Buffered Aspirin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including toothache, minor pain of arthritis, backache, the common cold, headache, muscular aches, and premenstrual and menstrual cramps. Additionally, this drug is indicated for the temporary reduction of fever.

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.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

It is essential to take each dose with a full glass of water to ensure proper hydration and facilitate the medication's effectiveness.

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

Patients are cautioned against exceeding the recommended dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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 may provoke severe allergic reactions, which can manifest as shock, hives, asthma (wheezing), or facial swelling. Healthcare professionals should be vigilant for these signs and ensure that patients are aware of the potential for such reactions.

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 individuals who have a history of stomach ulcers or bleeding problems, consume three or more alcoholic beverages daily while using the product, are aged 60 or older, take anticoagulants or steroid medications, or use other NSAIDs (including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen). Patients should be advised to adhere strictly to the recommended dosage and duration of use.

Before initiating treatment, healthcare providers should inquire about the following conditions: a history of stomach problems (such as heartburn), asthma, or if the patient is taking diuretics, has high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, it is advisable to consult a doctor or pharmacist if the patient is currently taking prescription medications for gout, diabetes, or arthritis.

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 seek medical attention if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms warranting immediate medical consultation include ringing in the ears, hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, visible redness or swelling, or the emergence of new symptoms, as these may signify a serious underlying condition.

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 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.

Aspirin may also cause severe allergic reactions in some patients, which can manifest as shock, hives, asthma (wheezing), or facial swelling. In such cases, immediate medical attention is necessary.

Additionally, 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 have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily while using the product, are aged 60 or older, take blood-thinning (anticoagulant) or steroid medications, or use other drugs containing prescription or nonprescription NSAIDs, such as aspirin, ibuprofen, or naproxen. Patients should also be cautious if they take the product for longer than directed.

Patients are advised to stop using the product and seek medical attention if they experience any signs of an allergic reaction or stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or the emergence of new symptoms, as these could indicate a serious condition.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, asthma, or if they are taking diuretics. It is also advisable to seek medical advice if patients have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients taking prescription medications for gout, diabetes, or arthritis should consult a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Buffered Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a physician.

Caution is advised for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as the use of this product in these populations may be associated with Reye’s syndrome, a rare but serious condition. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare provider should be consulted promptly, as these may be early signs of Reye's syndrome.

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 medications that may exacerbate this risk in this population.

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 benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

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 fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a physician if deemed necessary.

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, 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 its use 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 of liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 assess the patient thoroughly and consider the pharmacological profile of the substance involved.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should ensure that the patient is stabilized and may need to implement specific protocols based on the substance and the severity of the overdose. Continuous monitoring of vital signs and supportive measures should be prioritized to ensure patient safety.

In summary, immediate medical attention is critical in cases of overdose, and healthcare professionals should be prepared to provide comprehensive care based on the individual circumstances of the patient.

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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as shock, hives, asthma (wheezing), and facial swelling. Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly in patients with a history of stomach ulcers or bleeding disorders, those who consume three or more alcoholic drinks daily, individuals aged 60 years or older, and patients taking blood-thinning (anticoagulant) or steroid medications, as well as other drugs containing prescription or nonprescription NSAIDs. Furthermore, adverse reactions reported in the postmarketing experience include tinnitus (ringing in the ears) and hearing loss.

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 essential to inform patients not to use the 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 if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should stop using the product and contact a healthcare professional.

Furthermore, patients should be advised 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. They should also seek medical advice if they notice any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with asthma, those taking diuretics, or individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Lastly, patients taking prescription medications for gout, diabetes, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, use is not recommended unless specifically directed by a healthcare provider.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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