Acetaminophen

Description

Acetaminophen Tablets USP are formulated as film-coated tablets, each containing 500 mg of acetaminophen. The product is identified by the National Drug Code (NDC) 65437-040-31 and is manufactured under the code Guj/Drugs/G/1362. The total quantity of the product is 31,000 tablets. It is labeled for distribution by HIMPRIT PHARMACHEM PVT. LTD, located at "LAKULISH", R.V. Desai Road, next to Navapura Police Station, Baroda, India – 390 001. The manufacturing date, expiration date, and lot number are specified on the packaging. Caution is advised as the product is intended for manufacturing, processing, or repacking purposes.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, the common cold, menstrual cramps, muscular aches, arthritis, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours as needed. The maximum allowable dosage is 8 caplets within a 24-hour period.

For children under 12 years of age, the use of this adult Extra Strength product is contraindicated, as it may result in an overdose that could lead to serious health complications.

Contraindications

Use of this product is contraindicated in patients who are concurrently using any other product that contains acetaminophen. This is due to the potential risk of acetaminophen overdose, which can lead to serious liver damage.

Warnings and Precautions

Taking more than the recommended dose of this medication can lead to serious health complications, including liver damage. In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients who consume three or more alcoholic beverages daily should consult their healthcare provider before using acetaminophen or other pain relievers and fever reducers, as acetaminophen has the potential to cause liver damage.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to using this medication to ensure safety for both the mother and child.

In the case of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a physician if any of the following occur:

• Fever worsens or persists for more than three days.

• Redness or swelling develops.

• Pain intensifies or lasts longer than ten days.

• New symptoms arise.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include the potential for liver damage, particularly in cases of overdose. It is critical for patients to seek immediate medical attention or contact a Poison Control Center if they suspect an overdose, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Additionally, patients who consume three or more alcoholic beverages daily should consult their healthcare provider before using acetaminophen or other pain relievers/fever reducers, due to the increased risk of liver damage associated with concurrent alcohol consumption.

Common adverse reactions warranting discontinuation of use include the following: if fever worsens or persists for more than three days; if redness or swelling occurs; if pain intensifies or lasts longer than ten days; or if new symptoms arise. In such cases, patients are advised to stop use and consult a healthcare professional for further evaluation and guidance.

Drug Interactions

The concomitant use of alcohol with acetaminophen may elevate the risk of liver damage. This risk is particularly significant in individuals who consume three or more alcoholic beverages daily. It is advisable for patients to limit alcohol intake while using acetaminophen to mitigate the potential for hepatotoxicity. Monitoring of liver function may be warranted in patients with a history of alcohol use or those consuming high amounts of alcohol.

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 12 years of age should not use this adult Extra Strength product, as it may result in doses exceeding the recommended levels, leading to potential overdose and serious health complications. Caution is advised to prevent the administration of this product to children within this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 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 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 drug insert text 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 to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when considering the use of acetaminophen or other pain relievers and fever reducers. It is crucial to adhere to the recommended dosage, as exceeding this can lead to serious health complications, including liver damage.

Additionally, patients who consume three or more alcoholic drinks daily are advised to consult their healthcare provider before using acetaminophen. The combination of excessive alcohol intake and acetaminophen can significantly increase the risk of liver damage. Therefore, careful assessment of liver function and potential interactions is essential for this patient population.

Overdosage

Taking more than the recommended dose of this medication can lead to serious health complications, particularly liver damage. It is essential for healthcare professionals to be aware of the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, emphasizing the importance of vigilance even in the absence of noticeable signs or symptoms.

Prompt medical evaluation and management are vital to mitigate the risks associated with overdosage and to ensure patient safety.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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, as this may lead to an increased risk of adverse effects.

Patients should be instructed to stop using the medication and consult a doctor if any of the following occur: if fever worsens or persists for more than three days, if there is any redness or swelling, if pain intensifies or lasts longer than ten days, or if new symptoms develop. This guidance is crucial for ensuring patient safety and effective management of their condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets every 6 hours as needed, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, this adult Extra Strength product is not recommended, as it may lead to an overdose and serious health issues.

Clinicians should counsel patients who consume 3 or more alcoholic drinks daily to consult their doctor before using acetaminophen or other pain relievers, due to the risk of liver damage. Additionally, pregnant or breastfeeding patients should seek professional advice prior to use.

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)