Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu

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. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, it 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 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.

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. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

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

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

• Use in children under 12 years of age is contraindicated due to safety concerns.

Additionally, it is essential not to exceed the recommended dosage when using this product to avoid potential adverse effects.

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 contain acetaminophen concurrently, 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, asthma (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, particularly if it 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.

General precautions include the following: patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of an MAOI. Additionally, this product should not be used by individuals with a known allergy to acetaminophen or any of its components, nor should it be administered to children under 12 years of age.

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 the presence of symptoms.

Patients should also be advised to stop using the product and consult a healthcare provider 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; cough recurs or is accompanied by a rash or headache that persists; or if nervousness, dizziness, or sleeplessness occurs.

Side Effects

Patients using this product should be aware of several important warnings regarding 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 lead to severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Furthermore, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Drug Interactions

Patients taking the blood-thinning medication warfarin should consult a healthcare professional prior to using Alka-Seltzer Plus products containing acetaminophen. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

Currently, there are no additional drug interactions or laboratory test interactions reported for Alka-Seltzer Plus products. Therefore, routine monitoring or dosage adjustments are not indicated beyond the specific caution regarding warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu (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 should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or conditions such as cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, or emphysema.

Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are currently taking the anticoagulant medication warfarin, as interactions may occur.

Elderly patients are advised to adhere strictly to the recommended dosage and should not exceed this amount. Quick medical attention is essential for all adults, including elderly patients, even in the absence of noticeable signs or symptoms. Monitoring for any adverse effects or complications is crucial in this population.

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 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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

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. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

Acetaminophen overdose can lead to severe liver damage, particularly when the total daily intake exceeds 4,000 mg. Healthcare professionals should be vigilant in monitoring patients for signs of overdose, especially in those who may inadvertently exceed this threshold.

It is critical to advise patients against the concurrent use of any other medications containing acetaminophen. This precaution is essential to mitigate the risk of overdose, as combining multiple acetaminophen-containing products can easily lead to unintentional excessive dosing.

In the event of suspected overdosage, immediate medical evaluation is warranted. Symptoms of acetaminophen overdose may not be immediately apparent, but can progress to include nausea, vomiting, loss of appetite, confusion, and jaundice. Prompt recognition and management are vital to prevent irreversible liver damage.

Healthcare providers should follow established protocols for the management of acetaminophen overdose, which may include the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdose is identified within a critical time frame. Continuous monitoring of liver function tests and supportive care are also recommended to ensure patient safety and recovery.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included severe skin reactions, such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, allergic reactions have been noted, which may manifest as asthma (wheezing) and shock.

In the event of a skin or general allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

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 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 initially 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 medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken 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 medication is not recommended for children under 12 years of age.

While using this product, patients must not exceed the recommended dosage. They should be instructed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or persists for more than 7 days, or if fever worsens or lasts more than 3 days. Patients 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.

Patients should be made aware that if they experience nervousness, dizziness, or sleeplessness, they should discontinue use and consult a healthcare professional. Furthermore, patients should be advised to seek medical guidance before using this product 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 encouraged to consult their 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 Maximum Strength Day and Night Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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