Acetaminophen

Description

Acetaminophen is an active pharmaceutical ingredient formulated as Extended-Release Tablets, USP, designed for the temporary relief of minor arthritis pain. Each tablet contains 650 mg of acetaminophen and is presented in a capsule-shaped form. The product is packaged in a container of 100 caplets and is distributed by Safeway Inc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, headache, toothache, the common cold, 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 are advised to take 2 caplets every 8 hours with water. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved. The maximum dosage should not exceed 6 caplets 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 18 years of age, it is recommended to consult a doctor before administration.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Patients who have difficulty swallowing large tablets or capsules should not use this product. This is particularly relevant for individuals over the age of 65, who may experience increased difficulty in swallowing.

• The product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within this formulation.

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 the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic beverages daily while taking this product.

Patients with liver disease should be cautioned to consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: the tablet becomes lodged in the throat, pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 caplets within 24 hours, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should not use this product if they are taking any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications. Additionally, individuals who have difficulty swallowing large tablets or capsules, particularly those over 65 years of age, should avoid this product. It is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the blood-thinning medication warfarin are advised to consult a doctor or pharmacist prior to use.

Patients are instructed to discontinue use and consult a doctor if the tablet becomes lodged in the throat, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen may interact with warfarin, a blood-thinning medication. This interaction can potentially enhance the anticoagulant effect of warfarin, leading to an increased risk of bleeding. It is advisable for healthcare providers to monitor patients closely for signs of bleeding and to consider adjusting the dosage of warfarin as necessary when acetaminophen is used concurrently. Regular INR (International Normalized Ratio) monitoring is recommended to ensure that anticoagulation remains within the therapeutic range.

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 18 years of age should consult a healthcare professional prior to use. It is essential for healthcare providers to evaluate the appropriateness of treatment in this population, considering potential differences in efficacy and safety profiles compared to adults.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may experience difficulty swallowing the tablets. It is advisable for healthcare providers to assess the swallowing ability of geriatric patients prior to prescribing this medication.

Additionally, it is important to consult a physician before use in patients with liver disease, as this may necessitate dosage adjustments or increased monitoring for potential adverse effects.

In the event of an overdose, prompt medical attention is critical for both adults and children. Healthcare providers should ensure that elderly patients and their caregivers are aware of the signs of overdose and the importance of seeking immediate medical help if such an event occurs.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of 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, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which may result from taking more than the recommended dose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can be critical in mitigating the risks associated with excessive dosing.

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 rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases resulting in liver transplant or death, particularly among patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been reported in the postmarketing setting. Furthermore, there have been reports of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing renal conditions.

Patient Counseling

Patients should be advised about the risks associated with overdose. It is important to communicate that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients must seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Storage and Handling

The product is supplied in a container that is tamper evident. It should not be used if the imprinted seal is broken or missing from the bottle.

For optimal storage, the product must be kept at a temperature range of 20 to 25° C (68 to 77° F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

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 experiences.

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)