Bayer Aspirin Regimen Chewable

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 also consider other potential uses for Bayer 81 mg Orange Chewable Aspirin based on individual patient needs.

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 to ensure proper administration and absorption.

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, due to the risk of severe allergic reactions.

• Individuals who have undergone tonsillectomy or oral surgery within the past 7 days, unless specifically directed by a healthcare professional, to avoid complications during the recovery period.

• Patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to serious adverse effects.

Warnings and Precautions

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

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, 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, facial swelling, asthma (wheezing), or shock. Healthcare providers should be vigilant for these symptoms and advise patients to seek immediate medical attention if they occur.

Stomach Bleeding Warning 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 meet any of the following criteria:

• 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

Monitoring Parameters Patients should be instructed to discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, including:

• Feeling faint

• Vomiting blood

• Presence of bloody or black stools

• Persistent stomach pain that does not improve

• Worsening pain or pain lasting more than 10 days

• Redness or swelling

• Emergence of new symptoms

• Ringing in the ears or loss of hearing

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

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, 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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk 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 should 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 stomach pain that does not improve. Additional symptoms warranting medical attention include worsening pain lasting more than 10 days, the presence of redness or swelling, the occurrence of new symptoms, or ringing in the ears or loss of hearing.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concomitant use of these agents can increase the risk of bleeding or other adverse effects. It is advisable for healthcare providers to closely monitor patients for any signs of increased bleeding or other complications when these medications are used together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may also pose a risk when taken concurrently with anticoagulants or steroids. Patients should be advised to consult with their healthcare provider before initiating NSAID therapy to assess the potential for adverse interactions.

Furthermore, individuals taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional prior to starting any new medications. This precaution is essential to avoid potential interactions that could compromise treatment efficacy or safety. Regular monitoring and 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 Bayer Aspirin Regimen Chewable (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 may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a doctor is advised prior to use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

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 this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with overdose may include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate potential harm and manage the symptoms effectively.

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 associated with the use of the product. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, instances of stomach bleeding have been reported, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently taking certain medications. Symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, and persistent stomach pain, have also been documented. Furthermore, cases of ringing in the ears or loss of hearing have been noted.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Healthcare providers should 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 this medication 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 require immediate medical attention. Furthermore, they should be instructed to stop using the product and seek medical advice if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Patients should also report any redness or swelling, new symptoms, or occurrences of ringing in the ears or loss of hearing.

Lastly, it is advisable for patients to consult with a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in a carton that contains essential directions and warnings; therefore, it is important to retain the carton for reference. It should be stored at room temperature to maintain its integrity and effectiveness. Special handling requirements are not specified, but general care should be taken to ensure the product is kept in a suitable environment.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)