Acetaminophen

Description

341R- Kroger Acetaminophen is presented in a dosage form of 500 mg per tablet. The product is available in various packaging configurations, including a 150-count label, a 100-count carton, a 2x500-count label, and a 500-count label. Each tablet contains acetaminophen as the active ingredient, which is utilized for its analgesic and antipyretic properties. The formulation is designed for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, 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 instructed 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. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

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

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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.

Additionally, this product is contraindicated 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

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.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should exercise caution and recommend that patients consult a physician prior to use if they have a history of liver disease. Additionally, it is advisable for patients to discuss their use of this product with a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as interactions may occur.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days in adults, fever intensifies or lasts longer than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, 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.

Patients are advised to stop use and consult a healthcare professional if pain worsens or persists for more than 10 days in adults, if fever worsens 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 are encouraged to seek advice from a doctor or pharmacist before 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 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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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. Treatment should not exceed 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, do not have specific recommendations or dosage adjustments outlined in the prescribing information. While there are no explicit safety concerns or special precautions mentioned for this population, it is important to consider the general health status of geriatric patients, who may frequently present with comorbidities.

Particularly, it is advised that elderly patients consult a healthcare provider prior to use if they have liver disease. This caution is relevant given the higher prevalence of liver conditions among older adults, which may necessitate careful monitoring and potential adjustments in treatment. Healthcare providers should remain vigilant in assessing the overall health and medication needs of geriatric patients to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function is advisable to ensure safe and effective use of the medication in this population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the risk of adverse effects in this patient population.

Overdosage

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

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, chronic alcohol consumption can exacerbate the potential for liver injury. Specifically, individuals who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should monitor liver function and consider appropriate interventions based on the severity of the situation. It is crucial to educate patients about the risks associated with exceeding recommended dosages and the dangers of combining acetaminophen with other acetaminophen-containing products or alcohol.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days in adults. Similarly, they should stop use and seek medical advice if their fever worsens or lasts more than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be advised to consult a doctor before using this medication. Additionally, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F), with permissible excursions between 15-30°C (59-86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)