Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels

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, nasal and sinus congestion, sinus 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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

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

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

• In children under 12 years of age, due to safety concerns and lack of efficacy data.

Additionally, it is advised to avoid exceeding the recommended dosage and to refrain from consuming alcoholic beverages, as these may exacerbate drowsiness and increase the risk of adverse effects. Caution is also warranted when driving or operating machinery due to the potential for marked drowsiness.

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 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, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with severe 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, prompt consultation with a physician is warranted.

It is imperative to keep this product out of reach of children. In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek medical help without delay, regardless of the presence of symptoms.

Patients should be instructed to stop taking the product and consult a healthcare professional 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 symptoms of nervousness, dizziness, or sleeplessness arise. These may indicate a serious condition requiring further evaluation.

Finally, it is important to note that this product should not be used to sedate children.

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 should discontinue use immediately and seek medical assistance.

Patients are advised to consult a doctor 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.

It is crucial for patients to stop use and consult a healthcare professional 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 arise, or if a cough returns with a rash or headache that persists. These may indicate a serious condition. Patients should also seek medical advice if they experience nervousness, dizziness, or sleeplessness.

Before using this product, patients should inform their healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, or any breathing problems such as emphysema or chronic bronchitis. Additionally, those with difficulty urinating due to prostate gland enlargement or persistent coughs associated with smoking, asthma, or emphysema should also consult a doctor.

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels (acetaminophen, chlorpheniramine malaeate, 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 patients 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 in adherence to the dosing guidelines to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 therapeutic response, given the general considerations 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of acetaminophen. Specifically, the risk of significant hepatic injury increases when the total daily dosage exceeds 4,000 mg within a 24-hour period.

Healthcare professionals should be vigilant in identifying symptoms indicative of acetaminophen overdosage. Patients presenting with signs of overdose should be advised to seek emergency medical assistance immediately. This is particularly important if they exhibit severe symptoms, which may include but are not limited to nausea, vomiting, loss of appetite, confusion, or jaundice.

Management of acetaminophen overdosage typically involves prompt medical evaluation and intervention. Healthcare providers should consider administering activated charcoal if the patient presents within a suitable timeframe post-ingestion, and they should monitor liver function tests closely. In cases of confirmed overdose, the use of N-acetylcysteine (NAC) as an antidote should be initiated as per established protocols to mitigate liver damage and improve patient outcomes.

It is essential for healthcare professionals to remain aware of these guidelines to ensure timely and effective management of acetaminophen overdosage.

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 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, 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 for two weeks after discontinuing an MAOI. Patients should be encouraged to ask a healthcare professional 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 pain, cough, or nasal congestion worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if redness or swelling occurs. They should also seek medical advice if new symptoms arise, if a cough returns or is accompanied by 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 significant drowsiness and should avoid alcoholic beverages while using it. Patients should also be cautioned that alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should exercise caution when driving or operating machinery while using this product, as excitability may occur, particularly in children.

Healthcare providers should recommend that patients consult a doctor before use 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 advised to consult a doctor or pharmacist before using this product 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 it is kept away from excessive heat, specifically temperatures exceeding 25ºC (77ºF). 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 Power Max Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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