Bayer Chewable - Aspirin Regimen

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Healthcare providers may consider additional uses for Bayer 81 mg Cherry Chewable Aspirin based on individual patient needs and circumstances.

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

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must 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 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. 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 condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. 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 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, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if any of the following conditions apply: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or a history of asthma.

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

Patients should be instructed to discontinue use and contact their healthcare provider 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), persistent stomach pain, worsening pain lasting more than 10 days, redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

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 chickenpox 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 healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may occur, presenting as hives, facial swelling, asthma (wheezing), or shock. 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 severe 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, 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 should discontinue use and seek medical attention 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. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should consult a healthcare provider 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. Additionally, patients taking diuretics or those with asthma should seek medical advice prior to use. It is also advisable for patients to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Children under 12 years should consult a doctor before using this product. It is important to note that 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, a doctor should be consulted, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious illness.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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 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 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 the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 revealed reports of various adverse reactions. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, instances of stomach bleeding have been reported, particularly among patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using other NSAIDs or anticoagulants. Changes in behavior accompanied by nausea and vomiting have also been noted, which may represent early signs of Reye’s syndrome in children and teenagers recovering from chickenpox or flu-like symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. It is also important to communicate that this product should not be used for at least 7 days following a tonsillectomy or oral surgery unless directed by a healthcare professional. Patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Healthcare providers should instruct patients to discontinue use and seek medical attention if they experience any signs of an allergic reaction. Additionally, patients should be made aware of the symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Patients should also be advised to seek medical help if redness or swelling occurs, new symptoms develop, or if they experience ringing in the ears or a loss of hearing.

Providers should encourage patients to consult with a doctor before using this product if the stomach bleeding warning applies to them. It is also essential to ask patients about their medical history, particularly if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also be advised to consult a doctor prior to use. Furthermore, patients should be encouraged to speak with a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in a carton that contains essential information, including full directions and warnings, which should be retained for reference. It is recommended to store the product at room temperature to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Bayer Chewable - Aspirin Regimen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)