Nighttime 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 common cold and flu symptoms, including 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 as needed. 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 medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

The product is also contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare professional if their prescription medication contains an MAOI.

Additionally, it is important to adhere to the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications containing acetaminophen or consume three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms arise, patients must 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 instructed to consult a physician without delay.

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 advised to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be instructed to discontinue use 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 develops; new symptoms emerge; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring further evaluation.

Side Effects

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

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. In cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are present. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay in such situations.

Additionally, acetaminophen may cause 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 promptly.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring medical consultation.

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

Patients should discontinue use and consult a healthcare provider 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 observed, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms could signify a serious underlying condition.

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 Nighttime Cold and Flu (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 patients 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 exhibit increased sensitivity to the side effects of this product. It is important for healthcare providers to consider this heightened sensitivity when prescribing and monitoring treatment in this population.

Dosage adjustments may be necessary for geriatric patients, particularly due to the potential for reduced kidney function that can occur with aging. Careful assessment of renal function is recommended to determine the appropriate dosage and to avoid adverse effects.

Special precautions should be taken when administering this product to elderly patients, especially those with liver disease or other underlying health conditions. Close monitoring of these patients is advised to ensure safety and efficacy of the treatment.

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 currently no available data on the excretion of this medication 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 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 be aware of the potential risks associated with the use of this product, which contains acetaminophen. 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.

It is advised that patients with liver disease consult a healthcare professional prior to using this product. 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. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of this medication can lead to significant liver damage. It is imperative that healthcare professionals recognize the seriousness of an overdose and act swiftly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate potential complications associated with liver damage.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe skin reactions, which include skin reddening, blisters, and rash.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage of the medication, 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 assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be informed that excitability may occur, particularly in children, and they should be cautious about engaging in activities that require full attention. Marked drowsiness is a potential side effect, and patients should be made aware that the use of alcohol, sedatives, and tranquilizers can exacerbate this drowsiness. Therefore, it is advisable for patients to avoid alcoholic beverages while taking this medication.

Additionally, healthcare providers should emphasize the importance of exercising caution when driving a motor vehicle or operating machinery due to the risk of drowsiness associated with the medication.

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 Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)