Aspirin 81 mg

Description

This product is identified by NDC 69618-014-36 and contains Aspirin USP at a dosage strength of 81 mg per chewable tablet. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is formulated for adult low strength use as a pain reliever. The product is presented in an orange-flavored formulation and is packaged in a container of 36 chewable tablets. This formulation is comparable to the active ingredient found in the Aspirin Regimen BAYER® Chewable product.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses. The use of this drug should not exceed 10 days without medical consultation, as serious side effects may occur with prolonged use.

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

Dosage and Administration

Patients should drink a full glass of water with each dose.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed for symptom relief. However, the total dosage should not exceed 48 tablets within a 24-hour period.

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 administered for at least 7 days following a tonsillectomy or oral surgery to mitigate the risk of complications associated with these procedures.

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.

General Precautions This product should not be used by individuals with a known allergy to any other pain reliever or fever reducer. Additionally, it is contraindicated for use for at least 7 days following a tonsillectomy or oral surgery to prevent complications.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and seek medical advice if they experience any of the following symptoms, which may indicate serious conditions:

• Signs of stomach bleeding, including 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 for more than 3 days.

• Presence of redness or swelling in the area of pain.

• Emergence of any new symptoms.

• Ringing in the ears or loss of hearing.

Get Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, including the risk of Reye's syndrome. This condition is particularly concerning for 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 healthcare professional immediately, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious illness.

In addition to serious reactions, patients should be vigilant for signs of stomach bleeding. They are advised to stop use and seek medical attention if they experience any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, if pain persists for more than 10 days, fever worsens or lasts more than 3 days, redness or swelling occurs in the painful area, new symptoms develop, or if there is ringing in the ears or loss of hearing, patients should also consult a doctor.

Patients with a history of stomach problems, such as heartburn, or those with conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before using this product. Additionally, individuals taking diuretics or those with asthma should consult a healthcare professional prior to use.

It is also recommended that patients taking prescription medications for diabetes, gout, or arthritis, or those under a doctor's care for any serious condition, consult with a doctor or pharmacist before using this product.

Drug Interactions

Co-administration of aspirin with anticoagulant medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring for signs of bleeding in patients receiving this combination.

The concomitant use of aspirin with other non-steroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, may similarly increase the risk of stomach bleeding. It is advisable for patients to consult their healthcare provider prior to initiating or continuing this combination therapy.

Patients who are prescribed medications for diabetes, gout, or arthritis should seek medical advice before using aspirin, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg (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, 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 as needed, not exceeding 48 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions and consider the potential risks associated with the use of this medication in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to facilitate timely intervention if necessary.

Pregnancy

Aspirin is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of aspirin during pregnancy may be associated with significant risks, including fetal bleeding, premature closure of the ductus arteriosus, and other complications that could adversely affect fetal outcomes.

Pregnant patients are advised to avoid the use of aspirin unless specifically directed by a healthcare professional. The safety of aspirin during pregnancy has not been established, and dosage adjustments may be necessary based on individual circumstances. Therefore, it is essential for women of childbearing potential to consult a healthcare provider before using aspirin during pregnancy to ensure appropriate management and minimize potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of aspirin in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Therefore, healthcare professionals may consider the use of aspirin in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 should be cautioned against using the medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use the medication for at least 7 days following a tonsillectomy or oral surgery.

Healthcare providers should instruct patients to stop using the medication 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. Patients should also be advised to seek medical attention if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise. Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or loss of hearing, as these could indicate a serious condition.

Patients should be encouraged to ask a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also essential to advise patients to consult a doctor before using the medication if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic. Patients with asthma should also seek medical advice prior to use.

Additionally, healthcare providers should recommend that patients consult a doctor or pharmacist before using the medication if they are taking a prescription drug for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition. Lastly, patients should be advised to check with a doctor or pharmacist before using the medication if they are taking any other drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a temperature range of 15º to 30ºC (59º to 86ºF). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Aspirin 81 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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