Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night

Description

No relevant information is available for SPL code 34089-3.

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, nasal and sinus congestion, and 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.

This medication is not recommended for use in 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.

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

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must 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.

Patients are instructed to stop use and seek medical advice if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting longer than usual; or if they experience nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed 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

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who 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.

Patients may also 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, it is imperative that patients discontinue use and seek immediate medical assistance.

Additionally, a sore throat warning is indicated for patients whose sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting; such patients should consult a healthcare provider promptly.

Patients are 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 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 condition. Other notable adverse reactions include nervousness, dizziness, or sleeplessness.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking the anticoagulant warfarin. The combination may necessitate careful monitoring of coagulation parameters due to potential alterations in anticoagulant effects.

Additionally, caution is advised for patients using sedatives or tranquilizers, as the concomitant use may enhance sedative effects, leading to increased drowsiness. Monitoring for excessive sedation is recommended.

This medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Furthermore, the use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Lastly, the consumption of alcohol alongside this medication, as well as with sedatives and tranquilizers, may significantly increase drowsiness, warranting caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). 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 should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, those experiencing difficulty in urination due to prostate enlargement or persistent cough associated with smoking, asthma, or emphysema should seek medical advice.

It is crucial for geriatric patients to adhere strictly to the recommended dosage, as exceeding this may lead to adverse effects. The product may cause significant drowsiness; therefore, elderly patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which can exacerbate drowsiness. Caution is also recommended when driving or operating machinery due to the potential for impaired alertness.

While excitability is more commonly noted in children, elderly patients should be aware of their overall response to the medication. Furthermore, pregnant or breastfeeding women should consult a healthcare professional before using this product to ensure safety for both mother and child.

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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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, 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. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management.

Prompt recognition and intervention are critical to mitigate the potential consequences of acetaminophen overdosage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. The use of the product may lead to marked drowsiness, and excitability may occur, particularly in children.

No specific nonclinical toxicology information or animal pharmacology and toxicology data is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin and allergic reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, the use of this product may lead to marked drowsiness. Users are cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Care should be taken when driving or operating machinery. Excitability has also been reported, particularly in children.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening or persistent pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting longer than usual; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious condition requiring medical evaluation.

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 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 recurs 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 provider.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, 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 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 is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, specifically 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 Multi-Symptom Cold and Flu Day and Night, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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