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Clear Choice Regular Strength Pain Reliever

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Active ingredient
Acetaminophen 325 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 2013
Label revision date
December 11, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 325 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 2013
Label revision date
December 11, 2018
Manufacturer
Athlete's Needs, Inc.
Registration number
M013
NDC root
53185-005
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

Acetaminophen is a clear choice for relieving minor aches and pains, as well as reducing fever. It is commonly used to help with discomfort associated with conditions like the common cold, headaches, toothaches, muscular aches, backaches, minor arthritis pain, and menstrual cramps. This medication is caffeine-free and does not contain aspirin, making it a suitable option for many people seeking pain relief.

Each tablet contains 325 mg of acetaminophen, and it is available in a bottle of 100 tablets. If you have any questions about this product, you can reach out to the manufacturer for more information.

Uses

You can use this medication for the temporary relief of minor aches and pains that may arise from various conditions. This includes discomfort associated with the common cold, headaches, toothaches, muscular aches, backaches, and minor arthritis pain. Additionally, it can help alleviate premenstrual and menstrual cramps, as well as temporarily reduce fever.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

Dosage and Administration

If you or your child are in need of this medication, here’s how to take it safely. For adults and children aged 12 years and older, you should take 2 tablets every 4 to 6 hours as needed, but make sure not to exceed 10 tablets in a 24-hour period.

For children between the ages of 6 and 11, the dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. It’s important to note that this medication is not suitable for children under 6 years of age, as using it could lead to an overdose, which can cause serious health issues. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when using this medication. You should never take it alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. This is crucial to avoid potential harm.

Additionally, make sure to follow the recommended dosage carefully. Exceeding the suggested amount can lead to serious health issues. Always prioritize your safety by adhering to these guidelines.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take more than 5 doses in a day if you are a child, use it alongside other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including skin reddening, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should stop using this product and consult a doctor if your symptoms do not improve, if your pain worsens or lasts longer than 10 days (or 5 days for children under 12), if your fever worsens or lasts more than 3 days, or if you notice new symptoms, redness, or swelling. It's also important to talk to a doctor before using this product if you have liver disease or are taking the blood-thinning medication warfarin.

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 or if a child takes more than 5 doses in the same time frame. Be cautious if you consume three or more alcoholic drinks daily while using this product, as this increases the risk of liver issues. Additionally, acetaminophen may cause serious skin reactions, such as redness, blisters, or rashes. If you notice any skin reactions, stop using the product and seek medical help immediately.

You should stop using this product and consult your doctor if your symptoms do not improve, if your pain worsens or lasts longer than 10 days (or 5 days for children under 12), if your fever worsens or lasts more than 3 days, or if you experience new symptoms, redness, or swelling. In case of an accidental overdose, it is crucial to get emergency medical help right away by contacting a doctor or the Poison Control Center at 1-800-222-1222, even if you do not see any immediate signs or symptoms.

Overdose

Taking too much acetaminophen can lead to serious liver damage. For adults, this risk increases if you take more than 4,000 mg in a 24-hour period. For children, giving more than 5 doses in the same timeframe can also be harmful. Additionally, combining acetaminophen with other medications that contain it can heighten the risk of liver damage. If you regularly consume 3 or more alcoholic drinks each day, using acetaminophen can further increase this risk.

If you suspect an overdose, look for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). It’s crucial to seek immediate medical help if you notice any of these symptoms or if you believe you have taken too much acetaminophen. Always consult a healthcare professional if you have concerns about your dosage or potential interactions with other medications.

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 aged 6 to 11 years, they can take 1 tablet every 4 to 6 hours as needed, but make sure they do not exceed 5 tablets in a 24-hour period. For children under 6 years old, it’s important not to use this regular strength product, as it could lead to an overdose and serious health issues.

If your child is under 12 and their pain worsens or lasts more than 5 days, you should stop using the medication and consult a doctor. Always prioritize your child's safety and follow these guidelines closely.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

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.

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. For children, giving more than 5 doses in a day can also be harmful. Additionally, combining this product with other medications that contain acetaminophen increases the risk of liver damage.

If you consume three or more alcoholic drinks daily, you should avoid using this product, as it can further strain your liver. Always consult with your healthcare provider for personalized advice and to ensure safe use of medications.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, 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 multiple medications with acetaminophen can lead to serious health issues, including liver damage. Always consult with your healthcare provider about all the medications you are taking to prevent harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). It's important to keep it in a safe place where it won't be exposed to extreme temperatures.

Before using the product, check that the safety seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its quality.

Additional Information

No further information is available.

FAQ

What is Acetaminophen used for?

Acetaminophen is used for the temporary relief of minor aches and pains associated with conditions like the common cold, headache, toothache, muscular aches, backache, minor arthritis pain, and menstrual cramps. It also temporarily reduces fever.

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

Adults and children 12 years and older should take 2 tablets every 4 to 6 hours as needed, without exceeding 10 tablets in 24 hours.

What is the recommended dosage for children aged 6 to 11 years?

Children aged 6 to 11 years should take 1 tablet every 4 to 6 hours as needed, not exceeding 5 tablets in 24 hours.

Can children under 6 years of age use this product?

No, children under 6 years of age should not use this regular strength product as it may lead to an overdose and serious health problems.

