Acetaminophen 325mg

Description

Acetaminophen is provided in a dosage form of 325 mg per tablet. Each bottle contains 100 tablets. The product is identified by the National Drug Code (NDC) 10135-0123-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. 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 and children aged 12 years and over are instructed to take 2 tablets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless advised by a doctor.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total intake should not surpass 5 tablets in a 24-hour period.

For children under 6 years of age, it is advised to consult a healthcare professional before administration.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen. The maximum recommended daily dosage is 10 tablets (3,250 mg) within a 24-hour period. Healthcare professionals should advise patients that exceeding 4,000 mg of acetaminophen in 24 hours, using this product in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver damage.

Patients with a history of liver disease should be cautioned to consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms, as prompt intervention is essential for both adults and children.

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

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and exceeding the maximum daily dose of 10 tablets (3,250 mg) within a 24-hour period may lead to severe liver damage. This risk is heightened if patients take more than 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Those with known allergies to acetaminophen or any inactive ingredients in this product should also refrain from use.

Before using this product, patients should consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin, as interactions may occur.

Patients should discontinue use and seek medical advice 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, as these may indicate a serious condition.

In the event of an overdose, which may occur if the recommended dose is exceeded, patients must seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially 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 any 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 325mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. For children under 6 years of age, it is advised to consult a physician before administration.

In cases of overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, as liver disease may affect the safety and efficacy of the treatment. This product contains acetaminophen, and it is crucial to adhere to the maximum daily dosage of 10 tablets (3,250 mg) within a 24-hour period.

Patients with compromised liver function are at an increased risk of severe liver damage if they exceed 4,000 mg of acetaminophen in 24 hours, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Recommended Actions

In the case of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay, utilizing the national hotline at 1-800-222-1222. Prompt intervention is crucial, as timely medical attention can mitigate the risk of severe complications.

Management Procedures

Both adults and children require swift evaluation and management following an overdose, regardless of the presence of overt symptoms. Continuous monitoring and supportive care may be necessary to address any potential complications arising from the overdose. It is essential for healthcare professionals to remain alert to the possibility of delayed onset of symptoms, ensuring that all patients receive appropriate care.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases necessitating liver transplantation, particularly among patients who exceed the recommended dosage or utilize multiple acetaminophen-containing products. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been observations of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing renal conditions.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Additionally, healthcare providers should recommend that patients seek medical advice before using this medication if they have a history of liver disease.

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

Finally, healthcare providers should remind patients to consult with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a controlled temperature between 20-25 ˚C (68-77 ˚F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the product is kept in its original container to protect it from environmental factors. Additionally, the lot number and expiration date can be found on the end panel of the packaging, which should be checked regularly to ensure the product is used within its designated shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 325mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)