Clear Choice Extra Strength Pain Reliever

Description

Clear Choice Extra Strength is a pain reliever formulated to provide effective pain and fever relief. Each tablet contains 500 mg of acetaminophen, with a total of 100 tablets per bottle. This formulation is free from aspirin and caffeine, making it suitable for individuals seeking an alternative to traditional pain relief options. Clear Choice Extra Strength is manufactured for A.N.I. in Toledo, OH 436253.

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 utilized to temporarily reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are advised to take two tablets every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.

This product is contraindicated for use in children under 12 years of age, as administration in this population may result in an overdose, potentially leading to liver damage.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. It is also essential to adhere to the recommended dosage, as exceeding this may lead to serious health complications.

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 an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, consumes three or more alcoholic drinks daily while using this product, or takes other medications containing acetaminophen concurrently.

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

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

In cases of accidental overdose, immediate medical attention is crucial. Patients should be directed to contact a healthcare professional or the Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Patients should be advised to discontinue use and contact their healthcare provider if symptoms do not improve, if pain worsens or persists beyond 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, if redness or swelling occurs, or if any rare sensitivity reactions are observed.

Side Effects

Severe liver damage may occur in patients who exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, particularly if they are also taking other medications containing acetaminophen or consuming 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. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if symptoms do not improve, if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, if redness or swelling is observed, or if a rare sensitivity reaction occurs.

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

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking the anticoagulant warfarin. 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 Extra Strength Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it may lead to an overdose and potential liver damage. For adolescents aged 12 years and older, the recommended dosage is two tablets every 4 to 6 hours, with a maximum of 8 tablets in a 24-hour period. Careful adherence to these guidelines is essential to ensure safety and efficacy in this age group.

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 maternal health. 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of severe liver damage is heightened if this product is taken concurrently with other medications that also contain acetaminophen.

Patients with compromised liver function should be advised against the consumption of alcohol while using this product, as the risk of severe liver damage increases significantly with the intake of three or more alcoholic drinks per day. Therefore, careful consideration of liver function and potential interactions with other acetaminophen-containing products is essential to ensure patient safety. 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.

Risk of Severe Liver Damage Acetaminophen is known to pose a risk of severe liver damage when an adult ingests more than 4,000 mg within a 24-hour period. This risk is further compounded if the individual concurrently takes other medications that also contain acetaminophen.

Additionally, the potential for severe liver damage increases in individuals who consume three or more alcoholic beverages daily while using this product.

Recommended Actions Healthcare professionals should be vigilant in assessing patients for signs of acetaminophen overdosage, particularly in those who exceed the recommended dosage or have a history of alcohol use. Immediate medical intervention is crucial in managing suspected overdosage cases to mitigate the risk of liver injury.

Monitoring liver function tests and providing supportive care are essential components of the management strategy for patients presenting with acetaminophen overdosage.

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

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 800-326-8147. This information contributes to the ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical attention in the event of an accidental overdose. Patients should be informed to contact a doctor or the Poison Control Center at 1-800-222-1222 without delay. It is essential to emphasize that prompt medical intervention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose.

Additionally, healthcare providers should counsel patients on the importance of adhering to the recommended dosage. Patients must be cautioned against exceeding the prescribed amount to avoid potential adverse effects.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept within a temperature range of 59º-86ºF (15º-30ºC). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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