Acetaminophen

Description

Acetaminophen Extended-Release tablets are formulated to provide a dosage of 650 mg of acetaminophen per tablet. Each carton contains 100 tablets, and the product is identified by the National Drug Code (NDC) 68001-495-00. The tablets are designed for extended-release, allowing for prolonged therapeutic effects. The packaging includes a container label that also bears the same NDC for consistency in identification.

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, premenstrual and menstrual cramps, the common cold, headache, and toothache. 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 instructed to take 2 tablets orally every 8 hours with water. The tablets must be swallowed whole and should 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 individuals under 18 years of age, it is recommended to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Patients with liver disease should consult a healthcare professional prior to use, as the product may exacerbate liver conditions.

• Caution is advised for patients taking the anticoagulant warfarin; consultation with a doctor or pharmacist is recommended before use to avoid potential interactions.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings regarding liver health. 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 when acetaminophen is taken in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily while using this product.

Healthcare professionals should be aware of the potential for severe skin reactions associated with acetaminophen. 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.

In cases of overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition.

Furthermore, it is recommended that individuals who are pregnant or breastfeeding consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use, particularly those related to acetaminophen.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can 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 should also be instructed to stop use and consult a healthcare professional 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 is observed. These symptoms may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of bleeding complications. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the 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 18 years of age should consult a healthcare professional before use. It is essential to assess the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general variability in drug metabolism and sensitivity in this population. Individualized assessment and clinical judgment are essential when considering treatment options for elderly patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 exercise caution 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, as exceeding this limit may result in severe liver damage.

Additionally, patients must be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is significantly increased for patients who consume 3 or more alcoholic drinks daily while using this product. 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. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms 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, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed to verify whether any medication they are taking contains acetaminophen by consulting with a doctor or pharmacist. It is essential to instruct patients not to use the product if they have a known allergy to acetaminophen or any of the inactive ingredients.

Healthcare providers should recommend that patients consult a doctor before using the medication if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days. They should also be advised to stop use and seek medical advice if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Finally, healthcare providers should remind patients who are pregnant or breastfeeding to consult a health professional before using the product.

Storage and Handling

The product is supplied in a carton that must remain sealed until use. It is essential to store the product at a temperature range of 20º to 25ºC (68º to 77ºF) and to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

Healthcare professionals should ensure that the carton remains unopened and that the foil inner seal is intact prior to use, as the product should not be utilized if either of these conditions is not met.

Additional Clinical Information

The medication is administered orally, with adults advised to take 2 tablets every 8 hours with water. Patients should swallow the tablets whole and must not crush, chew, split, or dissolve them. The maximum dosage is 6 tablets within a 24-hour period, and use should not exceed 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 important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

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)