Aspirin Low Dose Chewable Orange

Description

No description information is available for the specified drug.

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 also consider other potential uses for Chewable Aspirin 81 mg based on individual patient needs.

There are no teratogenic or nonteratogenic effects associated with this medication.

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 as needed. It is imperative not to exceed a total of 48 tablets within a 24-hour period unless specifically 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 known allergy to aspirin or any other pain reliever or fever reducer. 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.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. 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 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.

Healthcare providers should advise patients to consult a physician 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, kidney disease, or asthma. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before using this product.

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

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, presence of redness or swelling, ringing in the ears, loss of hearing, or any new symptoms. These may signify a serious condition requiring prompt medical 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 symptoms may 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, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of stomach bleeding 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, 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 an allergic reaction or symptoms indicative of stomach bleeding. These symptoms include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Additionally, if fever worsens or lasts more than three days, if redness or swelling is present, if there is ringing in the ears or loss of hearing, or if any new symptoms occur, medical attention should be sought promptly, as these could be signs of a serious condition.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin Low Dose Chewable Orange (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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use.

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 this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development 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 prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly mitigate potential adverse effects. It is essential for healthcare providers to be aware of the signs and symptoms associated with overdose, which may vary depending on the specific substance involved.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare professionals should be prepared to assess the patient's condition and provide appropriate interventions based on the severity of symptoms presented. Continuous monitoring and evaluation may be necessary to ensure patient safety and recovery.

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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 in the event of an accidental overdose. It is crucial to inform patients that they should not use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer.

Patients should be instructed to refrain from using the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They must be made aware that they should stop using the medication and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if patients notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Patients should also be advised to seek medical attention if fever worsens or lasts more than 3 days, if redness or swelling occurs, if they experience ringing in the ears or loss of hearing, or if any new symptoms arise, as these could indicate a serious condition.

Providers should encourage patients to consult with 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. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be advised to seek medical guidance prior to use. It is also important to recommend that patients taking a diuretic or any prescription drugs for gout, diabetes, or arthritis consult with their doctor or pharmacist before using this medication.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 15°C to 30°C. Healthcare professionals are advised to ensure that the safety seal under the cap is intact; the product should not be used if this seal is broken or missing. Proper handling and storage conditions are essential to maintain the integrity and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid 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.

Drug Information (PDF)

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

View product document (PDF)