Regular Strength Pain Relief

Description

VALUMEDS™ contains acetaminophen at a dosage of 325 mg per softgel. It is indicated as a pain reliever and fever reducer. Each package contains 10 softgels, with the actual size of the softgels provided for reference.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, 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 softgels every 4 to 6 hours as needed while symptoms persist. The maximum allowable dosage is 10 softgels within a 24-hour period. Continuous use should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours while symptoms last. The total daily limit for this age group is 5 softgels, and usage should not extend beyond 5 days unless instructed by a physician.

For children under 6 years of age, it is recommended 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, 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.

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• In pediatric patients for the treatment of arthritis pain, unless specifically directed by a healthcare provider, to ensure appropriate management and safety.

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 use.

Warnings

The maximum daily dose for adults is limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily amount.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions

Prior to use, it is advisable to consult a healthcare provider if the user has a history of liver disease. Furthermore, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help Instructions

In the event of an overdose, immediate medical attention is necessary. Contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Stop Taking and Call Your Doctor Instructions

Users should discontinue use and consult a healthcare professional 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 develop.

• 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 the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. The risk of liver damage is further heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is also contraindicated for individuals with a known allergy to acetaminophen or any of the inactive ingredients in the formulation. Additionally, this product should not be administered to children for the treatment of arthritis pain unless specifically directed by a healthcare professional.

Patients should discontinue use and consult a doctor if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 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 requiring medical evaluation.

Prior to use, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of 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 Regular Strength Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be given this product for the pain of arthritis unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours as needed for symptom relief, with a maximum of 5 softgels in a 24-hour period. This medication should not be used for more than 5 consecutive days unless advised by a doctor.

For children under 6 years of age, consultation with a healthcare provider is required before administration.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of liver disease. The potential for altered drug metabolism in this population necessitates careful consideration and monitoring.

Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist before initiating treatment. The interaction between this medication and warfarin may require dose adjustments or increased monitoring to ensure safety and efficacy.

In the event of an overdose, prompt medical attention is crucial for both elderly patients and children. This underscores the importance of adhering to recommended dosages and being vigilant about potential signs of overdose.

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 the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising women of childbearing potential.

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 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 absence of detailed guidance 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 limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. It is critical to note that severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within 24 hours.

• A child exceeds the maximum daily amount of 5 doses in 24 hours.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, patients with liver disease are advised to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications.

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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions 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 medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is essential to inform patients not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Additionally, healthcare providers should caution against administering this product to children for the treatment of arthritis pain unless specifically directed by a physician.

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. They should also be advised to stop use and consult a doctor if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease. Patients taking the blood-thinning medication warfarin should also be advised to seek guidance from a doctor or pharmacist prior to using this product.

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

View product document (PDF)