Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain Powerfast Fizz

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 or influenza. These symptoms include minor aches and pains, headache, cough, sore throat, runny nose, sneezing, nasal congestion, and sinus congestion. Additionally, this drug 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 fully dissolved in 4 ounces of water every 4 hours. The total daily dosage must not exceed 10 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended.

The tablets should be administered orally, ensuring they are fully dissolved in the specified amount of water prior to consumption.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If uncertain about the presence of an MAOI in a prescription, consult a healthcare professional.

• History of allergic reaction to this product or any of its components, as this may result in severe allergic responses.

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly. Additionally, this product should not be used to sedate children.

Healthcare professionals should recommend that patients consult with a doctor or pharmacist prior to use if they are currently taking the anticoagulant warfarin or any sedatives or tranquilizers, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients should also be advised to discontinue use and consult a physician if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or lasting more than three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

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

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

While using this product, patients may experience marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Caution is advised when driving a motor vehicle or operating machinery. Additionally, excitability may occur, particularly in children.

Patients should discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or persists for more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts. These symptoms could indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

Drug Interactions

Acetaminophen has the potential to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both medications concurrently to ensure safe therapeutic levels.

Concomitant use of chlorpheniramine maleate with alcohol, sedatives, or tranquilizers may lead to increased sedation and drowsiness. Caution is advised when these substances are used together, and patients should be monitored for enhanced sedative effects to mitigate the risk of excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain Powerfast Fizz (chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is contraindicated for sedation in children. Healthcare professionals are advised to consult with a doctor or pharmacist prior to use if the pediatric patient is concurrently taking blood thinners such as warfarin, sedatives, or tranquilizers. Additionally, it is important to note that excitability may occur, particularly in children.

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 therapeutic response, 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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Therefore, dosage adjustments may be necessary for patients with compromised liver function to prevent potential toxicity.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further increase the risk of severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an elevated risk for liver damage while using this product. It is recommended that these patients either avoid alcohol consumption or consult with a healthcare professional for appropriate guidance regarding the use of this product. Regular monitoring of liver function may be warranted in these cases to ensure patient safety.

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 noticeable signs or symptoms.

Potential Symptoms and Risks An overdose of acetaminophen can lead to severe liver damage, particularly when the dosage exceeds 4,000 mg within a 24-hour period. Healthcare professionals should be vigilant in monitoring for signs of liver impairment, which may not manifest until several hours after ingestion.

Management Procedures Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols. This includes assessing the patient's clinical status and considering the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Additionally, the use of N-acetylcysteine (NAC) as an antidote should be evaluated based on the timing and amount of acetaminophen ingested, as it is most effective when administered early in the course of treatment. Continuous monitoring of liver function tests is recommended to evaluate the extent of any potential damage.

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 identified several adverse reactions associated with the use of this product. Severe skin reactions have been reported, including skin reddening, blisters, rash, hives, and facial swelling. Additionally, allergic reactions such as asthma (wheezing) and shock have been documented. Reports of nervousness, dizziness, and sleeplessness have also been associated with the use of this product. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial 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.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, this product is not recommended for children under 12 years of age.

Patients should be instructed to stop using the product and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. They should also seek medical advice if a fever worsens or lasts longer than three 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 headache that lasts, as these may indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should discontinue use and consult a healthcare professional.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and caution patients that the product may cause marked drowsiness. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. They should also be warned to exercise caution when driving or operating machinery.

Finally, patients should be encouraged to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned 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 handling should be observed to prevent any potential degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain Powerfast Fizz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)