Night Time Cold and Flu Relief

Description

This formulation contains acetaminophen, a pain reliever and fever reducer, dextromethorphan hydrobromide, a cough suppressant, and doxylamine succinate, an antihistamine. The product is alcohol-free and is presented in the form of softgels, specifically liquid-filled capsules.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each product label to confirm appropriate dosing and avoid exceeding the maximum dosage.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• Exceeding the recommended dosage is contraindicated to prevent potential toxicity.

• Consumption of alcoholic beverages is contraindicated due to the risk of increased adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury: do not exceed 4,000 mg of acetaminophen within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it 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.

Healthcare professionals must emphasize the importance of adhering to the recommended dosage, as exceeding this can lead to liver damage. 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, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should also be instructed to stop using the product and consult a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which can lead to liver damage, 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 in the absence of noticeable symptoms.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance without delay. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients should exercise caution when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug 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 or emotional conditions, and Parkinson's disease. Co-administration may lead to serious and potentially life-threatening interactions.

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 pharmacodynamic interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Individualized assessment and careful consideration of the patient's overall health status and comorbidities are recommended to ensure safe and effective use.

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 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 mothers.

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 patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. 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.

It is advised that patients with liver disease consult a healthcare professional prior to use. During the course of treatment, patients are strongly encouraged to avoid alcoholic beverages to minimize the risk of liver damage.

In the event of an overdose, which can lead to significant liver injury, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the potential for liver damage necessitates a high index of suspicion in cases of suspected overdose. Monitoring and supportive care may be required, and specific management protocols should be followed based on the severity of the overdose and the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen, including skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Patients should be advised not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. 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 present.

Healthcare providers should inform patients that excitability may occur, particularly in children. It is also important to counsel patients to avoid alcoholic beverages, as the consumption of alcohol can exacerbate drowsiness. Patients should be made aware that marked drowsiness may occur and that the use of alcohol, sedatives, and tranquilizers can further increase this drowsiness.

Additionally, patients should be cautioned about the potential risks associated with driving a motor vehicle or operating machinery while under the influence of this medication, as drowsiness may impair their ability to perform these tasks safely.

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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Night Time Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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