Aspirin

Description

CVP® is a formulation of aspirin, a nonsteroidal anti-inflammatory drug (NSAID), designed for use as a pain reliever and fever reducer. Each film-coated tablet contains 325 mg of the active ingredient, aspirin. The product is packaged in a quantity of 100 tablets.

A tamper evident warning is included, advising users not to use the product if the imprinted safety seal under the cap is broken or missing. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Genuine Bayer® Aspirin.

CVP® is distributed by Consumer Value Products, Inc., located at P.O. Box 6115, Temple, Texas 76502. Additional information can be found on the website www.CVPproducts.com.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, headache, muscle pain, menstrual pain, toothache, and pain and fever associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage.

For adults and children aged 12 years and older, the recommended dosage is as follows: take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless directed by a physician.

Patients are advised to consume a full glass of water with each dose to ensure proper administration and absorption of the medication.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

Warnings and Precautions

Children and teenagers who are experiencing or 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 any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Aspirin may induce severe allergic reactions, which can manifest as facial swelling, shock, hives, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic beverages daily while using this product, those with a history of stomach ulcers or bleeding disorders, and patients who exceed the recommended dosage or duration of use. Additionally, caution is advised for patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen.

Before using this product, patients should consult a healthcare provider if they are currently taking diuretics, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the patient is on prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling, or the emergence of new symptoms. These may indicate a serious condition requiring prompt medical evaluation.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience 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.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as facial swelling, shock, hives, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, those taking blood-thinning medications or steroids, individuals consuming three or more alcoholic drinks daily while using the product, and patients with a history of stomach ulcers or bleeding problems. Furthermore, the risk increases with prolonged use or higher dosages than directed, as well as concurrent use of other NSAIDs, whether prescription or nonprescription.

Patients are advised to stop using the product 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 stomach pain that does not improve. Other symptoms warranting medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling, or the emergence of new symptoms. These could indicate a serious condition requiring immediate attention.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the likelihood of stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating NSAID therapy if they are already on anticoagulants or steroids.

Patients taking diuretics should seek medical advice before using this medication to ensure safe co-administration. Furthermore, individuals on prescription medications for gout, diabetes, or arthritis are encouraged to consult with their healthcare provider or pharmacist prior to use to avoid potential interactions.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. For adolescents and adults aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a physician.

Caution is advised for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as they are at risk for Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare provider should be consulted immediately, as these may be early signs of this rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the likelihood of adverse gastrointestinal events may be heightened in this population.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to mitigate this risk. Regular assessment of the patient's overall health status and concurrent medications is recommended to ensure safe and effective treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later 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 the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as 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 a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored throughout the treatment process. It is advisable to follow established protocols for overdose management, which may include administering activated charcoal if appropriate and ensuring the patient’s safety during the recovery phase.

In summary, immediate action and appropriate medical intervention are critical in the case of an overdose to ensure the best possible outcome for the patient.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should stop using the product and contact a healthcare professional.

Furthermore, patients should be advised to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. They should also seek medical advice if they notice any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

Before using the product, patients should be encouraged to consult a doctor if they are taking a diuretic, if the warning for stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn. It is also important for patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma to seek medical advice prior to use. Lastly, patients should be advised to consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of pregnancy or later 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 Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)