Acetaminophen

Description

VALUMEDS™ Regular Strength contains acetaminophen as the active ingredient, with each tablet delivering 325 mg of acetaminophen. This formulation is indicated for the relief of pain and reduction of fever. The product is supplied in a package containing 40 tablets.

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 while symptoms persist. 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 last. 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 doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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.

Additionally, this product is contraindicated 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 risks and recommended 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, concurrent 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, which 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.

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 and Follow-Up

Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: pain worsens or persists beyond 10 days in adults, pain 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.

No specific laboratory tests are required for monitoring the use of this product; however, vigilance in observing the aforementioned symptoms is essential for patient safety.

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 that acetaminophen may cause severe skin reactions, which can 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 for more than 10 days in adults, or for more than 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, these may indicate a serious condition requiring medical evaluation.

Patients with liver disease should consult a doctor prior to use. Furthermore, individuals taking the blood-thinning medication warfarin are encouraged to seek advice from a doctor or pharmacist before 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. Monitoring for signs of liver damage is advised if acetaminophen is used concurrently.

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 in a 24-hour period. Treatment should not exceed 5 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 the medication should be discontinued, and a healthcare professional should be consulted.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For elderly patients, it is crucial to adhere to the recommended dosage guidelines. The maximum dosage should not exceed 10 tablets within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, the duration of use should not extend beyond 10 days unless advised by a doctor, to minimize the risk of adverse effects and ensure appropriate monitoring of the patient's condition.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 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 in patients with compromised liver function, careful monitoring of liver function tests is recommended. Adjustments to dosing or additional restrictions may be necessary based on the severity of hepatic impairment.

Overdosage

In the event of overdosage, it is critical to recognize the potential risks associated with excessive intake of this product. The maximum recommended daily dosage 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.

Risks of Overdosage

Taking more than 4,000 mg of acetaminophen within a 24-hour timeframe can lead to severe liver damage. This risk is further compounded if the product is used concurrently with other medications that contain acetaminophen. Additionally, individuals who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions

Healthcare professionals should monitor patients for symptoms of liver damage, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. In cases of suspected overdosage, immediate medical attention is warranted. It is advisable to initiate supportive care and consider the administration of N-acetylcysteine as an antidote for acetaminophen toxicity, particularly if the overdose is identified within a critical time frame.

Prompt recognition and management of overdosage are essential to mitigate the risk of severe hepatic injury and ensure patient safety.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 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 of age. 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 their 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 inspect the packaging prior to use. The product must not be utilized if the carton is opened or if the neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing, as this may compromise the product's safety and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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)