Acetaminophen

Description

Acetaminophen Extended-Release Tablets USP, 650 mg, are indicated as a pain reliever and fever reducer, specifically formulated for the management of arthritis pain. Each tablet provides extended relief for up to 8 hours. The product is available in a package containing 24 extended-release tablets. The National Drug Code (NDC) for this formulation is 0363-9604-07, and it is distributed by Walgreens.

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 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 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 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 if this product is taken concurrently with other medications containing acetaminophen or if the individual consumes 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, it is imperative to discontinue use immediately and seek medical assistance.

Emergency Medical Help 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 apparent.

Consultation with Healthcare Provider Patients should stop taking this product and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition. Furthermore, individuals who are pregnant or breastfeeding should consult a healthcare professional prior to use.

Side Effects

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

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised 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. Additionally, individuals who are pregnant or breastfeeding should seek guidance from a healthcare provider 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. It is essential to evaluate 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 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.

To ensure safety, elderly patients should adhere to the recommended dosage guidelines, which stipulate a maximum of 6 tablets within a 24-hour period. Furthermore, it is important for geriatric patients to limit the duration of use to no more than 10 days unless otherwise directed by a healthcare professional. Regular monitoring and consultation with a healthcare provider are essential to mitigate risks and ensure appropriate management of their health conditions.

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 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and mitigate risks associated with acetaminophen use.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage 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 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 presented. Prompt recognition and management of overdosage are crucial to mitigate potential complications associated with liver injury.

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 question.

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 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 instructed to consult with their doctor prior to use if they have a history of liver disease. Additionally, it is important for patients to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking the blood-thinning medication warfarin.

Healthcare providers should inform patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to stop use and seek medical advice if their fever intensifies or lasts longer than 3 days. They should also be instructed to stop use and contact a healthcare professional if they experience new symptoms or if redness or swelling occurs, as these may indicate a serious condition.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using the medication.

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 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 are advised not to use the product if the carton has been opened or if the foil inner seal is broken, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

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 limited to 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 medical help or contact a Poison Control Center immediately, as prompt medical 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)