Acetaminophen

Description

VALUMEDS is a pharmaceutical product formulated for pain relief and fever reduction, containing acetaminophen as its active ingredient at a dosage of 325 mg per tablet. This product is comparable to the active ingredient found in Regular Strength Tylenol®. Each bottle contains 100 tablets, designed for oral administration. The formulation is intended to provide effective relief from pain and to reduce fever.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including 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 older are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days without medical supervision.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake should not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

In the case of children under 6 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

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, and it is crucial for healthcare professionals to be aware of the associated warnings and precautions to ensure safe usage.

Warnings

The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, it is restricted to 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Furthermore, it is recommended that patients taking the anticoagulant warfarin seek guidance from a doctor or pharmacist before using this product.

Monitoring Parameters

While no specific laboratory tests are required for monitoring, healthcare providers should remain vigilant for signs of adverse reactions or complications associated with acetaminophen use.

When to Seek Medical Attention

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults, pain worsens or lasts more than 5 days in children under 12 years, 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 that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three 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.

Patients are advised to stop use and consult a healthcare professional if pain worsens or persists for more than 10 days in adults, more than 5 days in children under 12 years, or if fever worsens or lasts more than 3 days. Additionally, the emergence of new symptoms or the presence of redness or swelling may indicate a serious condition, warranting medical evaluation.

Individuals with liver disease should consult a doctor prior to using this product. Furthermore, patients taking the blood-thinning medication warfarin are encouraged to seek advice from a healthcare provider or pharmacist before use.

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 nonprescription. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. Monitoring for signs of liver damage is advised in patients who may inadvertently exceed the recommended acetaminophen dosage.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Use should not exceed 5 consecutive days unless directed by a healthcare professional. For children under 6 years, consultation with a doctor is advised prior to use.

If pain worsens or persists for more than 5 days in children under 12 years, or if fever worsens or lasts more than 3 days, the use of this medication should be discontinued, and a healthcare professional should be consulted.

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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 individuals with reduced kidney function, as the lack of information 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 exercise caution when using this product, which contains acetaminophen. The maximum daily dose for adults is 10 tablets (3,250 mg) within a 24-hour period, while for children, it is limited to 5 tablets (1,625 mg) in the same timeframe.

It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Due to the potential for increased risk of hepatotoxicity, patients with compromised liver function should be closely monitored for signs of liver damage and may require dosage adjustments. It is advisable for these patients to consult with a healthcare professional before initiating treatment to ensure safe use and appropriate management of their condition.

Overdosage

In the event of overdosage, it is critical to adhere to the established dosage guidelines to prevent serious health risks. The maximum recommended daily dose for adults is 10 tablets, equating to 3,250 mg, while for children, the limit is 5 tablets, or 1,625 mg, within a 24-hour period.

Acetaminophen is known to pose a significant risk of severe liver damage when consumed in excess of 4,000 mg within a 24-hour timeframe. This risk is further exacerbated when acetaminophen is taken concurrently with other medications that also contain acetaminophen. Healthcare professionals should be vigilant in assessing the total acetaminophen intake from all sources to mitigate the risk of hepatotoxicity.

Additionally, the consumption of three or more alcoholic beverages daily while using this product can increase the likelihood of severe liver damage. It is advisable for healthcare providers to counsel patients on the dangers of combining alcohol with acetaminophen-containing products.

In cases of suspected overdosage, immediate medical attention is warranted. Management may include supportive care and monitoring of liver function, as well as the consideration of N-acetylcysteine as an antidote in cases of significant overdose. Prompt intervention is essential to minimize the risk of irreversible liver injury.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has revealed rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were identified through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years. Additionally, if a patient experiences a fever that worsens or lasts more than 3 days, they should stop using the medication and consult a doctor.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. Furthermore, it is important to advise patients to seek medical guidance before using this product if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to ensure that the carton remains unopened and that the neck wrap or foil inner seal, which is imprinted with "SAFETY SEAL," is intact. If the carton is opened or the safety seal is broken or missing, the product should not be used.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)