Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and ...

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 nasal congestion, sinus congestion and pressure, headache, minor aches and pains, cough, and sore throat. Additionally, this drug aids in clearing nasal passages and reducing swollen membranes, while also providing 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 over are instructed to take 2 capsules with water every 4 hours as needed. The maximum dosage should not exceed 10 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

Use is not recommended for children under 12 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

• In individuals with a history of allergic reactions to this product or any of its ingredients, to prevent potential anaphylactic reactions.

• In children under 12 years of age, due to safety concerns and lack of efficacy data 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.

Allergy Alert Acetaminophen may lead to 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 a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General Precautions Patients should be cautioned against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients with a history of allergic reactions to this product or any of its components should also refrain from use. This product is contraindicated in children under 12 years of age.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers 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.

When to Stop Taking the Product Patients should discontinue use and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. Additionally, if nervousness, dizziness, or sleeplessness occurs, medical advice should be sought. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

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.

Additionally, acetaminophen may cause severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. If any signs of a skin or general allergic reaction occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation.

Patients are advised to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough returns or occurs with a rash or headache that persists. The emergence of nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to an increased risk of bleeding due to a potential interaction with acetaminophen.

In addition, the use of this product, which contains doxylamine succinate, in conjunction with alcohol, sedatives, or tranquilizers may enhance drowsiness. Caution is advised when engaging in activities that require alertness, and monitoring for increased sedation is recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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. For adolescents aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours, with a maximum of 10 capsules in a 24-hour period, unless otherwise directed by a healthcare professional. Caution is advised to ensure adherence to the recommended dosing guidelines.

Geriatric Use

Elderly patients may require careful consideration when using this medication, as no specific geriatric use information is provided in the prescribing insert. It is advisable for geriatric patients to consult a healthcare provider prior to use, particularly if they have underlying health conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement.

This medication has the potential to cause marked drowsiness; therefore, elderly patients should be cautioned against the consumption of alcoholic beverages, as well as the use of sedatives and tranquilizers, which may exacerbate drowsiness. Additionally, caution is advised when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

The recommended dosage for adults and children aged 12 years and older is 2 capsules every 4 hours, with a maximum limit of 10 capsules within a 24-hour period. While no specific dosage adjustments are indicated for elderly patients, healthcare providers should monitor for any adverse effects and consider individual patient factors when determining the appropriateness of this medication.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this patient population.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg within a 24-hour period. This threshold is critical, as exceeding it significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to seek emergency medical assistance immediately if an acetaminophen overdose is suspected. Prompt intervention is essential to mitigate potential complications and to initiate appropriate management strategies.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Acetaminophen has been associated with severe skin and allergic reactions. 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. Additionally, acetaminophen may induce marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, and tranquilizers. There is also a potential for excitability, particularly in children.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions and severe allergic reactions. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In cases of skin or general allergic reactions, it is advised to discontinue use and seek immediate medical assistance.

Additionally, it is recommended to stop use and consult a healthcare professional if any of the following occur: worsening or persistent pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting for an extended period; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious condition requiring medical evaluation.

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 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 past 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. It is also essential to encourage patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be advised to 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 40ºC (104ºF). 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 Maximum Strength Severe Sinus Congestion and Cough Day and Night, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)