Chewable Aspirin

Description

Marc's® is a low-dose, orange-flavored chewable aspirin formulation, indicated as a pain reliever classified under nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 81 mg of active ingredient, and the product is packaged in a bottle containing 36 tablets. The National Drug Code (NDC) for this formulation is 68998-205-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Healthcare providers may consider additional uses for this product based on individual patient needs.

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 physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such adverse effects is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

General precautions should be observed. This product should not be used by individuals with a known allergy to any other pain reliever or fever reducer. It is also contraindicated for use within seven days following a tonsillectomy or oral surgery unless directed by a healthcare professional. Prior to use, individuals should consult a physician if any of the following conditions apply: a history of stomach bleeding, heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than ten days, fever that worsens or persists beyond three days, presence of redness or swelling, emergence of new symptoms, or occurrences of ringing in the ears or hearing loss. These symptoms may signify a serious medical condition requiring prompt attention.

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, 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 feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical attention, as these could be indicative of a serious condition.

Drug Interactions

Patients taking anticoagulants or steroid medications should exercise caution when using this drug, as there may be an increased risk of bleeding or other adverse effects. It is advisable for these patients to consult with a healthcare professional prior to initiating therapy.

The concomitant use of this drug with nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may enhance the risk of gastrointestinal bleeding and other related complications. Monitoring for signs of gastrointestinal distress is recommended.

Additionally, individuals who are on prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist before using this drug. This is to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or increased monitoring.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye’s syndrome.

For dosing recommendations, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is essential to consult a doctor prior to use.

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 this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about any relevant medical history that may heighten the risk of gastrointestinal complications. Close monitoring of these patients is advised to ensure safety and to mitigate potential adverse effects associated with the use of this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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 before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy 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 in lactating mothers.

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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be cautioned against using the medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, or if they observe any redness or swelling. New symptoms, ringing in the ears, or loss of hearing should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients should be encouraged to ask a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also essential for patients to consult a healthcare provider if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic. Furthermore, patients with asthma should seek medical advice before use, as well as those taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product information.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)