Alka-Seltzer Plus Night Severe Cold and Flu

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 flu, including headache, minor aches and pains, cough, sore throat, nasal congestion, sinus congestion and pressure, runny nose, and sneezing. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. The standard dosing for adults and children aged 12 years and older is to dissolve the contents of one packet in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes.

Dosing may be repeated every 4 hours as needed, but patients must not exceed 5 packets within a 24-hour period unless directed otherwise by a healthcare provider. It is important to note that this product is not intended 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. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

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

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

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 5 packets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product. Healthcare professionals should advise patients to adhere strictly to the recommended dosage and to be vigilant about potential interactions.

In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly. It is imperative to avoid using this product to sedate children, as it is not indicated for pediatric use.

General precautions must be observed. Patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should seek guidance from a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should be advised to confirm with their healthcare provider or pharmacist if they are unsure about the presence of an MAOI in their current prescriptions.

Individuals with a history of allergic reactions to this product or any of its components should refrain from use. Furthermore, this product is contraindicated in children under 12 years of age.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting for an extended period; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 5 packets within a 24-hour period, take the product in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting. This product is not recommended for use in children under 12 years of age and should not be used to sedate children.

Patients are cautioned against using this product if they are currently taking any other drug containing acetaminophen, if they are on a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after discontinuing an MAOI. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, 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. Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should also seek advice from a healthcare professional prior to use.

While using this product, patients must not exceed the recommended dosage, as it may cause marked drowsiness. Alcoholic beverages, sedatives, and tranquilizers may enhance drowsiness, and caution is advised when driving or operating machinery. Excitability may occur, particularly in children.

Patients should discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider.

In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 Night Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be administered this medication for sedation purposes. The use of this medication is contraindicated in children under 12 years of age. Healthcare professionals are advised to consult a physician prior to use in pediatric patients with underlying conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues, including chronic bronchitis or emphysema.

Excitability may occur in pediatric patients, necessitating caution. It is imperative to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face particular safety concerns when using this product. However, it is important to note that the product has the potential to cause marked drowsiness, which may be more pronounced in geriatric patients who are often more sensitive to side effects.

Due to the risk of drowsiness, elderly patients should exercise caution when driving a motor vehicle or operating machinery. It is also advisable for these patients to consult a healthcare provider prior to use, especially if they have any underlying health conditions, although specific conditions are not detailed in the context of geriatric use. Monitoring for side effects and overall tolerance is recommended to ensure safe use in 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 maximum daily amount of 5 packets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with their condition. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and angioedema. Severe skin reactions have also been noted, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Additionally, cases of liver injury, including acute liver failure, have been reported. Gastrointestinal bleeding and renal impairment, including acute kidney injury, have also been observed. Furthermore, cardiovascular events, such as hypertension and arrhythmias, have been documented in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients 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 instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that the medication may cause marked drowsiness, and they should be cautioned against consuming alcoholic drinks while taking it. Additionally, patients should be made aware that the combination of alcohol, sedatives, and tranquilizers can further increase drowsiness.

Healthcare providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Lastly, patients should be informed that excitability may occur, particularly in children, and they should monitor for any unusual behavior.

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 to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours, not to exceed 5 packets within a 24-hour period unless directed by a healthcare professional. For adults and children aged 12 years and older, the contents of one packet should be dissolved in 8 oz. of hot water and consumed within 10-15 minutes while still hot. The use of this medication is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or a Poison Control Center contacted, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Night Severe Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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