Acetaminophen

Description

Acetaminophen is the active ingredient in this formulation, presented in the form of Extended-Release Tablets, USP, each containing 650 mg of acetaminophen. This medication is indicated for the relief of pain and reduction of fever. The duration of action is up to 8 hours, providing sustained relief. The product is packaged in a container of 50 caplets, which are capsule-shaped tablets.

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 caplets every 8 hours with water. The caplets should be swallowed whole and must not be crushed, chewed, split, 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 individuals under 18 years of age, it is recommended to consult a doctor before use.

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 another medication, 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.

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 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 drinks daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

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

In cases of overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain lasting more than 10 days, fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets 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, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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 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 18 years of age should consult a healthcare professional prior to 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. 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 potential for altered pharmacokinetics and pharmacodynamics in this population.

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 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.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on therapy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary 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 products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, 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. Similarly, they should stop use and seek medical advice if their fever worsens or lasts longer 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 a tamper-evident container. It is essential to inspect the imprinted seal on the bottle; do not use the product if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25° C (68 to 77° F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F).

Additionally, the carton should be retained, as it contains important information pertinent to the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the recommended dosage for adults being 2 caplets every 8 hours, taken with water. It is important to swallow the caplets whole and not to crush, chew, split, or dissolve them. Patients should not exceed 6 caplets in a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if they have liver disease or are taking the blood-thinning medication warfarin. Additionally, pregnant or breastfeeding patients should seek advice from a health professional prior to use. Patients are advised to discontinue use and consult a doctor if their pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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)