Alka-Seltzer Plus Severe Cold and Flu 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 and sinus congestion, and fever reduction.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets fully dissolved in 4 ounces of water every 4 hours as needed. The total dosage should not exceed 8 tablets within a 24-hour period unless directed by a healthcare professional.

This medication is not recommended for use in children under 12 years of age.

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.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

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

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily 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, asthma (wheezing), and 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting.

This product is contraindicated for use as a sedative in children.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, persistent or chronic cough (e.g., smoking, asthma, emphysema), or those on a sodium-restricted diet. Additionally, patients should consult a healthcare provider before use if they are taking blood thinners such as warfarin or sedatives/tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional 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; or if nervousness, dizziness, or sleeplessness develops. These symptoms may indicate a serious underlying condition.

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.

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; such individuals should 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 are advised to 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 with a rash or headache that lasts. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider.

It is important to note that this product should not be used to sedate children. Patients should seek medical advice prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to prostate gland enlargement, a persistent or chronic cough, or are on a sodium-restricted diet. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent. Patients should contact a Poison Control Center without delay.

Drug Interactions

Acetaminophen has the potential to elevate the risk of severe liver damage when used concurrently with other products containing acetaminophen or in individuals consuming three or more alcoholic beverages daily.

Chlorpheniramine maleate is associated with significant drowsiness; therefore, it is advisable to avoid concomitant use with alcohol, sedatives, and tranquilizers, as these substances may enhance the sedative effects.

When warfarin is administered alongside acetaminophen, there is an increased risk of bleeding. It is recommended to monitor the International Normalized Ratio (INR) closely in such cases to ensure safe therapeutic levels.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 tablets fully dissolved in 4 oz of water every 4 hours, with a maximum of 8 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Caution is advised as excitability may occur, particularly in children. This medication is not indicated for use in sedating pediatric patients.

Geriatric Use

Elderly patients may not require specific dosage adjustments or exhibit unique safety concerns when using this product. However, it is important to note that the product has the potential to cause marked drowsiness, which could pose risks for this population.

Due to the possibility of drowsiness, geriatric patients should exercise caution when driving a motor vehicle or operating machinery. It is advisable for elderly patients to consult a healthcare provider prior to use if they have any underlying health conditions, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or difficulty urinating due to prostate gland enlargement. Monitoring and careful consideration of these factors are recommended to ensure the safe use of the product in this demographic.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 should consult a healthcare professional prior to use. Special monitoring may be required for these patients, and dosage adjustments may be necessary based on the degree of reduced renal function. Additionally, renal function tests should be considered for patients with a history of kidney disease to ensure safe and effective use of the medication.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects early.

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.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe allergic reactions, which include skin reddening, blisters, rash, hives, and facial swelling. Additionally, cases of asthma (wheezing) and shock have also been documented.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should 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 present.

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 medication contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes 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 discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days, or if their fever worsens or lasts more than 3 days. They should also seek medical advice if they notice any redness or swelling, experience new symptoms, or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition. Furthermore, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

When using this product, patients must not exceed the recommended dosage. They should be made aware that the product may cause marked drowsiness and should avoid alcoholic beverages while using it. Patients should also be cautioned that alcohol, sedatives, and tranquilizers may enhance drowsiness. Care should be taken when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should be informed that excitability may occur, particularly in children. It is advisable for patients to consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, a persistent cough associated with smoking, asthma, or if they are on a sodium-restricted diet.

Lastly, 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 storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Severe Cold and Flu Powerfast Fizz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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