Acetaminophen

Description

VALUMEDS™ contains acetaminophen as its active ingredient, providing pain relief and fever reduction. Each tablet delivers 325 mg of acetaminophen. This product is classified as Regular Strength and is supplied in a bottle containing 100 tablets. The tablets are designed for effective pain management and are presented in their actual size for reference.

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 instructed 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 advice.

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 must not exceed 5 tablets, and use should not extend beyond 5 days unless directed by a physician.

For children under 6 years of age, it is advised to consult a doctor 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

This product contains acetaminophen, which poses significant risks if not used according to the recommended guidelines. 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.

Allergy Alert Acetaminophen may induce 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. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Monitoring and Follow-Up Patients should be instructed to discontinue use and contact a 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, as these may indicate a serious underlying condition.

Emergency Medical Help In the event of a skin reaction, it is crucial to stop using the product and seek emergency medical help immediately.

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 lead to 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.

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

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 in patients who may inadvertently exceed the recommended dosage of acetaminophen.

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 6 years of age should consult a healthcare professional before use. For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. Use should not exceed 5 consecutive days unless directed by a healthcare provider. In children under 12 years, if pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days, the medication should be discontinued and a healthcare professional should be consulted.

Geriatric Use

There is no specific information 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 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 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 a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using 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 healthcare providers to evaluate liver function prior to prescribing this product and to consider alternative therapies in patients with significant hepatic impairment.

Overdosage

In the event of overdosage, it is critical to adhere to the established dosage guidelines to prevent serious health consequences. 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 overdosage poses a significant risk of severe liver damage. This risk is heightened if an individual exceeds 4,000 mg of acetaminophen within a 24-hour timeframe. Additionally, the concurrent use of this product with other medications containing acetaminophen can lead to similar adverse effects, underscoring the importance of careful medication management.

Furthermore, individuals who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

In cases of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should assess the patient's condition and consider appropriate management strategies, which may include monitoring liver function and providing supportive care as necessary.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

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 whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is essential to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. 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 consult a doctor before using this medication if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes a carton with a neck wrap and a foil inner seal imprinted with "SAFETY SEAL®." It is essential to inspect the carton and seals prior to use; the product should not be utilized if the carton is opened or if the neck wrap or foil inner seal is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are crucial to ensure the integrity and safety of the product.

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)