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Acetaminophen Caplets

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
February 15, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
February 15, 2017
Manufacturer
Breeden Brothers, LLC
Registration number
part343
NDC roots
70729-001, 70729-175
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 is an extra strength pain reliever and fever reducer that helps you manage minor aches and pains. It is effective for a variety of discomforts, including headaches, backaches, toothaches, and muscular aches, as well as pain associated with arthritis and menstrual cramps. Additionally, acetaminophen can temporarily reduce fever, making it a versatile option for relief when you're not feeling your best.

This medication comes in caplet form, with each caplet containing 500 mg of acetaminophen. It is marketed under the name "b+b better by giving," emphasizing its role in providing comfort and support during times of discomfort.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, the common cold, backaches, arthritis, toothaches, muscular aches, and menstrual cramps. Additionally, it can 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 your symptoms persist. 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 healthcare provider.

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

You should avoid using this product if you are allergic to acetaminophen or any of its inactive ingredients. Additionally, do not take this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. Following these guidelines is important to ensure your safety and prevent any adverse reactions.

Side Effects

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 containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including rash, blisters, or skin reddening. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should not use this product if you are allergic to acetaminophen or any of its inactive ingredients, or if you are taking other medications that contain acetaminophen. It's important to consult a doctor before using this product if you have liver disease or are taking the blood thinner warfarin. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, stop using the product and contact a doctor, as these could indicate a more serious condition.

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. Be aware that acetaminophen may also cause serious skin reactions, such as rash, blisters, or skin reddening. 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 accidentally take too much, get emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away, even if you don’t notice any symptoms. Additionally, stop using the product and call your doctor if your pain worsens or lasts more than 10 days, your fever worsens or lasts more than 3 days, you develop new symptoms, or if you notice redness or swelling, as these may indicate a serious condition.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. 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 hesitate to 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

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 as needed for symptoms, but be sure not to 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.

In the event of an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable symptoms.

Geriatric Use

If you are an older adult or a caregiver, it's important to be aware of certain precautions when considering medication use. Always consult your doctor before starting any new medication, especially if you have liver disease, as this can affect how your body processes drugs. Additionally, if you are taking the blood thinner warfarin, make sure to discuss this with your doctor or pharmacist to avoid any potential interactions.

In the event of an accidental overdose, seek medical help immediately, even if you do not notice any symptoms. Prompt attention is crucial for both adults and children to ensure safety and proper care.

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 can lead to severe liver damage. This risk increases if you are also taking other medications that contain acetaminophen or if you consume three or more alcoholic drinks each day while using this product.

Before using this product, you should consult with 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. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Taking too much acetaminophen can lead to serious health issues. 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 at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the expiration date on the package and use the product before this date to guarantee its effectiveness.

When handling the product, make sure to maintain a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

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 headaches, the common cold, backaches, toothaches, muscular aches, and menstrual cramps. It also temporarily reduces fever.

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

Adults and children 12 years and over should take 2 caplets every 6 hours while symptoms last, but not more than 6 caplets in 24 hours unless directed by a doctor.

Are there any warnings associated with acetaminophen?

Yes, acetaminophen can cause severe liver damage 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.

What should I do if I experience a skin reaction?

If you experience a rash, blisters, or skin reddening, stop using acetaminophen and seek medical help immediately.

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 in case of an accidental overdose?

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

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 do if my symptoms do not improve?

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.

Who should not use acetaminophen?

Do not use acetaminophen if you are allergic to it or any of its inactive ingredients, or if you are using any other drug containing acetaminophen.

Packaging Info

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

Packaging configurations for Acetaminophen Caplets.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is a non-opioid analgesic and antipyretic agent. Each caplet contains 500 mg of acetaminophen, providing effective pain relief and fever reduction. The product is available in a package containing 50 caplets, designed for convenient dosing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, the common cold, 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 advised 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. Treatment should not extend beyond 10 days without medical supervision.

For children under 12 years of age, it is recommended to consult a healthcare provider for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, concurrent use with any other medication that contains acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

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 alerted to the potential for severe skin reactions associated with acetaminophen use. Symptoms may include rash, blisters, and skin reddening. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

It is essential to consult a healthcare provider prior to use in patients with liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as interactions may occur.

In cases of accidental 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, regardless of the presence of symptoms.

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain or pain lasting more than 10 days, fever worsening or lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as rash, blisters, or skin reddening. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. It is also contraindicated for use with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional before using this product.

Patients are advised to stop use and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Acetaminophen Caplets.
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. Treatment should not exceed 10 days without medical advice.

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

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

In the event of an accidental overdose, prompt medical attention is essential for elderly patients, as well as for children, even if no immediate signs or symptoms are observed. This precaution underscores the importance of careful monitoring and adherence to prescribed dosages in 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 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 be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include rash, blisters, and skin reddening. In cases where a skin reaction occurs, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen Caplets, 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 Caplets, 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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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.