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8 Hour Pain Relief

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Active ingredient
Acetaminophen 650 mg
Other brand names
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 650 mg
Other brand names
Dosage form
Tablet, Extended Release
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 2019
Label revision date
December 11, 2025
Manufacturer
VALU MERCHANDISERS COMPANY
Registration number
ANDA211544
NDC root
63941-401
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Best Choice® is an over-the-counter medication that contains acetaminophen (a common pain reliever and fever reducer) in extended-release tablet form, with each tablet containing 650 mg. It is designed to provide relief for up to 8 hours from minor muscle aches and pains, including those caused by backaches, arthritis, toothaches, menstrual cramps, headaches, and even discomfort associated with the common cold. Additionally, it helps to temporarily reduce fever.

This medication is similar to the active ingredient found in Tylenol® 8HR, making it a familiar option for those seeking effective pain relief and fever reduction. Each package contains 50 capsule-shaped bi-layer tablets, ensuring you have a sufficient supply for your needs.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including muscular aches, backaches, arthritis pain, toothaches, and cramps associated with menstruation. It can also help alleviate headaches and discomfort from the common cold. Additionally, this medication is effective in temporarily reducing fever.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 caplets every 8 hours with a full glass of water. It's important to swallow the caplets whole, so avoid crushing, chewing, splitting, or dissolving them. Make sure 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 old, this medication is not recommended. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen or any of its inactive ingredients. Additionally, do not take this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance.

Be mindful that using this medication improperly can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always follow these guidelines to ensure your safety and well-being.

Side Effects

Taking this medication can lead to some serious side effects, particularly concerning your liver. You should avoid taking more than 6 caplets in a 24-hour period, using it alongside other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while on this product, as these actions can increase the risk of severe liver damage.

Additionally, be aware that acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rashes. If you experience any of these, stop using the medication and seek medical help immediately. It's also important to consult a doctor if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, or if you notice any new symptoms, redness, or swelling, as these could indicate a more serious condition. Always check with a healthcare professional if you have liver disease or are taking blood thinners like warfarin. In case of an overdose, seek medical assistance right away, 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 6 caplets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. 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. You should also stop taking the medication 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 could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. 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, it’s always better to be safe and get checked by a medical professional.

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 12 years old or older, they should not take more than 6 caplets in a 24-hour period unless a doctor advises otherwise. It's important to follow this guideline to ensure their safety and well-being.

For children under 12 years of age, this medication should not be used at all. Always consult with a healthcare professional if you have questions about the appropriate treatment for your child.

Geriatric Use

If you are an older adult or a caregiver, it's important to be cautious when using this medication. Before starting, consult your doctor if you have liver disease, as this can affect how your body processes the medication. Additionally, if you are taking warfarin, a common blood thinner, make sure to talk to your doctor or pharmacist to avoid any potential interactions.

To ensure your safety, do not exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. Also, avoid using this medication for more than 10 days unless directed by your healthcare provider. These guidelines help protect your health and ensure the medication works effectively for you.

Renal Impairment

If you have kidney problems, it's important to know that the provided drug insert does not include 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 or how your kidney function might influence its use.

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 provide guidance based on your individual situation and any other medications you may be using.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not take more than 6 caplets in a 24-hour period, and be careful not to combine it with other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can 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 this medication.

Drug Interactions

It's important to be aware that taking acetaminophen (a common pain reliever) alongside warfarin (a blood thinner) can increase the effects of warfarin, which raises the risk of bleeding. If you are using both medications, your healthcare provider may need to monitor your INR (a blood test that measures how long it takes for your blood to clot) more closely to ensure your safety.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs like acetaminophen. This helps to prevent potential interactions and ensures that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains essential information and warnings that you may need to refer to later.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by swallowing 2 caplets every 8 hours with water. It's important not to crush, chew, split, or dissolve the caplets. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Additionally, make sure to keep it out of reach of children to ensure their safety.

FAQ

What is Best Choice®?

Best Choice® is an acetaminophen-based pain reliever and fever reducer available in extended-release tablets of 650 mg.

What types of pain does Best Choice® relieve?

It temporarily relieves minor aches and pains due to muscular aches, backache, arthritis, toothache, menstrual cramps, headache, and the common cold.

How should adults and children 12 years and over take Best Choice®?

You should take 2 caplets every 8 hours with water, swallowing them whole. Do not exceed 6 caplets in 24 hours unless directed by a doctor.

Are there any contraindications for using Best Choice®?

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

What should I do in case of an overdose?

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

What are the warnings associated with Best Choice®?

Severe liver damage may occur if you exceed 6 caplets in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Can I use Best Choice® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What should I do if my pain or fever worsens?

Stop use 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 8 Hour Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 8 Hour Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for 8 Hour Pain Relief, 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 muscular aches, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, headache, and discomfort related to the common cold. 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 8 hours with water. The caplets should be swallowed whole and must not be crushed, chewed, split, or dissolved. 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 directed by a doctor.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used 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 within the formulation.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period, using it concurrently with other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are instructed to discontinue use and consult a doctor if any of the following occur: worsening pain lasting more than 10 days, fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, use the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can 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.

The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are allergic to acetaminophen or any of the inactive ingredients in this product should also refrain from use.

Patients are advised to stop using the product 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 is observed, as these may indicate a serious condition.

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

In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center immediately (1-800-222-1222). Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of 8 Hour Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 8 Hour Pain Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older should not exceed a maximum dosage of 6 caplets within a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, the use of this medication is not recommended.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment.

Additionally, patients who are taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating therapy with this medication, due to potential interactions that could increase the risk of bleeding.

For all patients, including the elderly, it is important to adhere to the recommended dosage guidelines. The maximum dosage should not exceed 6 caplets within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, the duration of use should not extend beyond 10 days unless advised by a doctor, to mitigate the risk of adverse effects. Regular monitoring and consultation with healthcare providers are recommended to ensure safe use 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 on 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 outlined in the provided drug insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing this medication to patients with reduced kidney function. Regular monitoring of renal function may be prudent in this population, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients consuming three or more alcoholic drinks daily refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

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

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen use. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

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

Storage and Handling

The product is supplied in a carton that contains essential information and warnings, which should be retained for reference. It is recommended to store the product at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 caplets every 8 hours, taken with water. Patients should swallow the caplets whole and are advised against crushing, chewing, splitting, or dissolving them.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 8 Hour Pain Relief, 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 8 Hour Pain Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.