Nighttime Cold and Flu

Description

NIGHTTIME COLD AND FLU CAPSULES are provided in a bulk shipment containing 4000 capsules. The product is identified by the National Drug Code (NDC) number 53345-006-01. It is essential to inspect the shipment immediately upon receipt to ensure product integrity. This formulation is intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the capsules should be protected from heat, humidity, and light, and refrigeration is not recommended.

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 associated with this drug.

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. 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 to swallow two softgels with water every six hours.

For children aged 4 to 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not recommended for use in children under 4 years of age.

When using both NIGHTTIME and DAYTIME softgels, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• Administration to induce sleep in children is contraindicated, as it may pose safety risks.

Additionally, it is advised not to exceed the recommended dosage or use the product for more than 7 days. Alcoholic beverages should be avoided, as they may enhance drowsiness when combined with this product.

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 4 doses within a 24-hour period, which is the maximum daily amount. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General precautions must be emphasized to ensure safe use of this product. Patients should not exceed the recommended dosage and should refrain from using the product for more than 7 days. It is important to note that excitability may occur, particularly in children, and marked drowsiness may also be experienced. Patients are advised to avoid alcoholic beverages, as the combination of alcohol with sedatives or tranquilizers may enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for impaired alertness.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if swelling or redness occurs, if symptoms do not improve or are accompanied by a fever lasting more than 3 days, or if new symptoms develop. For coughs, patients should be advised to consult a physician if the cough persists for more than 7 days in adults or 5 days in children, recurs, or is accompanied by fever, rash, or a persistent headache.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions.

Severe liver damage may occur if patients exceed four doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen or if patients consume three or more alcoholic drinks daily while using this product.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, sleeplessness, swelling, or redness. Patients should also seek medical advice if symptoms do not improve, are accompanied by a fever lasting more than three days, or if new symptoms develop. In adults, a cough lasting more than seven days, or in children, a cough lasting more than five days, particularly if it recurs or is accompanied by fever, rash, or persistent headache, should prompt a consultation with a healthcare provider.

Before using this product, patients with liver disease, glaucoma, excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should seek medical advice. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare professional prior to use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist to avoid potential interactions.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI.

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.

Additionally, caution is advised for patients taking the anticoagulant warfarin. It is recommended that these patients seek guidance from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

The concomitant use of alcohol, sedatives, and tranquilizers with this medication may lead to increased drowsiness, necessitating careful monitoring of patients for excessive sedation.

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 aged 4 to 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

Cough symptoms persisting for more than 5 days in children, or more than 7 days in adults, or accompanied by fever, rash, or persistent headache may indicate a serious underlying condition and require medical evaluation.

Marked drowsiness and excitability may occur, particularly in children.

An overdose warning is applicable; exceeding the recommended dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 amount of 4 doses 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. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the risk of severe liver damage. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment.

Overdosage

Severe liver damage may occur with an overdose of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical points regarding overdosage.

Maximum Daily Dosage The maximum recommended dosage is four doses within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products Patients should be cautioned against the concurrent use of this product with other medications that also contain acetaminophen. This practice can lead to unintentional overdose and subsequent liver damage.

Alcohol Consumption The risk of liver damage is further heightened in individuals who consume three or more alcoholic drinks daily while using this product. Healthcare providers should assess patients' alcohol intake and advise accordingly.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Prompt recognition and management of acetaminophen overdosage are essential to mitigate the risk of severe liver damage.

Nonclinical Toxicology

No relevant information regarding teratogenic or non-teratogenic effects has been identified. Additionally, there are no findings related to nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients taking acetaminophen. Additionally, there have been reports of acute liver failure associated with the use of acetaminophen, particularly in patients with underlying liver disease or those who exceed the recommended dosage. Cases of allergic reactions, including anaphylaxis, have also been documented. Furthermore, gastrointestinal bleeding has been reported in patients using nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with acetaminophen. Postmarketing data indicate that some patients may experience drowsiness, dizziness, or confusion, especially when the product is taken alongside other central nervous system depressants.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. They should emphasize the importance of adhering to the recommended dosage, as taking more than the prescribed amount could lead to serious health complications. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If patients are uncertain about the contents of their medications, they should be encouraged to consult a healthcare professional.

It is critical to advise patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be instructed to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should not use this medication to induce sleep in children. They should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if any swelling or redness occurs, or if symptoms do not improve after three days or are accompanied by a fever, patients should seek medical advice. Coughs that persist for more than seven days in adults or five days in children, recur, or are associated with fever, rash, or a persistent headache should also prompt a consultation with a healthcare provider, as these may indicate a more serious condition.

While using this product, patients should be cautioned against exceeding the recommended dosage and should not use it for more than seven days. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should avoid consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be advised to exercise caution when driving or operating machinery while using this medication. It is important for patients to consult a healthcare provider before use if they have liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, or who are taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from a healthcare professional prior to use.

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, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older should swallow 2 softgels with water every 6 hours. For children aged 4 to 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use. It is crucial to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dose may lead to serious health issues. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, regardless of the presence of 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)