Alka-Seltzer Plus Maximum Strength Night 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 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, 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 4000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions 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.

Healthcare providers should be vigilant regarding patients presenting with severe sore throat symptoms. If a sore throat 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 instructed to contact a Poison Control Center or seek emergency medical help, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare professional 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; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage may occur if patients exceed 4000 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.

Allergic reactions to acetaminophen can be severe and may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or 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 of a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt medical consultation.

Common adverse reactions may include worsening pain, cough, or nasal congestion lasting more than seven days, fever that worsens or lasts more than three days, and the presence of redness or swelling. New symptoms or a recurrence of cough accompanied by rash or headache that persists should also prompt a consultation with a healthcare provider, as these may indicate a serious condition. Additionally, symptoms such as nervousness, dizziness, or sleeplessness may occur.

Patients with pre-existing conditions should consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, or breathing problems such as emphysema or chronic bronchitis. Those experiencing difficulty in urination due to prostate gland enlargement or a persistent cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers 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 are no known 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 Night Cold and Flu (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 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 to ensure adherence to the recommended 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.

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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4000 mg within a 24-hour period. This threshold is critical, as exceeding it significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to seek emergency medical assistance immediately if an acetaminophen overdose is suspected. Prompt intervention is essential to mitigate potential complications and to initiate appropriate management strategies.

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 allergic reactions characterized by skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. Additionally, marked drowsiness has been noted. Other reported events include nervousness, dizziness, and sleeplessness.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, it is crucial 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 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 an MAOI within the past 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, or if their fever worsens or lasts more than 3 days. They should also seek medical advice if they notice any redness or swelling, experience new symptoms, or if a cough returns or occurs alongside 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. Additionally, patients should seek advice from a doctor or pharmacist 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, 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 Night Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)