Acetaminophen

Description

CVSHealth® Tablets are formulated as extended-release tablets containing 650 mg of acetaminophen, classified as a pain reliever and fever reducer. Each bottle contains 24 extended-release tablets. The product is identified by NDC 69842-635-07. It is important to note that these tablets should not be used in conjunction with other medications that contain acetaminophen.

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 tablets every 8 hours with water. The tablets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 tablets within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product. It is crucial to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk due to concurrent medication use or alcohol consumption.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Healthcare professionals should advise patients to discontinue use immediately and seek medical assistance if any of these symptoms occur.

Emergency Medical Help In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Monitoring and Follow-Up Patients should be instructed to stop taking the product and consult their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Pregnancy and Breastfeeding Patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six tablets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any presence of redness or swelling. These symptoms may indicate a serious underlying condition. Additionally, individuals who are pregnant or breastfeeding should seek guidance from a healthcare provider prior to using this product.

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 toxicity. 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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 8 hours with water, with a maximum of 6 tablets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare professional.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately 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.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 8 hours with water, with a maximum of 6 tablets in a 24-hour period. Geriatric patients should not exceed this dosage or use the medication for more than 10 days unless directed by a healthcare professional. Close monitoring is advised to ensure safety and to mitigate any adverse effects, particularly in those with underlying health conditions or those taking multiple medications.

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 drug 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 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. It is critical to adhere to the maximum daily dosage of 6 tablets within a 24-hour period to avoid the risk of severe liver damage.

Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, individuals who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, it is advisable for patients with compromised liver function to consult with a healthcare professional before using this product to ensure safe and appropriate use.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product.

Maximum Daily Dosage Healthcare professionals should advise patients that exceeding the maximum recommended dosage of 6 tablets within a 24-hour period significantly increases the risk of severe liver damage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential for healthcare providers to review all medications a patient is taking to prevent potential interactions.

Alcohol Consumption Patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using this product, as this behavior further elevates the risk of liver damage.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate management strategies based on the severity of the symptoms presented.

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

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to consult with their doctor before using the medication if they have liver disease. Additionally, it is essential for patients to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking the blood-thinning drug warfarin.

Patients should be informed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should stop using the medication and seek medical advice if their fever worsens or lasts longer than 3 days. New symptoms, as well as any signs of redness or swelling, should also prompt patients to stop use and contact their healthcare provider.

For patients who are pregnant or breastfeeding, it is crucial to recommend that they consult a health professional before using the medication to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Healthcare professionals are advised not to use the product if the carton has been opened or if the foil inner seal is broken, as this may compromise the integrity and safety of the product. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally every 8 hours with water, ensuring the tablets are swallowed whole without crushing, chewing, splitting, or dissolving. The maximum dosage should not exceed 6 tablets within a 24-hour period, and use should not extend beyond 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)