Valumeds Aspirin

Description

VALUMEDS™ contains aspirin as its active ingredient, providing a regular strength formulation for pain relief. Each tablet is designed as a safety-coated formulation to help protect against stomach upset. The product is available in a bottle containing 500 tablets, with each tablet delivering 325 mg of aspirin. This nonsteroidal anti-inflammatory drug (NSAID) is comparable to the active ingredient found in ECOTRIN® TABLETS*.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, minor arthritis pain, toothache, menstrual pain, and colds. It may also be used as recommended by a healthcare professional.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 to 2 tablets every 4 hours as needed while symptoms persist. Each dose should be accompanied by a full glass of water to ensure proper hydration and absorption.

It is imperative that patients do not exceed 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

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

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of this product.

Warnings

Reye’s Syndrome: This product is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If any 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.

Allergy Alert: Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. The likelihood of this adverse effect is heightened in individuals who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using anticoagulants or steroid medications

• Are taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use.

General Precautions: Prior to use, patients should consult a healthcare provider if any of the following conditions apply:

• The individual has a history of stomach issues, such as heartburn

• There is a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease

• The patient is taking diuretics

• The individual has asthma.

Additionally, it is advisable to seek guidance from a healthcare professional or pharmacist if the patient is currently taking prescription medications for diabetes, gout, or arthritis.

Emergency Medical Help: In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1(800)222-1222.

Discontinuation of Use: Patients should stop taking this product and contact a healthcare provider if any of the following occur:

• Signs of an allergic reaction, which require immediate medical attention

• Symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days

• Presence of redness or swelling

• Any new symptoms arise

• Ringing in the ears or loss of hearing occurs.

These symptoms may signify a serious medical condition and warrant prompt evaluation by a healthcare professional.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Aspirin, an active ingredient in this product, may provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical assistance without delay.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts more than 10 days. Additionally, any new symptoms, redness or swelling, or symptoms such as ringing in the ears or loss of hearing should prompt immediate medical consultation, as these could indicate a serious condition.

Before using this product, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or prescription medications for diabetes, gout, or arthritis should also consult a doctor or pharmacist prior to use.

Drug Interactions

Patients taking anticoagulants or steroid medications should exercise caution when using this drug, as there is a potential for increased bleeding risk. It is advisable for these patients to consult with a healthcare professional prior to initiating therapy.

The concomitant use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, may also elevate the risk of adverse effects, particularly gastrointestinal bleeding. Patients are encouraged to seek guidance from a healthcare provider before combining these medications.

Additionally, individuals on prescription medications for diabetes, gout, or arthritis should consult their doctor or pharmacist prior to using this drug to ensure safe and effective treatment. Monitoring and dosage adjustments may be necessary based on the specific medications involved and the patient's overall health status.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Valumeds Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 1 to 2 tablets every 4 hours as needed, with a maximum of 12 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, it is advised to consult a doctor before use.

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 before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development 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 health 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 mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, shock, facial swelling, and asthma (wheezing). Additionally, cases of stomach bleeding have been noted, particularly among individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious conditions associated with aspirin use have also been reported. These include signs of stomach bleeding, characterized by symptoms such as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Furthermore, new symptoms have been documented, including tinnitus (ringing in the ears) and hearing loss.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1(800)222-1222 in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or any of the following symptoms indicative of potential stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, noticing worsening pain that lasts more than 10 days, observing redness or swelling, developing any new symptoms, or experiencing ringing in the ears or loss of hearing. These symptoms may signify a serious condition that requires prompt medical attention.

It is important for healthcare providers to recommend that patients consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Additionally, those taking diuretics or who have asthma should be encouraged to discuss their situation with a healthcare professional.

Patients should be reminded to consult a doctor or pharmacist before using the product if they are currently taking prescription medications for diabetes, gout, or arthritis, as potential interactions may exist.

Storage and Handling

The product is supplied in a configuration that includes a tamperevident feature. It is essential to ensure that the printed inner seal beneath the cap is intact; the product should not be used if this seal is missing or broken.

For optimal storage conditions, the product must be kept at temperatures below 25°C (77°F) to maintain its integrity and efficacy. Proper handling and storage are crucial to ensure the product remains safe for use.

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. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, 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 Valumeds Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)