Aspirin

Description

EQUAL INE® 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 flavored with orange and are packaged in a container that includes 36 chewable tablets. Each package features a tamper-evident seal; the product should not be used if the safety seal under the cap is broken or missing. EQUAL INE® is distributed by UNFI, located in Providence, RI 02908, USA, and is backed by a 100% quality guarantee.

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 recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours. The total daily intake must not exceed 48 chewable tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Patients are advised to drink a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness. Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole to ensure proper absorption.

For children under 12 years of age, the use of this medication is not recommended unless 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

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, as these may be early indicators of Reye's syndrome.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (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 is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic beverages daily while using this product, or are concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Patients should be counseled to adhere strictly to the recommended dosage and duration of use to minimize these risks.

Before initiating treatment, healthcare providers should inquire about the following conditions that may necessitate caution: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if the patient is taking diuretics.

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 advised to discontinue use and consult a healthcare professional 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. Additionally, patients should seek medical advice if they notice ringing in the ears, a loss of hearing, worsening pain lasting more than 10 days, a fever that persists beyond three days, any redness or swelling, or the emergence of new symptoms, as these may signal a serious condition requiring further evaluation.

Side Effects

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

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 help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, consume three or more alcoholic drinks daily while using the product, or are taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen. Patients should be advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain.

Patients are also advised to seek medical attention if they experience ringing in the ears or loss of hearing, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, 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, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients ask a doctor or pharmacist before use if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together, and patients should be monitored for signs of bleeding.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the risk of stomach bleeding when taken concurrently with the aforementioned medications. It is advisable for patients to consult their healthcare provider before combining these medications.

Patients who are on prescription medications for conditions such as gout, diabetes, or arthritis should seek medical advice to ensure safe and effective management of their treatment regimen.

No specific interactions with laboratory tests have been identified in the available data.

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, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, the product should not be used unless directed by a doctor. In contrast, adults and children aged 12 years and older may take 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 professional.

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 this medication to geriatric patients.

Monitoring for signs and symptoms 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 risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider 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 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 comorbid 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 degree 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 dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy.

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 symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring 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 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 identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, shock, and asthma (wheezing). Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, and those using other drugs containing prescription or nonprescription NSAIDs (e.g., aspirin, ibuprofen, naproxen).

Reports of serious conditions associated with aspirin use include the following: vomiting blood, bloody or black stools, feelings of faintness, persistent stomach pain, ringing in the ears or loss of hearing, worsening pain or pain lasting more than 10 days, fever that worsens or lasts more than 3 days, presence of redness or swelling, and the occurrence 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.

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. Special handling requirements are not specified; however, adherence to the recommended storage conditions is essential for maintaining product integrity.

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 directed by a healthcare provider.

Clinicians should counsel patients to consult with their doctor or healthcare provider prior to using this product, particularly for heart-related concerns. 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)