What should I do if I experience a skin reaction?

If you experience 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 an adult takes more than 4,000 mg in 24 hours, a child takes more than 5 doses in 24 hours, or if it is taken with other drugs containing acetaminophen. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at risk.

What should I do in case of an accidental overdose?

In case of an accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for both adults and children.

Is it safe to use Acetaminophen while pregnant 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?

You should stop using Acetaminophen and consult a doctor if your symptoms do not improve, if pain lasts more than 10 days, or if fever lasts more than 3 days.

Can I take Acetaminophen with other medications?

You should not use Acetaminophen with any other drug containing acetaminophen, whether prescription or nonprescription. Consult a doctor or pharmacist if you are taking blood thinners like warfarin.

Packaging Info

Below are the non-prescription pack sizes of Clear Choice Regular Strength Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Clear Choice Regular Strength Pain Reliever.
Details

Drug Information (PDF)

This file contains official product information for Clear Choice Regular Strength Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Clear Choice Regular Strength is a pain reliever formulated with acetaminophen, providing effective relief from pain and fever. Each tablet contains 325 mg of acetaminophen and is free from aspirin and caffeine. The product is available in a bottle containing 100 tablets. It is manufactured for A.N.I., located at 6029 Renaissance Place, Toledo, OH 43623.

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, toothache, muscular aches, backache, minor pain of arthritis, 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 12 years of age and older are instructed to take 2 tablets every 4 to 6 hours as needed. The total daily dosage must not exceed 10 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum limit of 5 tablets in a 24-hour period.

This product is not recommended for use in children under 6 years of age, as it may lead to an overdose and result in serious health complications.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. Additionally, exceeding the recommended dosage is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning

  • Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period.

  • Children should not take more than 5 doses in a 24-hour period.

  • Caution is advised when this product is used concurrently with other medications containing acetaminophen.

  • Adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Monitoring and Consultation Healthcare professionals should advise patients to stop using the product and consult a physician if any of the following occur:

  • Symptoms do not improve.

  • Pain worsens or persists for more than 10 days.

  • In children under 12, pain worsens or lasts more than 5 days.

  • Fever worsens or lasts more than 3 days.

  • New symptoms develop.

  • Redness or swelling is observed.

  • A rare sensitivity reaction is suspected.

Emergency Medical Help In cases of accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a healthcare provider or the Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent. Prompt intervention is essential for both adults and children.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, and children should not take more than 5 doses within the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients are instructed to stop using the product and consult a healthcare professional if symptoms do not improve, if pain worsens or persists for more than 10 days, or if pain lasts more than 5 days in children under 12. Additionally, if fever worsens or lasts for more than 3 days, if new symptoms arise, if redness or swelling is observed, or if a rare sensitivity reaction occurs, medical advice should be sought.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist prior to use.

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. Monitoring for signs of liver damage is advised if acetaminophen is used concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Clear Choice Regular Strength Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Clear Choice Regular Strength Pain Reliever.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. For children under 6 years of age, the regular strength product is not recommended due to the risk of overdose, which could lead to serious health problems.

Healthcare professionals should advise caregivers to discontinue use and consult a doctor if a child's pain worsens or persists for more than 5 days in patients under 12 years of age.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

  • An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period.

  • A child takes more than 5 doses of the product in a 24-hour period.

  • The product is taken concurrently with other medications that contain acetaminophen.

  • An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function adhere strictly to the dosing guidelines and avoid exceeding the recommended daily limits. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen beyond the recommended limits.

Adult Overdosage An adult who ingests more than 4,000 mg of acetaminophen within a 24-hour period is at risk of experiencing severe liver damage. It is crucial for healthcare professionals to monitor patients for symptoms of liver toxicity, which may include nausea, vomiting, loss of appetite, confusion, and jaundice. Immediate medical intervention is recommended in such cases.

Pediatric Overdosage For children, the risk of severe liver damage arises if they take more than five doses of acetaminophen within a 24-hour timeframe. Healthcare providers should be vigilant in assessing pediatric patients for signs of overdose and liver impairment, and prompt action should be taken if overdosage is suspected.

Drug Interactions The concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to severe liver damage. Healthcare professionals should ensure that patients are not inadvertently exceeding the safe dosage by combining multiple products containing acetaminophen.

Alcohol Consumption Adults who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk of severe liver damage. It is advisable for healthcare providers to counsel patients on the dangers of alcohol consumption during acetaminophen therapy and to consider alternative pain management strategies if necessary.

In all cases of suspected overdosage, immediate medical evaluation and intervention are essential to mitigate the risk of severe liver injury.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that side effects may be reported voluntarily by healthcare professionals and patients. Reports can be submitted to the designated contact number, 1-888-952-0050. This information is collected through various surveillance programs to monitor the safety profile of the product.

Patient Counseling

Healthcare providers should advise patients to contact a doctor or the Poison Control Center (1-800-222-1222) immediately in the event of an accidental overdose. It is important to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Additionally, healthcare providers should instruct patients not to exceed the recommended dosage. This guidance is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 59º-86ºF (15º-30ºC).

Healthcare professionals should ensure that the product is not used if the imprinted safety seal under the cap is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Clear Choice Regular Strength Pain Reliever, 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 Clear Choice Regular Strength Pain Reliever, 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.