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 consider additional 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 for optimal efficacy.

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 that the total daily dosage does not exceed 48 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is essential 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, 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, asthma, or if they are taking diuretics. Additionally, patients should be encouraged to discuss their use of prescription medications for gout, diabetes, or arthritis with their healthcare provider or pharmacist before starting 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 be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling, or any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include worsening pain lasting more than 10 days, fever persisting beyond three days, the presence of redness or swelling, ringing in the ears, loss of hearing, or any new symptoms, as these may signify a serious condition.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions. 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, an allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical assistance promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction 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 may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs, medical attention should be sought. Patients should also report any new symptoms, including ringing in the ears or loss of hearing, as these could signify 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 any 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 may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years, consultation with a doctor is required before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

The use of aspirin during pregnancy, particularly in the last trimester, is associated with potential risks to the unborn child and complications during delivery. Pregnant patients should avoid the use of aspirin during the final three months of pregnancy unless specifically directed by a healthcare professional. This precaution is critical to mitigate any adverse fetal outcomes and ensure maternal safety during labor and delivery. Healthcare providers should carefully evaluate the necessity of aspirin therapy in pregnant patients and consider alternative treatments when appropriate.

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 the use of this medication in lactating individuals.

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 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 accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national Poison Control Center can be reached at 800-222-1222.

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 remain vigilant and prepared to address any symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information.

Management procedures should be initiated based on the clinical presentation of the patient and the specific substance involved in the overdose. Continuous monitoring and supportive care 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 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms, asthma exacerbation, renal impairment, hepatic impairment, and skin reactions including rash and urticaria.

Reports of gastrointestinal adverse events have included ulceration, perforation, and hemorrhage. Additionally, there have been cases of severe allergic reactions characterized by hives, facial swelling, and shock.

The incidence of these adverse reactions may be heightened in patients with specific risk factors, including those aged 60 years or older, individuals with a history of stomach ulcers or bleeding problems, patients concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs), and those with chronic alcohol use.

Furthermore, additional postmarketing reports have suggested a potential association between high doses of aspirin and the occurrence of tinnitus and hearing loss.

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 for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

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 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 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, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, 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)