Aspirin

Description

CVS Health® Chewable Tablets contain 81 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. These adult low-dose tablets are designed for an aspirin regimen and are available in a convenient chewable form. Each bottle contains 36 chewable tablets, which are flavored with orange to enhance palatability. This product is comparable to the active ingredient found in Bayer® Chewable Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

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

Dosage and Administration

Patients should take each dose with a full glass of water to ensure proper administration.

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 should not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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 any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Aspirin has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: signs of an allergic reaction; symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; worsening pain that lasts longer than 10 days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or symptoms such as ringing in the ears or hearing loss, which may suggest a serious condition.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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 a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This 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 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 (including aspirin, ibuprofen, or naproxen), 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. Furthermore, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical advice, as these could be indicative of serious conditions.

Drug Interactions

Concurrent use of this product with other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, may increase the risk of adverse effects. Caution is advised, and monitoring for gastrointestinal or renal complications is recommended.

The use of this product alongside anticoagulants or steroid medications may enhance the risk of bleeding or other complications. Close monitoring of the patient's clinical status is warranted, and dosage adjustments may be necessary based on individual response and risk factors.

Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should use this product with caution. Regular monitoring of blood pressure and renal function is advised to mitigate potential risks.

Diuretic use in conjunction with this product may lead to electrolyte imbalances or renal impairment. Patients should be monitored for signs of dehydration and electrolyte disturbances.

Individuals with asthma should exercise caution when using this product, as it may exacerbate respiratory symptoms. Monitoring for respiratory function is recommended.

A history of gastrointestinal issues, such as heartburn, may increase the risk of adverse gastrointestinal effects when using this product. Patients should be advised to report any new or worsening gastrointestinal symptoms.

Consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver toxicity and gastrointestinal bleeding. Patients should be counseled to limit alcohol intake and to report any signs of liver dysfunction or gastrointestinal distress.

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

Packaging & NDC

Below are the non-prescription pack sizes of 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, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, consultation with a doctor is advised prior to use. For those aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This risk necessitates careful consideration when prescribing medications associated with gastrointestinal bleeding.

It is contraindicated to use this medication in patients with a history of stomach ulcers or bleeding problems, especially in the geriatric population.

Additionally, it is essential for healthcare providers to consult with elderly patients regarding any pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease prior to initiating treatment. This precaution is particularly important for patients aged 60 and older, as these conditions may exacerbate potential adverse effects.

Monitoring and dose adjustments may be warranted in this demographic to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 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 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 due to the potential impact of compromised liver function on the pharmacokinetics of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended 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 without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be cautioned against using this medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They should be instructed to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if patients notice 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. Additionally, patients should be advised to stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms arise. They should also be informed to stop use and consult a doctor if they experience ringing in the ears or a loss of hearing.

Patients should be encouraged to consult a doctor before using this medication if they have 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 before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients taking a diuretic or those with asthma should be advised to consult a doctor prior to use. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are currently 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 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 should be ensured to prevent any degradation of the product.

Additional Clinical Information

No additional information is available regarding laboratory tests, abuse information, or postmarketing experience.

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, consultation with a doctor is advised. Clinicians should counsel patients to discuss any heart-related concerns with their healthcare provider prior to using this product.

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.

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