Aspirin

Description

Equaline® is a chewable tablet formulation containing 81 mg of aspirin as the active ingredient. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for pain relief. The tablets are cherry-flavored and are packaged in a count of 36. Equaline® is distributed by UNFI, located in Providence, RI 02908, USA, and is backed by a 100% quality guarantee. A tamper evident warning is included, advising against use if the imprinted safety seal under the cap is broken or missing. This product is comparable to Bayer® Chewable 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 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 components should avoid its use to prevent potential adverse effects.

Warnings and Precautions

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using 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.

Allergy Alert Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

Stomach Bleeding Warning 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 the following circumstances:

• Concurrent use of blood thinners (anticoagulants) or steroid medications.

• Patients aged 60 years or older.

• Use of other medications containing NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen).

• Consumption of three or more alcoholic beverages daily while using this product.

• A history of stomach ulcers or bleeding disorders.

• Exceeding the recommended dosage or duration of use.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply:

• A history of stomach problems, including heartburn.

• Existing high blood pressure, heart disease, liver cirrhosis, or kidney disease.

• A diagnosis of asthma.

• Use of diuretics.

Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center.

Discontinuation of Use Patients should be instructed to stop using this product and contact a healthcare provider if any of the following occur:

• Signs of an allergic reaction, which require urgent medical attention.

• Symptoms indicative of stomach bleeding, such as vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain.

• Ringing in the ears or loss of hearing.

• Worsening pain that lasts longer than 10 days.

• Fever that worsens or persists beyond three days.

• Presence of redness or swelling.

• Onset of new symptoms.

These signs may indicate a serious medical condition that requires prompt evaluation.

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 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.

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 (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 may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction 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.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other symptoms that warrant medical attention 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.

Drug Interactions

The concomitant use of blood thinners (anticoagulants) or steroid medications increases the risk of severe stomach bleeding. Healthcare professionals should exercise caution when prescribing these medications together and consider monitoring for gastrointestinal bleeding.

Patients taking prescription medications for gout, diabetes, or arthritis are advised to consult with a healthcare provider or pharmacist prior to initiating treatment. This precaution is essential to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

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

For pediatric patients under 12 years of age, the product should not be used unless directed by a healthcare professional. For those 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 doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 and symptoms of gastrointestinal bleeding is advised in geriatric patients, especially when initiating treatment or adjusting dosages. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to ensure safe and effective use of the therapy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy 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 a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment. Additionally, patients with concurrent conditions such as high blood pressure or heart disease may require further evaluation to ensure safe and effective use of the medication.

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 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 substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly in older patients, those taking blood thinners or steroids, individuals who consume alcohol regularly, and patients with a history of stomach ulcers or bleeding disorders.

Adverse reactions documented in postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, feelings of faintness, and persistent stomach pain. Other adverse reactions reported include tinnitus or hearing loss, exacerbation of pain, prolonged fever, localized redness or swelling, and the emergence of new symptoms.

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 for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety and well-being.

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 tracking and usage. Special handling requirements should be adhered to in order to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 chewable tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, use is not recommended unless under a doctor's guidance.

Clinicians should counsel patients to consult with their healthcare provider prior to using this product, particularly for heart-related issues. It is important for patients to chew or crush the tablets completely before swallowing to ensure proper administration.

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)