Aspirin

Description

NDC 21130-397-07. This product contains Low Dose Aspirin (81 mg) in the form of chewable tablets, designed as a pain reliever classified as a nonsteroidal anti-inflammatory drug (NSAID). The tablets are cherry-flavored and are packaged in a bottle containing 36 tablets. Users are instructed to chew or crush the tablets completely before swallowing. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. This formulation is not manufactured or distributed by Bayer AG, the distributor of Bayer® Chewable Low Dose Aspirin. It is distributed by Better Living Brands LLC, located at P.O. Box 99, Pleasanton, CA 94566-0009. Quality and satisfaction are guaranteed 100% or your money back.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and not exceed the recommended amount. Each dose should be accompanied by a full glass of water to ensure proper administration.

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

It is essential that the tablets are chewed or crushed completely before swallowing; swallowing the tablets whole is not advised.

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

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 ingredients are also advised against its use.

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare professionals should be vigilant for these symptoms 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 increases under certain conditions, including but not limited to: concurrent use of blood thinners or steroid medications, age 60 or older, use of other NSAIDs (prescription or nonprescription), consumption of three or more alcoholic drinks daily while using this product, a history of stomach ulcers or bleeding problems, or exceeding the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of asthma, if the stomach bleeding warning is applicable, if they have experienced stomach issues such as heartburn, if they are taking diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should be encouraged to 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 should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms warranting 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 indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Warnings 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. These individuals should not use 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.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

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 taking blood thinners or steroid medications, are aged 60 or older, are using other NSAIDs (including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, have a history of stomach ulcers or bleeding problems, or exceed the recommended dosage or duration of use.

Stop Use and Consult a Doctor Patients are advised to discontinue use and seek medical advice 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. Additionally, if patients notice ringing in the ears or a loss of hearing, if pain worsens or lasts more than 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, they should consult a healthcare professional, as these may be signs of a serious condition.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product raises concerns regarding potential drug interactions, particularly with anticoagulants and corticosteroids. The concomitant use of this product with blood thinners or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Therefore, it is advised that healthcare professionals closely monitor patients who are prescribed these combinations.

Additionally, caution is warranted when considering the use of this product in patients taking diuretics. It is recommended that individuals consult with their healthcare provider prior to use to ensure safety and appropriateness.

Furthermore, patients on prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before initiating this product. This precaution is essential to avoid any adverse interactions that may arise from the combination of therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. For children and teenagers who have or are recovering from chickenpox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye's syndrome, a rare but serious illness.

In the event of changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

For patients aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 chewable tablets in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential in this population to ensure safe and effective use of the medication.

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 outcomes or complications during delivery. Therefore, aspirin should only be used in this period if explicitly directed by a physician. 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of 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 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient in the event of an overdose.

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

No postmarketing experience details have been reported for SPL code 90375-7.

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 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 the product 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 necessitate urgent medical attention. They should also be instructed to stop using the product and seek medical advice if they notice any symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or a loss of hearing, if their pain worsens or persists beyond 10 days, if their fever intensifies or lasts more than 3 days, or if they observe any redness or swelling. They should also be advised to seek medical advice 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 asthma, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. It is also important to recommend that patients speak with a doctor before use if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Lastly, patients should be advised to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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 tracking and usage.

Additional Clinical Information

Patients aged 12 years and older are advised to take 4 to 8 chewable tablets orally every 4 hours, with a maximum of 48 chewable tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years, use is not recommended unless specifically directed by a doctor.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless explicitly instructed by a healthcare provider, 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)