Alka-Seltzer Plus Cough and Sore Throat Fizzychews

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, headache, cough, and sore throat. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 tablets every 4 hours as needed. The total daily dosage must not exceed 6 doses (12 tablets) within a 24-hour period, unless otherwise directed by a healthcare professional.

For children aged 6 to under 12 years, the recommended dosage is also 2 tablets every 4 hours. However, the total daily dosage for this age group must not exceed 5 doses (10 tablets) in a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential that the tablets are not swallowed whole. They should be thoroughly chewed or crushed before swallowing to ensure proper administration. The use of this medication is not recommended for children under 6 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. Consultation with a healthcare professional is advised if there is uncertainty regarding MAOI status.

• Individuals with a history of allergic reactions to this product or any of its ingredients should not use it.

• This product is not recommended for use in children under 6 years of age.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if it is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also cause severe skin or allergic reactions. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, or shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have liver disease, a cough with excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or if they are on a sodium-restricted diet. Additionally, it is advisable to consult a doctor or pharmacist before use if the patient is taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or persists beyond 5 days in children or 7 days in adults; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in the same timeframe, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

A warning is also issued for patients experiencing a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting; these individuals should consult a healthcare provider promptly.

In clinical trials and postmarketing experiences, marked drowsiness has been reported among patients using this product. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate this drowsiness, necessitating caution when driving or operating machinery. Additionally, excitability has been noted, particularly in pediatric patients.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or persists beyond 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs alongside a rash or headache that lasts.

Drug Interactions

Patients taking acetaminophen should consult a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The interaction between these two drugs may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of therapy.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Cough and Sore Throat Fizzychews (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 2 tablets every 4 hours, with a maximum of 5 doses (10 tablets) in a 24-hour period, unless otherwise directed by a healthcare professional.

In contrast, adults and children aged 12 years and older may take 2 tablets every 4 hours, not exceeding 6 doses (12 tablets) in 24 hours, unless otherwise directed by a healthcare professional.

Healthcare providers should advise parents and caregivers to discontinue use and consult a doctor if a child's pain or cough worsens or persists for more than 5 days, or if a child's fever worsens or lasts more than 3 days. For adults, if pain or cough lasts longer than 7 days, medical advice should also be sought.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Regular monitoring of liver function may be warranted in these patients to prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, there have been reports of acute liver failure in patients taking acetaminophen, particularly in those with underlying liver disease or those who exceed the recommended dosage. Cases of allergic reactions, including anaphylaxis, have also been reported. Furthermore, gastrointestinal bleeding has been associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with acetaminophen.

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, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

It is important to inform patients that they should not use this product if they have a history of allergic reactions to it or any of its ingredients. Furthermore, this medication is not recommended for children under 6 years of age.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 5 days for children or 7 days for adults. They should also seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant if a cough recurs or is accompanied by a rash or persistent headache.

While using this product, patients must not exceed the recommended dosage. They should be made aware that the medication may cause marked drowsiness and should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is advised when driving or operating machinery.

Patients should be informed that excitability may occur, especially in children. It is advisable for patients to consult a doctor before using this product if they have liver disease, a cough with excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients taking the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist before using this product.

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, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Cough and Sore Throat Fizzychews, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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