Aspirinlow Dose

Description

NDC 70882-122-30 indicates a blister package containing 30 enteric-coated tablets of low dose aspirin, each tablet delivering 81 mg of the active ingredient. This formulation serves as a pain reliever and is classified as a nonsteroidal anti-inflammatory drug (NSAID). The tablets are safety coated to enhance gastrointestinal tolerability. The product is tamper evident, and users are advised not to use it if the imprinted safety seal under the cap is broken or missing. This product is distributed by Cambridge Therapeutic Technologies, LLC, located in Teaneck, NJ, and packaged by Legacy Pharmaceutical Packaging, LLC, based in Earth City, MO. It is important to note that this product is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Bayer® Low Dose Aspirin.

Uses and Indications

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

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

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 should 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 doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. This is due to the potential for severe allergic reactions, which may pose significant health risks.

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 condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs 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 prolonged use beyond the recommended duration, concurrent use of blood thinners or steroid medications, being aged 60 or older, having a history of stomach ulcers or bleeding disorders, consuming three or more alcoholic beverages daily while using this product, or taking other medications that contain NSAIDs (e.g., aspirin, ibuprofen, naproxen).

Healthcare providers should advise patients to consult a physician 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 taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Immediate medical attention is also warranted for any allergic reactions, the emergence of new symptoms, ringing in the ears or hearing loss, worsening pain lasting more than 10 days, or the presence of redness or swelling.

Side Effects

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

Reye’s syndrome is a rare but serious condition that may 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 symptoms could indicate the onset of Reye's syndrome.

Aspirin may also provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction increases under certain conditions, including prolonged use beyond the directed dosage, concurrent use of blood thinners or steroid medications, being aged 60 or older, having a history of stomach ulcers or bleeding problems, consuming three or more alcoholic drinks daily while using the product, or taking other medications that contain NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, if new symptoms arise, or if patients notice ringing in the ears or loss of hearing, they should seek medical advice. Pain that worsens or lasts more than 10 days, as well as any redness or swelling, should also prompt a consultation with a healthcare provider.

Before using this product, patients should consult a doctor 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. Furthermore, patients taking prescription medications for gout, diabetes, or arthritis should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product may lead to an increased risk of severe gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or steroid medications. Caution is advised when this product is used alongside other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, as this may further elevate the risk of adverse effects.

Patients taking prescription medications for gout, diabetes, or arthritis should consult with a healthcare professional prior to using this product. Monitoring for potential interactions and adverse effects is recommended in these cases to ensure patient safety and therapeutic efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirinlow Dose (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 over 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, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing medications associated with gastrointestinal bleeding.

Healthcare providers should advise geriatric patients to consult a physician if they have a history of stomach ulcers or bleeding problems, especially in the context of the stomach bleeding warning. It is crucial to evaluate the potential benefits and risks of treatment in this population, ensuring that appropriate precautions are taken to mitigate the risk of adverse effects.

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 if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a healthcare provider, 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.

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 to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 identified several adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, asthma exacerbation, renal impairment, hepatic impairment, and skin reactions, which encompass Stevens-Johnson syndrome and toxic epidermal necrolysis. Additionally, cases of tinnitus and hearing loss have been documented.

Further safety updates from postmarketing experience indicate reports of Reye's syndrome in children and teenagers who have used aspirin during viral infections. There is also an increased risk of bleeding events in patients taking anticoagulants or those with a history of bleeding disorders.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additionally, patients should seek medical help promptly if they notice any allergic reactions, new symptoms, ringing in the ears, loss of hearing, worsening pain that lasts more than 10 days, or the presence of redness or swelling.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, those with asthma or who are taking a diuretic should consult a doctor before starting the medication. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are currently 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 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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