Alka-Seltzer Plus Severe Cold and Flu Powerfast Fizz

Description

No description information is available for the 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, and nasal and sinus congestion. Additionally, this drug temporarily reduces fever.

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 maximum dosage should not exceed 8 tablets within a 24-hour period unless otherwise 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 reaction to this product or any of its ingredients, which 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 physician 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., due to smoking, asthma, or emphysema), or those on a sodium-restricted diet. Additionally, patients should consult a healthcare provider or pharmacist prior to use if they are taking warfarin, sedatives, or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should 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 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 persisting beyond 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 further 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 of such reactions 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 of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, patients may experience marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. 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 observed; if new symptoms arise; if cough recurs or is accompanied by a rash or headache that lasts; or if nervousness, dizziness, or sleeplessness occurs.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 be administered this medication. It is contraindicated for use in children for sedation purposes. Caution is advised as excitability may occur, particularly in pediatric populations.

Geriatric Use

Elderly patients may be at an increased risk for adverse effects when using this product, as no specific geriatric use information is provided in the prescribing information. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Before initiating treatment, it is advisable to assess the patient's medical history, especially for conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or urinary difficulties due to prostate enlargement. These conditions may exacerbate the potential risks associated with the medication.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this product may heighten drowsiness, a significant concern for elderly patients who may already be more sensitive to the sedative effects of medications. The potential for marked drowsiness necessitates careful monitoring of geriatric patients to mitigate the risk of falls or other complications related to impaired alertness.

Healthcare providers should consider these factors and monitor elderly patients closely for any adverse reactions or the need for dosage adjustments.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use. During treatment, patients are advised to avoid alcoholic beverages to minimize the risk of liver damage.

Patients should discontinue use and seek medical advice if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; the presence of redness or swelling; the emergence of new symptoms; or if a cough recurs or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

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 needed.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Acetaminophen has been associated with the potential for severe skin or allergic reactions. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified reports of severe allergic reactions, including anaphylaxis, skin reactions, and liver injury associated with the use of this product. Notably, cases of severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Additionally, there have been reports of elevated liver enzymes and instances of acute liver failure in patients using acetaminophen-containing products, including this product, particularly among those who exceed the recommended dosage or consume alcohol concurrently.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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 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 last two weeks. 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 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 be advised to 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 medication 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, as excitability may occur, particularly in children.

Patients with 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, persistent or chronic cough (such as that associated with smoking), asthma, or those on a sodium-restricted diet should consult a doctor before using this product. Additionally, patients taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should seek advice from a doctor or pharmacist prior to use.

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

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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