Ascurin Fast Action

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for the reduction of fever.

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

Dosage and Administration

Patients are advised to 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 5 to 8 sachets every 4 hours. The total daily intake should not exceed 49 sachets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is essential to consult a doctor prior to administration to determine the appropriate dosage.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used for at least 7 days following tonsillectomy or oral surgery unless directed by a healthcare professional.

Patients should discontinue use and seek medical attention if any signs of an allergic reaction occur. Immediate medical help is also necessary if symptoms indicative of stomach bleeding arise, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Furthermore, if fever worsens or persists beyond 3 days, or if redness, swelling, new symptoms, or auditory disturbances such as ringing in the ears or loss of hearing occur, medical advice should be sought.

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 Reye's syndrome, a rare but serious condition.

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 meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients taking anticoagulants or steroid medications, those using other NSAIDs (including aspirin, ibuprofen, or naproxen), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to seek medical guidance prior to using this product if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should consult a physician before use. It is also recommended that patients discuss the use of this product with their healthcare provider or pharmacist if they are currently prescribed medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than ten days, fever that worsens or lasts more than three days, presence of redness or swelling, occurrence of any new symptoms, or experiencing ringing in the ears or loss of hearing.

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 may be early signs of Reye's syndrome.

Aspirin, the active ingredient in this product, may also 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 help right away.

Additionally, 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen. Patients should 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 persistent stomach pain.

Patients are advised to seek medical advice before using this product 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. It is also recommended that patients consult a doctor if they are taking diuretics or have asthma. Furthermore, patients should inform their healthcare provider if they are taking prescription medications for diabetes, gout, or arthritis prior to using this product.

In summary, patients should be vigilant for serious adverse reactions and consult healthcare professionals as necessary to ensure safe use of this product.

Drug Interactions

Co-administration of aspirin with anticoagulant medications may elevate the risk of significant gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these agents are used concurrently.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, may also heighten the risk of severe stomach bleeding. It is advisable for healthcare providers to assess the necessity of aspirin therapy in patients already receiving NSAIDs and to monitor for gastrointestinal complications.

Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating aspirin therapy to ensure safe and effective use. No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Ascurin Fast Action (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 essential to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

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 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 healthcare provider.

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 doctor, 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 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 and effective 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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

No postmarketing experience details are available in the insert.

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 medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be cautioned against using this medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They must be instructed to discontinue use and consult a doctor if any signs of an allergic reaction occur, emphasizing the importance of seeking medical help promptly.

Healthcare providers should educate patients on the signs of potential stomach bleeding, advising them to stop use and contact a doctor if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be informed to seek medical advice if pain worsens or persists for more than 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, if any new symptoms arise, or if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients should be advised to seek medical guidance 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 be encouraged to consult a doctor prior to use.

Finally, healthcare providers should recommend that patients speak with a doctor or pharmacist before using this medication if they are currently taking a prescription drug for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 77°F (25°C). Temporary excursions from this temperature are permissible, provided they remain within the range of 59-86°F (15-30°C). Proper container requirements must be adhered to, and special handling considerations should be observed to maintain product integrity.

Additional Clinical Information

Patients should be advised to drink a full glass of water with each dose of the medication. For adults and children aged 12 years and older, the recommended dosage is 5-8 sachets every 4 hours, not to exceed 49 sachets in a 24-hour period unless directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is necessary before administration.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, 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 Ascurin Fast Action, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)