Nighttime Cold and Flu

Description

Cold and Flu Nighttime is presented in a carton containing 24 tablets. This formulation is designed to provide relief from symptoms associated with cold and flu during nighttime hours. The product is intended for use in alleviating discomfort and promoting restful sleep.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours, not to exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 softgels within a 24-hour period, combine this product with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using this product.

Acetaminophen is also associated with the potential for 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.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be advised to discontinue use and contact their healthcare provider if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual also necessitate immediate medical consultation.

In cases of overdose, it is critical to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Rapid medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Patients may experience a range of adverse reactions while using this product, which can be categorized by seriousness and frequency.

Severe liver damage is a significant concern associated with the use of this product. This risk is heightened if patients exceed the maximum daily dosage of 8 softgels within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant for severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Additionally, patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days, fever that worsens or lasts more than three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Co-administration 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 such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious adverse effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals on the anticoagulant warfarin should seek advice from a healthcare provider before using this medication. The interaction may alter the anticoagulant effect, necessitating careful monitoring of INR levels and potential dosage adjustments.

It is important to note that the consumption of alcohol, along with sedatives and tranquilizers, may further increase drowsiness, which could impair the ability to perform tasks requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu (dextromethorphan hydrobromide, acetaminophen, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age.

Caution is advised as excitability may occur, particularly in pediatric patients. In the event of an overdose, it is crucial to seek immediate medical attention for children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns when using this product. However, it is important to note that the product has the potential to cause marked drowsiness, which could be particularly concerning for this population.

Due to the risk of drowsiness, elderly patients should exercise caution when driving a motor vehicle or operating machinery. It is advisable for these patients to consult with a healthcare provider prior to use, especially if they have any underlying health conditions or are concurrently taking other medications, particularly sedatives or tranquilizers. This consultation can help ensure safe and effective use of the product in the geriatric 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 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

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 maximum daily dosage of 8 softgels within a 24-hour period. Additionally, patients should avoid concomitant 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 to fewer than 3 alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Taking more than 8 softgels within a 24-hour period, which is the maximum daily dosage for this product, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this dosage.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption during treatment and consider this factor when evaluating the risk of overdosage.

In the event of suspected overdosage, immediate medical attention is recommended. Monitoring liver function and providing supportive care are essential components of management.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

It is essential to caution patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients must adhere strictly to the recommended dosage and be aware that excitability may occur, particularly in children. Marked drowsiness is another potential effect, and patients should be advised to avoid alcoholic beverages while using this product. Caution should be exercised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult their healthcare provider before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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)