Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, nasal congestion, sinus congestion and pressure, and for the 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 older are instructed to take 2 capsules orally with water every 4 hours as needed. The total daily dosage must not exceed 10 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

Use of this medication is not recommended for children under 12 years of age. It is essential to adhere to the recommended dosage and not exceed the specified limits to ensure safety and efficacy.

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 carries specific warnings and precautions that healthcare professionals must communicate to patients for safe use.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor the total daily intake of acetaminophen and assess the patient's alcohol consumption to mitigate the risk of liver injury.

Allergy Alert Acetaminophen may induce severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. Should any of these symptoms manifest, the patient must discontinue use immediately and seek medical assistance. Healthcare professionals should remain vigilant for signs of allergic reactions, particularly in patients with a history of drug allergies.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative for the patient to consult a physician promptly. This may indicate a more serious underlying condition that requires further evaluation.

General Precautions This product should be kept out of reach of children. In the event of an overdose, immediate medical attention is crucial. Healthcare providers should advise patients to contact a Poison Control Center or seek emergency medical help, regardless of the presence of symptoms, as rapid intervention is critical for both adults and children.

Instructions for Stopping Use and Seeking Medical Advice Patients should be instructed to stop taking this 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 lasts, as these may indicate a serious condition.

• Symptoms of nervousness, dizziness, or sleeplessness arise.

Healthcare professionals should ensure that patients are fully informed of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include significant liver damage, which 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, patients may experience severe skin or allergic reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms indicating a need for medical consultation. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly. Furthermore, patients are advised to stop use and seek medical advice if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Lastly, patients should be aware that the occurrence of nervousness, dizziness, or sleeplessness may also warrant consultation with a healthcare professional.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding due to potential pharmacodynamic interactions. Monitoring of coagulation parameters is advisable in such cases to ensure patient safety.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels (acetaminophen, 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 not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 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 exercise caution when using this product, which contains acetaminophen. 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 concomitant use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

It is also important for patients with compromised liver function 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 severe liver damage.

Monitoring of liver function is advised in patients with hepatic impairment who are prescribed this product, and healthcare providers should consider alternative therapies that may pose a lower risk to liver health.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

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 dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic drinks daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening liver injury.

Recommended Actions In the event of suspected overdosage, it is imperative for healthcare professionals to assess the patient's condition promptly. Immediate medical intervention is recommended, and the patient should be monitored for symptoms of liver damage. Supportive care and specific treatments, such as the administration of N-acetylcysteine, may be necessary depending on the severity of the overdose and the time elapsed since ingestion.

Healthcare providers should ensure that patients are educated about the risks associated with acetaminophen overdosage, including the importance of adhering to recommended dosages and being cautious of concurrent use with other acetaminophen-containing products or alcohol.

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, 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, 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 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) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. 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.

Healthcare providers should counsel patients to discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or persists for more than seven days. They should also be instructed to seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should stop using the product and consult a healthcare professional.

Patients must be reminded not to exceed the recommended dosage while using this product. It is advisable for patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough related to smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to seek advice 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 should be stored at room temperature, ensuring that the storage environment does not exceed temperatures of 40ºC (104ºF) to maintain product integrity. Care should be taken to avoid exposure to excessive heat during storage and handling.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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