Low Dose Aspirin

Description

QC® QUALITY CHOICE Low Dose Aspirin 81 mg Chewable Tablets are formulated as chewable tablets containing 81 mg of aspirin as the active ingredient. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for pain relief. The tablets are designed to be chewed or crushed completely before swallowing. Each package contains 36 chewable tablets.

The product is tamper evident, and users are advised not to use it if the imprinted safety seal under the cap is broken or missing. This product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Chewable Low Dose Aspirin. It is distributed by CDMA, Inc., located at 43157 W Nine Mile, Novi, MI 48375. For further information, visit www.qualitychoice.com or contact customer service at 800-935-2362. A satisfaction guarantee is provided, ensuring 100% satisfaction.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

There are no teratogenic or nonteratogenic effects associated with 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 4 to 8 chewable tablets every 4 hours. The total daily intake must not exceed 48 chewable tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Patients are advised to drink a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness. It is essential that the tablets are chewed or crushed completely before swallowing; swallowing the tablets whole is not recommended.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional, as this may increase the risk of complications. Furthermore, individuals who have previously experienced an allergic reaction to this product or any of its components should avoid its use to prevent potential adverse effects.

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, as these may be early indicators of Reye's syndrome.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (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 patients who are taking anticoagulants or steroid medications, are aged 60 years or older, are using other NSAIDs (including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, have a history of stomach ulcers or bleeding problems, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to using this product if they have asthma, if the stomach bleeding warning is applicable, if they have a history of gastrointestinal issues such as heartburn, if they are taking diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling, or if they notice symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should not use this product in such cases, and if changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor immediately, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (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 may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are taking blood thinners or steroid drugs, are aged 60 or older, consume three or more alcoholic drinks daily while using the product, have a history of stomach ulcers or bleeding problems, or take other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen. Patients should be vigilant for signs of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop use and consult a doctor.

Additional adverse reactions may include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling, or the emergence of new symptoms. These could indicate a serious condition, and medical advice should be sought.

Patients with a history of asthma, stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor before using this product. Furthermore, those taking prescription medications for gout, diabetes, or arthritis should also seek guidance from a healthcare professional prior to use.

It is particularly important for patients to avoid using aspirin at 20 weeks of pregnancy or later unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), is associated with an increased risk of severe stomach bleeding. This risk is particularly heightened in certain populations and under specific conditions.

Patients who are concurrently using anticoagulants or steroid medications should be closely monitored due to the potential for enhanced bleeding risk. Additionally, individuals aged 60 years or older, those consuming three or more alcoholic beverages daily, and patients with a history of stomach ulcers or bleeding disorders are at an elevated risk. It is advised that these patients avoid prolonged use or higher-than-recommended dosages of this NSAID.

Furthermore, caution is warranted when this product is used in conjunction with other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, as this may further increase the likelihood of gastrointestinal complications.

Prior to initiating therapy with this product, patients should consult a healthcare provider if they are currently taking diuretics, medications for gout, diabetes, or arthritis. Monitoring and potential dosage adjustments may be necessary based on the specific medications involved and the patient's overall health status.

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the product should not be used unless directed by a doctor. For those aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 chewable tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 gestation 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 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 to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy.

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’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 that they should not 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 for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients must be made aware that they should discontinue use and consult a doctor if they experience any signs of an allergic reaction, which may necessitate immediate medical attention. They should also be instructed to stop use and seek medical advice if they notice symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain.

Furthermore, patients should be informed 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 persists beyond 3 days. Any signs of redness or swelling, or the emergence of new symptoms, should also prompt a consultation with a healthcare provider, as these could indicate a serious condition.

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

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements are not specified; however, maintaining the recommended storage conditions is essential for product integrity.

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 critical to avoid the use of aspirin after 20 weeks 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 Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)