Alka-Seltzer Plus Maximum Strength Day Cold and Flu

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, cough, sore throat, and nasal and sinus congestion. 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 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

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. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause severe skin reactions or allergic responses. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, or shock. In the event of a 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 healthcare provider promptly.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists for more than three days; the presence of redness or swelling; the emergence of new symptoms; 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.

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. 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 if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, as these may require prompt medical consultation.

It is recommended that patients 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. These symptoms could indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or breathing problems (e.g., emphysema or chronic bronchitis) should consult a doctor before using this product. Those with difficulty urinating due to prostate gland enlargement or persistent coughs associated with smoking, asthma, or emphysema should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Maximum Strength Day Cold and Flu (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 in this age group to adhere to the specified dosage limits.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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 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 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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 beverages daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening conditions.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's clinical status and consider the need for laboratory tests to evaluate liver function. Prompt intervention may include the administration of N-acetylcysteine (NAC), which is an effective antidote for acetaminophen toxicity, particularly when given within 8 to 10 hours of ingestion.

Monitoring and supportive care should be initiated as necessary, with particular attention to liver function tests and the management of any complications that may arise from the overdosage.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed reports of severe allergic reactions, including anaphylaxis, skin reactions, and other hypersensitivity reactions. Additionally, cases of liver injury have been reported in patients taking acetaminophen, particularly among those who exceeded the recommended dosage or used multiple products containing acetaminophen. There have also been reports of gastrointestinal bleeding associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with acetaminophen.

Some patients have experienced dizziness, nervousness, and sleeplessness while using this product. Furthermore, serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with the use of acetaminophen.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is critical 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.

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 longer than three days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant and consult a doctor if a cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should discontinue use and seek medical advice.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise patients to consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, 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 taking the blood-thinning medication warfarin should be encouraged to consult 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 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 Day Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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