 2025
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
Marketed in the U.S.
Since 2025
Label revision date
October 2, 2025
Manufacturer
CVS Pharmacy
Registration number
M013
NDC root
51316-185

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, toothaches, and muscular aches. It can also help alleviate minor pain associated with arthritis and menstrual cramps. Additionally, this drug is effective in temporarily reducing fever, providing comfort when you're feeling unwell.

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 muscular aches, as well as premenstrual and menstrual cramps. Additionally, this medication can help reduce fever temporarily, providing you with some comfort when you're not feeling well.

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 of this medication to no more than 10 days unless directed by a healthcare professional.

For children under 12 years of age, it's essential 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

You should avoid using this medication if you are allergic to acetaminophen or any of its inactive ingredients. Additionally, it is important not to take this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you are unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist for guidance. Taking acetaminophen in combination with other acetaminophen-containing drugs can lead to serious health risks.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including symptoms like skin reddening, blisters, or rash.

You should stop using this product and consult a 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 new symptoms, or if you see redness or swelling, as these could indicate a serious condition. If you have liver disease or are taking the blood thinner warfarin, it's important to talk to your doctor or pharmacist before using this product. In case of an overdose, seek medical help immediately, even if you don't notice any symptoms.

Warnings and Precautions

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

Before using this medication, 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. Additionally, stop taking the medication and call your doctor if your pain worsens or lasts more than 10 days, your fever gets worse or lasts more than 3 days, you develop new symptoms, 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 medical attention 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 it’s always better to be safe and 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 your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours as needed for symptoms, but be sure not to exceed 6 caplets in a 24-hour period unless a doctor advises otherwise.

Additionally, it's crucial to avoid using this medication for more than 10 days unless directed by a healthcare professional. Always prioritize your child's safety and well-being by following these guidelines closely.

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

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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Acetaminophen can interact with warfarin, which may affect how well your blood is thinned.

Always keep your healthcare provider informed about all the medications you are taking to ensure your safety and the effectiveness of your treatments.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What does this drug temporarily relieve?

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

Does this drug reduce fever?

Yes, this drug temporarily reduces fever.

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

Take 2 caplets every 6 hours while symptoms last, and do not take more than 6 caplets in 24 hours unless directed by a doctor.

What should I do if I am under 12 years old?

If you are under 12 years old, ask a doctor before use.

Are there any 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 should I do if I experience severe skin reactions?

If you experience severe skin reactions such as skin reddening, blisters, or rash, stop use and seek medical help right away.

What should I do in case of overdose?

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

What precautions should I take if I have liver disease?

Ask a doctor before use if you have liver disease, as this product contains acetaminophen which can cause severe liver damage.

Can I use this drug if I am taking warfarin?

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin, as acetaminophen may interact with it.

What should I do if my pain or fever worsens?

Stop use and call your doctor if pain gets worse or lasts more than 10 days, or if fever gets worse or 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 older 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:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

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.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must 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 interactions that require monitoring.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Patients should also be advised to discontinue use and contact their healthcare provider 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 the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash.

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 redness or swelling occurs, as these may indicate a serious condition.

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

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. Co-administration of these agents should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are currently taking warfarin. Monitoring of INR (International Normalized Ratio) levels may be warranted to ensure therapeutic efficacy and safety, as acetaminophen can potentially alter the anticoagulant effect of warfarin.

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 recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period unless otherwise directed by a physician. It is important to note that the medication should not be used for more than 10 days without medical supervision.

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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

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

Renal Impairment

Patients with renal impairment 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may 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, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate 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 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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid response in overdose situations.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and symptomatic treatment.

In summary, the critical nature of overdose situations necessitates immediate action and adherence to medical guidelines to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, 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.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that quick medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

No further data are available.

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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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.