Acetaminophen

Description

Acetaminophen is provided in the form of extended-release tablets, USP, each containing 650 mg of the active ingredient. This formulation serves as a pain reliever and fever reducer, specifically indicated for the temporary relief of minor arthritis pain. The product is packaged in a container containing 225 extended-release tablets. It is important to note that this medication should not be used concurrently with other medicines that contain acetaminophen to avoid potential overdose.

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 advised 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 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 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 within the formulation.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings regarding its 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 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Healthcare professionals should be vigilant for symptoms such as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Emergency Medical Help In the event of an overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay (1-800-222-1222).

Monitoring and Consultation Patients should be advised to stop taking the product and consult their healthcare provider if any of the following occur: worsening pain that lasts 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 signs may indicate a serious underlying condition.

Pregnancy and Breastfeeding Healthcare professionals should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to using this product.

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 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. 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. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare professional if there is any uncertainty. This precaution is essential to avoid the risk of acetaminophen overdose, which can lead to serious liver damage.

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 important 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 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 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 exercise caution when using this product, which contains acetaminophen. The maximum recommended dosage is 6 tablets within a 24-hour period; 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 in patients who consume 3 or more alcoholic drinks daily while using this product. 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, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products It is essential to caution patients against the concurrent use of this product with other medications that also contain acetaminophen. Such combinations can lead to an increased risk of severe liver damage.

Alcohol Consumption Patients should be informed that the consumption of 3 or more alcoholic drinks daily while using this product may also result in severe liver damage. Healthcare providers should assess patients' alcohol intake and provide appropriate guidance.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate management strategies, which may include the administration of N-acetylcysteine as an antidote, depending on the severity of the situation.

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. Reported symptoms may 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. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially 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 the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should also inquire about any known allergies to acetaminophen or any of the inactive ingredients in the product, as this could contraindicate its use. Additionally, patients with liver disease should be advised to consult a doctor before using this medication.

It is essential to discuss the potential interaction with the blood-thinning medication warfarin, and patients should be instructed to seek guidance from a doctor or pharmacist if they are currently taking this medication.

Patients should be counseled to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if new symptoms develop, or if any redness or swelling occurs.

Finally, pregnant or breastfeeding patients should be advised to consult a healthcare professional prior to using this medication to ensure safety for themselves and their child.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Healthcare professionals are advised to inspect the packaging prior to use. The product should not be utilized if the carton is opened or if the foil inner seal is broken, as this may compromise the integrity and safety of the product. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults, the recommended dosage is 2 tablets every 8 hours, with a maximum of 6 tablets in a 24-hour period. Patients should swallow the tablets whole and avoid crushing, chewing, splitting, or dissolving them. The use of this medication should not exceed 10 days unless directed by a healthcare professional. For individuals under 18 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from 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 must seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

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)