Chewable Aspirin

Description

The product is a low-dose chewable aspirin formulation, designed as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief. Each tablet contains 81 mg of active ingredient and is presented in an orange flavor. The packaging includes a total of 36 tablets. The National Drug Code (NDC) for this product is 53943-205-01.

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 for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must 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. Healthcare professionals should be vigilant for these signs in patients using this product.

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 disorders, 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.

It is contraindicated to use this product in individuals with a known allergy to any other pain reliever or fever reducer. Additionally, it should not be used for at least seven days following a tonsillectomy or oral surgery unless directed by a healthcare provider.

Before initiating use, patients should consult a physician if any of the following conditions apply: a history of stomach bleeding, existing stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or a history of asthma. Furthermore, it is advisable to seek guidance from a healthcare professional or pharmacist if the patient is 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 at 1-800-222-1222.

Patients should discontinue use and contact a physician 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 stomach pain that does not improve. Other reasons to seek medical attention include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, presence of redness or swelling, occurrence of new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these could indicate a serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concomitantly with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can increase the risk of bleeding.

Patients are advised to consult a healthcare professional prior to initiating aspirin therapy if they are currently prescribed medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use, as these conditions may influence the overall therapeutic strategy and risk profile associated with aspirin.

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 before use to ensure safety and appropriate dosing.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

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 the unborn child or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

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 its use in lactating individuals.

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 may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of blood pressure and heart function is also recommended, particularly in those with concurrent conditions such as high blood pressure or heart disease.

Healthcare providers should evaluate the overall health status of patients with hepatic impairment and consider potential interactions with other underlying conditions, including kidney disease, to ensure safe and effective use of the medication.

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 procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous assessment and monitoring of vital signs are recommended to ensure patient safety and to guide further therapeutic interventions.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Signs indicative of stomach bleeding that necessitate medical attention include feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain. Furthermore, the emergence of new symptoms such as tinnitus (ringing in the ears) or hearing loss may signal serious conditions that warrant consultation with a healthcare provider.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be cautioned against using the medication if they have a history of allergic reactions to any other pain reliever or fever reducer. 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 persistent stomach pain. Additionally, they should be advised to seek medical attention if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for 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. Patients with asthma should also seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are 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 important to retain the carton for reference to complete product information and any necessary warnings.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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.

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)