Lil Drug Store Aspirin 325

Description

Regular Strength Aspirin is formulated as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 325 mg of aspirin. The product is packaged in a bottle containing 100 tablets and is marketed under the Lil' Drug Store® brand.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, muscle pain, menstrual pain, toothache, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever related to colds.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 1 or 2 tablets every 4 hours, or alternatively, 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be administered to patients who have a history of allergic reactions to this product or any of its components.

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 during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, consume three or more alcoholic beverages daily while using the product, exceed the recommended dosage or duration of use, take other medications containing NSAIDs (including aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding disorders, or are on anticoagulant or steroid medications.

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of gastrointestinal issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, individuals with asthma or those for whom the stomach bleeding warning is applicable should seek medical advice. Patients taking prescription medications for gout, diabetes, or arthritis should also consult a healthcare provider or pharmacist before using this product.

In the event of an allergic reaction, immediate medical assistance should be sought. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should discontinue use and contact a physician if they experience any signs of stomach bleeding, including vomiting blood, feeling faint, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to stop use include worsening pain lasting more than 10 days, the presence of redness or swelling, a fever that worsens or persists beyond three days, the emergence of new symptoms, or occurrences of ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial that these individuals do not use this product. 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.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, consume three or more alcoholic drinks daily while using the product, take higher doses or use it for longer than directed, use other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, or are on blood-thinning (anticoagulant) or steroid medications.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, feeling faint, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, if an allergic reaction occurs, medical help should be sought immediately. Patients should also seek medical advice if pain worsens or persists for more than 10 days, if redness or swelling is present, if fever worsens or lasts more than three days, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Patients are advised not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer, or if they have previously experienced an allergic reaction to this product or any of its ingredients.

Before using this product, patients should consult a doctor if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if the stomach bleeding warning applies to them. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should also seek medical advice prior to use.

Drug Interactions

Aspirin has been associated with an increased risk of severe gastrointestinal bleeding, particularly when co-administered with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen. This risk is further elevated in patients who are concurrently using anticoagulants or steroid medications.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, 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 of aspirin in the context of their overall medication regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Lil Drug Store Aspirin 325 (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. Healthcare professionals should advise parents to consult a doctor if their child exhibits changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years, it is recommended to consult a doctor for appropriate dosing guidance.

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 profile 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 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 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 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 liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated carefully, as these factors may further complicate the management of therapy in the context of hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, they should avoid use if they have previously experienced an allergic reaction to this product or any of its ingredients.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may include vomiting blood, feeling faint, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical attention if they experience an allergic reaction, if their pain worsens or lasts longer than 10 days, if they notice redness or swelling, if their fever worsens or lasts more than 3 days, or if new symptoms arise. Furthermore, patients should be made aware that they should seek medical help if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also be advised to seek medical guidance prior to use. Additionally, patients should be encouraged to consult a doctor before use if the warning regarding stomach bleeding applies to them, if they are taking a diuretic, or if they are on prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied with an expiration date clearly indicated on the package. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy 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 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 Lil Drug Store Aspirin 325, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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