Alka-Seltzer Plus Maximum Strength Night Cold and Flu Powermax 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. These symptoms include minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, and sneezing. Additionally, this drug temporarily reduces 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 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, as safety and efficacy have not been established 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 4000 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 lead to 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.

It is crucial to keep this product out of reach of children. In cases of overdose, immediate medical help should be sought, or a Poison Control Center should be contacted. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or lasts more than 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 that persists. These may indicate a serious condition. Furthermore, if nervousness, dizziness, or sleeplessness occurs, patients should also discontinue use and seek medical advice.

Side Effects

Severe liver damage may occur in patients who exceed 4000 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.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. 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, patients are advised 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 consult a healthcare professional promptly.

Patients are also advised to stop use and consult 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 present; if new symptoms develop; if cough recurs or occurs with a rash or headache that persists; or if nervousness, dizziness, or sleeplessness occurs.

It is recommended that patients consult a doctor before use if they have a history of 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 persistent or chronic cough associated with smoking, asthma, or emphysema.

Additionally, patients should seek advice from a doctor or pharmacist prior to use if they are taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

Drug Interactions

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

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. Therefore, it is recommended that dextromethorphan not be used in patients currently taking MAOIs or within two weeks of discontinuing MAOI therapy to prevent potential complications.

Patients on warfarin should seek medical advice prior to using acetaminophen, as it may influence International Normalized Ratio (INR) levels and elevate the risk of bleeding. Monitoring of INR levels may be warranted to ensure safe co-administration.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Night Cold and Flu Powermax 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 recommended dosing guidelines.

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. 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 of these patients.

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 4000 mg of acetaminophen within 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 Administration of acetaminophen exceeding 4000 mg within a 24-hour period poses a substantial risk of severe liver damage. Healthcare professionals should be vigilant in assessing the total daily intake of acetaminophen, particularly in patients who may inadvertently exceed this threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar risks of severe liver damage. It is crucial for healthcare providers to review all medications a patient is taking to prevent unintentional overdosing.

Alcohol Consumption Considerations Patients who consume three or more alcoholic beverages daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should counsel patients regarding the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should monitor liver function tests and consider the administration of N-acetylcysteine as an antidote, particularly if the overdose is identified within a critical time frame. Prompt intervention is essential to mitigate the risk of irreversible liver injury.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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, severe 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 present.

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 last 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, if fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise, if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition. Furthermore, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

When using this product, patients must not exceed the recommended dosage. They should be made aware that the medication may cause marked drowsiness and should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving a motor vehicle or operating machinery.

Patients should be informed that excitability may occur, particularly in children. It is advisable for patients to consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Lastly, patients should be encouraged to ask a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

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 temperatures do not exceed 25°C (77°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 Night Cold and Flu Powermax Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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