Valumeds Extra Strength Pain Relief

Description

VALUMEDS EXTRA STRENGTH ACETAMINOPHEN is formulated as a caplet, each containing 500 mg of acetaminophen. This product is indicated for the relief of pain and the reduction of fever. It is available in a package size of 100 caplets.

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 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets 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 specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, 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.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of liver disease, as this may influence the safety and efficacy of the treatment. Additionally, individuals currently taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before initiating therapy, due to potential interactions that could affect coagulation parameters.

It is imperative for patients to discontinue use and contact their healthcare provider if any of the following occur: worsening pain that persists beyond 10 days, a fever that intensifies 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 immediate medical evaluation.

Side Effects

Patients should be aware of potential serious adverse reactions that may indicate a more severe underlying condition. These include worsening pain that persists for more than 10 days, a fever that intensifies or lasts longer than 3 days, the emergence of new symptoms, and the presence of redness or swelling.

Additionally, it is important for patients with liver disease to consult a healthcare professional prior to use. Patients who are currently taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist before initiating treatment.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Valumeds Extra Strength Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

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 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure safety and efficacy. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to manage potential risks effectively.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and clearance of the drug, necessitating careful consideration in their management. It is essential that these patients are monitored closely for any adverse effects throughout the course of treatment.

For individuals with moderate to severe hepatic impairment, dosage adjustments may be required to ensure safety and efficacy. Prior to initiating treatment, liver function tests should be conducted, and ongoing monitoring should continue during therapy in patients with known liver disease. In cases of significant hepatic dysfunction, a reduced dose may be warranted to mitigate potential risks associated with impaired liver function.

Overdosage

In the absence of specific details regarding overdosage for this medication (SPL code 34088-5), it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdosage.

Healthcare providers should be aware that symptoms of overdosage can vary widely depending on the substance involved. Common manifestations may include, but are not limited to, gastrointestinal disturbances, central nervous system effects, and cardiovascular abnormalities.

In the event of an overdosage, it is recommended that healthcare professionals take the following actions:

1. Assessment: Conduct a thorough assessment of the patient, including a detailed history of the substance taken, the amount, and the time of ingestion.

2. Supportive Care: Initiate supportive care as necessary, which may include monitoring vital signs, providing oxygen, and ensuring airway protection.

3. Decontamination: If the overdosage is recent, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Symptomatic Treatment: Manage symptoms as they arise, which may involve the use of specific antidotes if available and indicated.

5. Consultation: In cases of severe overdosage or uncertainty, consultation with a poison control center or a medical toxicologist is advised for further guidance.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events to the appropriate regulatory authorities.

Nonclinical Toxicology

The available data regarding teratogenic effects is not provided. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. There is no additional information available concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those who are taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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 Valumeds Extra Strength Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)