Extra Strength Pain Reliever

Description

VALUMEDS™ Extra Strength is a pain reliever formulation that combines acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. This product is designed to provide effective relief from pain. Each package contains 24 caplets, offering a convenient dosage form for users seeking pain relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual or menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage to avoid the risk of overdose.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. It is essential that each dose is accompanied by a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 8 caplets in a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product. Furthermore, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding, particularly in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

The recommended dosage of this product contains approximately the same amount of caffeine as a cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the warning regarding stomach bleeding applies, if they have a history of stomach issues such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or are taking diuretics. Patients with asthma should also seek medical advice before use.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help right away, regardless of whether signs or symptoms are present.

Patients should discontinue use and contact a healthcare provider if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), ringing in the ears or hearing loss, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or the emergence of any new symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions, which can vary in seriousness and frequency.

Serious adverse reactions include the risk of Reye's syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should seek medical attention immediately, as these may be early signs of this rare but serious condition.

Allergic reactions to the components of this product can also occur. Aspirin may lead to severe allergic responses, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Acetaminophen has been associated with severe skin reactions, including skin reddening, blisters, and rash. Patients experiencing any skin reactions should discontinue use and seek medical help promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using the product.

Additionally, the nonsteroidal anti-inflammatory drug (NSAID) component may increase the risk of stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk is further heightened if patients consume three or more alcoholic drinks daily or exceed the recommended duration or dosage.

Patients should be cautious regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

Before using this product, patients should consult a healthcare professional if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or other medications that may interact with this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Caution is advised when using this medication in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription. Patients should consult a healthcare professional prior to use if they are currently taking any NSAID.

Additionally, the use of this medication alongside anticoagulants or steroid drugs requires careful consideration. Patients should seek guidance from a healthcare provider if they are on blood thinners or steroids.

Patients prescribed medications for diabetes, gout, or arthritis should also consult their healthcare provider before using this medication to avoid potential interactions.

No specific laboratory test interactions have been identified in the available data. However, it is recommended that patients inform their healthcare provider of all medications they are taking and any serious medical conditions they may have to ensure safe and effective use of this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older are recommended to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is essential to seek medical advice before administration.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult their healthcare provider prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult their healthcare provider prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients with compromised liver function should be aware that exceeding 8 caplets in a 24-hour period, which is the maximum daily dosage, may lead to significant hepatic injury.

Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of 3 or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate the potential for severe liver injury. Monitoring of liver function may be warranted in patients with existing liver disease to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 the medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have ever experienced an allergic reaction to aspirin or any other pain reliever or fever reducer.

It is essential to instruct patients not to use this medication in conjunction with any other drug containing 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.

Patients should be advised to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be informed to discontinue use and consult a doctor if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Healthcare providers should also counsel patients to stop using the medication and contact a doctor if they experience ringing in the ears, loss of hearing, redness or swelling in the painful area, or if the pain worsens or persists for more than 10 days. Patients should be advised to seek medical advice if their fever worsens or lasts longer than 3 days, or if any new symptoms arise.

Patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should be encouraged to consult a doctor before using the medication. Furthermore, patients taking diuretics, those with asthma, or those on any other NSAID (whether prescription or nonprescription) should also seek medical advice prior to use.

Lastly, patients should be advised to consult a doctor or pharmacist if they are taking blood thinners (anticoagulants), steroid drugs, or prescription medications for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition.

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 room temperature, maintaining a range of 20° to 25° C (68° to 77° F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Extra Strength Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)