Chewable Aspirin

Description

No description information is available for the drug.

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

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 ingredients are also advised against its use.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use 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 induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare providers should be vigilant for these symptoms and advise patients to seek immediate medical attention if they 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 is increased in patients who:

• Are taking anticoagulants or steroid medications

• Are aged 60 years or older

• Are using other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen

• Consume three or more alcoholic beverages daily while using this product

• Have a history of stomach ulcers or bleeding disorders

• Exceed the recommended dosage or duration of use

General Precautions Patients should consult a healthcare provider 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, or kidney disease

• Asthma

• Use of diuretics

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

Discontinuation and Consultation Patients should discontinue use and contact a healthcare professional 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 more 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 condition that necessitates further 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 symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction increases 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 an allergic reaction or symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms. These could be indicative of serious underlying conditions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Chewable Aspirin (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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome.

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended, 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 therapy.

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 development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a 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 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, heart disease, or liver cirrhosis 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may occur.

Management of an overdose should be guided by clinical judgment and may involve supportive care, symptomatic treatment, and specific interventions as deemed necessary based on the patient's condition and the substance involved. Continuous assessment and monitoring of the patient are recommended to ensure appropriate management and to address any complications that may arise.

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

No postmarketing experience details are available in the insert text.

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 crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients must be made aware that they should discontinue use and consult a doctor if they experience any signs of an allergic reaction, which may include symptoms such as difficulty breathing or swelling. They should also be instructed to stop use and seek medical attention if they notice any signs of stomach bleeding, including vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or a loss of hearing, if their pain worsens or lasts longer than 10 days, if their fever worsens or lasts more than 3 days, or if they observe any redness or swelling. It is important to advise patients to seek medical advice if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product 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. Additionally, patients with asthma or those taking diuretics should consult a healthcare professional before using the product. Lastly, it is recommended that patients taking prescription medications for gout, diabetes, or arthritis discuss their use of this product with a doctor or pharmacist.

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, maintaining the recommended storage conditions is essential for product integrity.

Additional Clinical Information

Adults and children aged 12 years and older are advised to 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 physician. For children under 12 years, use is not recommended unless specifically directed by a healthcare professional.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless explicitly instructed by a healthcare provider, 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.

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