Nighttime Cold and Flu Max Softgels Maximum Strength

Description

TopCare Health Nighttime Cold & Flu Max Softgels are formulated as maximum strength liquid-filled capsules, containing a combination of active ingredients designed to relieve symptoms associated with cold and flu. Each softgel includes acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant. The product is packaged in a bottle containing 24 softgels. The National Drug Code (NDC) for this formulation is 36800-732-24, and it is comparable to Alka-Seltzer® Plus® Maximum Strength Nighttime Cold & Flu PowerMax™ Gels.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, sore throat, nasal and sinus congestion, and for the temporary reduction of 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 softgels with water every 4 hours as needed. The maximum dosage should not exceed 10 softgels 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.

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, as safety and efficacy have not been established in this population.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that liver damage may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

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

General precautions should be emphasized. This product should not be used to sedate children. Patients should be encouraged to consult a healthcare provider prior to use if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

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

Patients should be advised to 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 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 expected; or if they experience nervousness, dizziness, or sleeplessness. Pregnant or breastfeeding individuals should consult a healthcare professional before use.

Side Effects

Severe liver damage may occur 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 should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

While using this product, patients may experience marked drowsiness; therefore, it is advisable to avoid alcoholic beverages. The concomitant use of alcohol, sedatives, and tranquilizers may further enhance drowsiness. Caution is recommended when driving or operating machinery. Additionally, excitability may occur, particularly in children.

Patients are advised to stop use and consult a healthcare professional if pain, cough, or nasal congestion worsens or persists beyond 7 days, if fever worsens or lasts more than 3 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 could indicate a serious condition. Furthermore, if nervousness, dizziness, or sleeplessness occurs, patients should seek medical advice.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Max Softgels Maximum Strength (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 adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels 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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. 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 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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals to prevent potential adverse effects associated with acetaminophen use.

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 noticeable signs or symptoms.

Potential Symptoms and Risks Overdosing on acetaminophen can lead to severe liver damage, particularly if the intake exceeds 4,000 mg within a 24-hour period. This risk is heightened when acetaminophen is taken in conjunction with other medications containing the same active ingredient or when the individual consumes three or more alcoholic beverages daily while using this product.

Management Procedures Healthcare professionals should be prepared to assess the situation and initiate appropriate management protocols. This may include monitoring liver function and providing supportive care as necessary. Early recognition and treatment are essential to mitigate the potential for serious complications associated with acetaminophen overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions have been reported, including skin reddening, blisters, rash, hives, and facial swelling. Additionally, allergic reactions such as asthma (wheezing) and shock have been documented.

Further reports indicate occurrences of nervousness, dizziness, and sleeplessness in patients following the use of the product. These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients who are pregnant or breastfeeding should be encouraged to consult a healthcare professional prior to using the medication. It is important to stress the necessity of adhering to the recommended dosage and to avoid exceeding it.

Providers should inform patients that the medication may cause significant drowsiness and recommend avoiding alcoholic beverages during treatment. Additionally, patients should be made aware that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Caution should be advised regarding activities that require alertness, such as driving a motor vehicle or operating machinery, due to the potential for drowsiness. Providers should also inform patients that excitability may occur, particularly in children.

Patients should be encouraged to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm (mucus), difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Finally, healthcare providers should recommend that patients ask a doctor or pharmacist before using the medication if they are currently taking the blood-thinning medication warfarin or any 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 temperatures do not exceed 25°C (77°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 4 hours. Patients should not exceed 10 softgels within a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Nighttime Cold and Flu Max Softgels Maximum Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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