Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels

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. Specifically, it alleviates minor aches and pains, headache, nasal congestion, sinus congestion and pressure, cough, sore throat, runny nose, and sneezing. 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.

The use of this medication 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

Severe liver damage may occur with the use of this product, which contains acetaminophen, 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 drinks daily while using this product.

Acetaminophen may also cause 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 promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, this product should not be used to sedate children.

General precautions must be observed. Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist. The product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have taken an MAOI within the past two weeks. Patients should also refrain from using this product if they have a history of allergic reactions to it or any of its ingredients, and it is not recommended for children under 12 years of age.

In cases of overdose, immediate medical attention is crucial. Patients should seek emergency medical help or contact a Poison Control Center without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to stop taking the product 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; cough recurs or is accompanied by a rash or headache that lasts; or if nervousness, dizziness, or sleeplessness occurs. These symptoms may indicate a serious condition requiring medical 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 of these symptoms 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 they should consult a doctor promptly.

It is important to note that this product should not be used to sedate children.

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 occur; or if a cough returns or occurs with a rash or headache that lasts. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

Before using this product, patients with certain medical conditions should consult a doctor. These conditions include liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, and difficulty urinating due to prostate enlargement.

Patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should also consult a doctor or pharmacist prior to use.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily. It is advisable for patients to avoid combining these substances to mitigate the risk of hepatotoxicity.

Chlorpheniramine may induce significant drowsiness; therefore, it is recommended to avoid the concomitant use of alcohol, sedatives, and tranquilizers, as these can exacerbate drowsiness and impair cognitive and motor functions.

Dextromethorphan is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing MAOIs, as this combination may lead to serious adverse effects. Patients should be advised to refrain from using dextromethorphan in these circumstances.

Patients on warfarin should seek medical advice prior to using this product, as there may be interactions that could affect International Normalized Ratio (INR) levels, necessitating careful monitoring and potential dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, 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 dosing guidelines to prevent potential overdose.

Geriatric Use

Elderly patients may be at an increased risk for adverse effects when using this medication, as no specific geriatric use information is provided in the prescribing information. It is important to note that this medication may cause marked drowsiness, and the concomitant use of alcohol, sedatives, or tranquilizers may further enhance this effect. Therefore, caution is advised when driving a motor vehicle or operating machinery.

Healthcare providers should recommend that elderly patients consult a physician prior to use if they have any of 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 gland enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

While there are no specific dosage adjustments or age considerations mentioned for geriatric patients, careful monitoring for potential side effects is warranted in this population due to their increased sensitivity to medications.

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

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

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

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe skin reactions such as skin reddening, blisters, rash, and hives. Additionally, allergic reactions have been noted, which may manifest as facial swelling, asthma (wheezing), and shock. Reports of marked drowsiness have also been documented. Furthermore, excitability has been observed, particularly in pediatric populations.

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 instructed 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.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or within two weeks of stopping an MAOI. Patients should be encouraged to ask their healthcare provider 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 more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant if a cough returns 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.

When using this product, patients must not exceed the recommended dosage. They should be made aware that the medication may cause significant drowsiness and should avoid alcoholic beverages while taking it. Patients should also be cautioned that alcohol, sedatives, and tranquilizers may enhance drowsiness. Care should be taken when driving or operating machinery due to the potential for drowsiness. Additionally, patients should be informed that excitability may occur, particularly in children.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or persistent coughs associated with smoking, asthma, or emphysema should consult a doctor before using this product.

Lastly, 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 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 Cold and Cough Liquid Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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