Aspirin

Description

SoundBody™ LOW DOSE Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) formulated as a pain reliever, containing 81 mg of aspirin per tablet. The product is presented in a dosage form of enteric-coated tablets, with a total of 120 tablets per bottle. The enteric coating is designed to enhance gastrointestinal safety. The product is tamper evident; it should not be used if the imprinted safety seal under the cap is broken or missing. SoundBody™ LOW DOSE Aspirin is distributed by LNK International, Inc., located at 60 Arkay Drive, Hauppauge, NY 11788, USA. The National Drug Code (NDC) for this product is 50844-563-32.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets within a 24-hour period unless otherwise directed by a physician.

It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

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

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 in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases under certain conditions, including but not limited to: concurrent use of other NSAIDs (prescription or nonprescription), being aged 60 or older, exceeding the recommended dosage or duration of use, having a history of stomach ulcers or bleeding disorders, consuming three or more alcoholic beverages daily while using this product, or taking anticoagulants or steroid medications.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are 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 are advised to discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. Furthermore, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three 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. It is crucial for these individuals to avoid this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms may indicate the onset 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, shock, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who are taking other medications that contain NSAIDs, are aged 60 or older, exceed the recommended dosage or duration of use, have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily while using the product, or are taking blood-thinning (anticoagulant) or steroid medications.

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

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increases the risk of severe gastrointestinal bleeding. This risk is particularly heightened when NSAIDs such as aspirin, ibuprofen, or naproxen are taken alongside other NSAIDs, whether prescription or nonprescription.

Additionally, the use of anticoagulants or steroid medications concurrently with NSAIDs also elevates the likelihood of severe stomach bleeding. Healthcare professionals should exercise caution and consider monitoring patients closely when these medications are prescribed together.

Patients are advised to consult with a healthcare provider or pharmacist prior to initiating treatment if they are currently taking prescription medications for conditions such as gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of the medications involved.

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, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, the product should not be used unless directed by a doctor. In contrast, for adults and children aged 12 years and older, the recommended dosage is 4 to 8 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. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the patient's history of stomach problems, including heartburn, as well as any existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may necessitate a more thorough evaluation and consideration of alternative therapies or dosage adjustments to mitigate potential adverse effects.

Close monitoring of elderly patients is advised to ensure safety and efficacy, particularly in those with pre-existing gastrointestinal or systemic conditions.

Pregnancy

Pregnant patients and women 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, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

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 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 of their liver function to ensure safe 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 be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers are advised to follow established protocols for overdose management, which may include the administration of activated charcoal, intravenous fluids, or other interventions as deemed necessary based on the clinical presentation.

In summary, timely medical intervention and appropriate management strategies are critical in addressing overdose situations effectively.

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 demonstrated that aspirin may be associated with severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, it has been reported that the use of aspirin may result in severe stomach bleeding, particularly in specific populations. These populations include individuals who are concurrently using other medications containing prescription or nonprescription NSAIDs (such as aspirin, ibuprofen, or naproxen), those aged 60 years or older, individuals who exceed the recommended dosage or duration of use, patients with a history of stomach ulcers or bleeding disorders, those consuming three or more alcoholic beverages daily while using aspirin, and individuals taking anticoagulant or steroid medications.

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 crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must 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 vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and contact their healthcare provider.

Furthermore, patients should be informed 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 worsens or lasts more than 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. It is also important to advise patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease to seek medical advice prior to use. Patients with asthma or those taking a diuretic should also be encouraged to consult a doctor before using this product. Lastly, patients should be advised 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 configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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.

View product document (PDF)