Acetaminophen

Description

Acetaminophen Extended-Release Tablets USP contain 650 mg of acetaminophen per tablet. These tablets are formulated for the temporary relief of minor arthritis pain and function as both a pain reliever and fever reducer. Each container contains 24 extended-release tablets. Caution is advised as 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 minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, and toothache. Additionally, this drug 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 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 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, 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 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.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Emergency Medical Help 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 if no signs or symptoms are apparent.

Monitoring and Consultation Patients should be advised to stop taking the 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, pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic skin responses. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage of 6 tablets is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if consumed with 3 or more alcoholic drinks daily.

In addition to liver-related concerns, there is an allergy alert associated with acetaminophen. Patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative that the patient discontinue use and seek medical assistance immediately.

Patients are advised to stop using the product and consult a healthcare professional if they experience worsening pain that lasts more than 10 days, a fever that persists or worsens beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. 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.

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 18 years of age should consult a healthcare professional before use. In the event of an overdose, it is critical to seek immediate medical attention for children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for these patients to consult a healthcare provider prior to use, especially if they have a history of liver disease.

Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating treatment with this medication, as potential interactions may necessitate careful monitoring.

For adults, including elderly patients, the maximum recommended dosage is 6 tablets within a 24-hour period. Furthermore, it is important to note that the medication should not be used for more than 10 days unless directed by a healthcare professional. Adhering to these guidelines is essential to ensure safety and efficacy in the geriatric 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 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 minimize the risk of severe liver damage.

Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can significantly increase the risk of liver injury.

Furthermore, patients who consume three or more alcoholic drinks daily should exercise extreme caution, as this behavior may also lead to severe liver damage when using this product. Regular assessment of liver function is recommended for patients with compromised liver function to ensure safety and efficacy.

Overdosage

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

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 6 tablets within a 24-hour period, which is the maximum recommended daily dosage. Additionally, the risk of liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should monitor liver function and consider appropriate interventions based on the severity of the symptoms and the amount ingested. Prompt recognition and management of overdosage are crucial to mitigate potential complications.

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 use. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued and medical assistance 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, as prompt medical attention is crucial 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 essential to instruct patients to avoid using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the product. Additionally, patients should be advised to consult a doctor before using this medication if they have liver disease.

Patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist prior to initiation.

Healthcare providers should instruct patients to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies 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.

Finally, patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using this medication.

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 20 to 25 °C (68 to 77 °F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40 °C (104 °F).

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

Patients should be informed that the medication is administered orally. For adults, the recommended dosage is 2 tablets every 8 hours, taken with water. Tablets should be swallowed whole and not crushed, chewed, split, or dissolved. Patients should not exceed 6 tablets 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 who are pregnant or breastfeeding to consult a health professional before use. Additionally, patients must be made aware of the overdose warning; in the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are present.

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)