Alka-Seltzer Original Flavor

Description

Alka-Seltzer® is an effervescent formulation containing buffered aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. This product is designed to provide fast relief from various types of discomfort, including headache, backache, body aches, and muscle pain. The tablets are presented in an original flavor and are packaged in pouches containing two tablets each, with a total of three pouches per package.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscle pain, backache, toothache, menstrual pain, colds, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is to fully dissolve 2 tablets in 4 ounces of water prior to administration. The dosing frequency is every 4 hours, or as directed by a healthcare professional. It is important not to exceed 8 tablets within a 24-hour period.

For adults aged 60 years and older, the same dosing instructions apply: 2 tablets every 4 hours, or as directed by a healthcare professional, with a maximum limit of 8 tablets in a 24-hour timeframe.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it 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 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.

Before initiating treatment, it is advisable for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, asthma, or adherence to a sodium-restricted diet. Additionally, patients should seek guidance from a healthcare professional or pharmacist if they are currently taking prescription 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 are advised to discontinue use and contact a 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 10 days, fever lasting more than 3 days, presence of redness or swelling, emergence of new symptoms, or experiencing ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Reye's syndrome is a rare but serious illness that may 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 could 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, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should stop use and seek medical help right away.

This 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 take more than the recommended dosage or for an extended period.

Patients should discontinue use 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 stomach pain that does not improve. Additional symptoms warranting medical attention include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

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, or kidney disease, are taking diuretics, have asthma, or are on a sodium-restricted diet.

For pregnant or breastfeeding patients, it is essential to seek advice from a health professional before use. Aspirin should particularly be avoided after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product raises concerns regarding potential drug interactions, particularly with anticoagulants and corticosteroids. The concomitant use of this NSAID with blood thinners (anticoagulants) or steroid medications may significantly increase the risk of severe gastrointestinal bleeding.

Healthcare professionals are advised to closely monitor patients who are prescribed this NSAID alongside anticoagulants or corticosteroids for any signs of gastrointestinal distress or bleeding.

Additionally, it is recommended that patients consult with their healthcare provider or pharmacist prior to using this product if they are currently taking prescription medications for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use, as these conditions may influence the pharmacological effects and safety profile of the NSAID.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Original Flavor (buffered aspirin, effervescent tablet). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chickenpox 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 over are directed to take 2 tablets every 4 hours, not to exceed 8 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

For adults aged 60 years and over, the recommended dosage is 2 tablets every 4 hours, or as directed by a healthcare provider. It is crucial that this population does not exceed a total of 8 tablets within a 24-hour period to minimize the risk of adverse effects.

Healthcare providers should closely monitor geriatric patients for any signs of gastrointestinal bleeding and consider individual patient factors when determining the appropriateness of therapy. Adjustments to dosage or alternative treatment options may be warranted based on the patient's overall health status and concurrent medications.

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 outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 pregnancy 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 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 or treatment regimens may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the course of therapy.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been reported, particularly among individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning medications, or those consuming three or more alcoholic drinks daily while using this product.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. They should also refrain from using it if they have previously experienced an allergic reaction to this product or any of its ingredients. In case of an allergic reaction, patients should stop using the medication and seek medical assistance right away.

Healthcare providers should counsel patients to discontinue use 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 stomach pain that does not improve. Patients should also be advised to seek medical attention if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if they experience ringing in the ears or a loss of hearing.

It is important for 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 encouraged to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Patients taking diuretics, those with asthma, or individuals on a sodium-restricted diet should also seek medical advice before using this product. Furthermore, patients should consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis to ensure safe use of this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should fully dissolve 2 tablets in 4 ounces of water prior to administration. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, not to exceed 8 tablets in a 24-hour period. Adults aged 60 years and older should follow the same dosing guidelines. For children under 12 years, consultation with a doctor is advised.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed 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 Alka-Seltzer Original Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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