Alka Seltzer Plus Maximum Strength Sinus, Allergy and Cough Power Max 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 hay fever or other upper respiratory allergies, including runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes. Additionally, it is indicated for the temporary relief of symptoms due to the common cold, such as minor aches and pains, headache, cough, sore throat, nasal congestion, and sinus congestion and pressure. This drug also 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:

• Co-administration with any other drug containing acetaminophen (prescription or nonprescription) is prohibited due to the risk of acetaminophen overdose.

• The product should not be used 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.

• Individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use to prevent adverse reactions.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke 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 any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that 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 must be observed. Patients should not use 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, patients should be encouraged to consult a healthcare professional. 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 should be reminded to inquire with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

This product is contraindicated in individuals with a known history of allergic reactions to acetaminophen or any of its components. Furthermore, it is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and contact their 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; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to 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 signs or symptoms.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic responses.

Severe liver damage may occur if patients 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.

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

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended to consult a healthcare professional promptly.

Common adverse reactions may necessitate discontinuation of use and consultation with a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs with a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt patients to seek medical advice.

Patients with pre-existing conditions should consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough associated with excessive phlegm, or difficulty urinating due to prostate enlargement. Furthermore, individuals taking blood-thinning medications such as warfarin or those using sedatives or tranquilizers should seek guidance from a healthcare professional prior to using this product.

Drug Interactions

Acetaminophen has the potential to enhance the anticoagulant effects of warfarin, which may result in an increased risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently.

Concomitant use of alcohol, sedatives, and tranquilizers with this product may lead to increased drowsiness. Patients are advised to exercise caution when driving or operating machinery while using these substances together.

Packaging & NDC

Below are the non-prescription pack sizes of Alka Seltzer Plus Maximum Strength Sinus, Allergy and Cough Power Max Gels (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 dosing guidelines to prevent potential overdose.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for efficacy and adverse effects is recommended in this demographic, given the potential for increased sensitivity to medications in older adults.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available 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 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 individuals with reduced kidney function, as the lack of information 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 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, significant health risks are associated with excessive intake.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative toxicity.

Additionally, the consumption of three or more alcoholic beverages daily while using acetaminophen significantly increases the likelihood of severe liver damage.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's liver function and consider the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdose is identified within a critical time frame. Continuous monitoring of liver enzymes and overall patient status is crucial for effective management and intervention.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to 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, hives, and facial swelling. Additionally, allergic reactions have been noted, which may manifest as asthma (wheezing) and shock. Reports of nervousness, dizziness, and sleeplessness have also been documented.

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.

It is important to instruct patients not to use this product 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 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 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 a motor vehicle 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, a cough that produces excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema) should consult a doctor before using this product. Furthermore, 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. Temperatures should not exceed 40ºC (104ºF) to maintain product integrity. Proper storage conditions are crucial for preserving the efficacy and safety 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 Sinus, Allergy and Cough Power Max Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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