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 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 to avoid the risk of 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 should not be crushed, chewed, or dissolved prior to ingestion.

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 label to ensure accurate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication 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.

Additionally, this product is 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, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Exceeding the recommended dosage can result in liver damage. In cases of overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions include avoiding the use of this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Before using this product, patients should seek medical advice if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or a chronic cough or breathing problem, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

While using this product, it is essential to adhere to the recommended dosage. Patients should be aware that excitability may occur, particularly in children, and marked drowsiness may be experienced. The consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, necessitating caution when driving or operating machinery.

Patients should discontinue use and contact a healthcare provider if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who 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 clinical trials and postmarketing experiences, it has been noted that taking more than the recommended dosage can lead to significant liver injury. In the event of an overdose, immediate medical assistance should be sought, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is crucial for both adults and children.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients with liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should consult a doctor before using this product. Furthermore, individuals taking blood thinners like warfarin or sedatives should also seek advice from a healthcare provider prior to use.

While using this product, patients should not exceed the recommended dosage, as excitability may occur, particularly in children. Marked drowsiness is a potential side effect, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Caution is advised when driving or operating machinery.

Patients are advised to discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if fever worsens or lasts 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, as these may indicate a serious 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, and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. In children, the use of this medication may lead to excitability. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent. For patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using 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 a history of liver disease consult a healthcare professional prior to use. During treatment, patients are strongly encouraged to avoid alcoholic beverages to minimize the risk of liver damage.

Patients should be aware that taking more than the recommended dose can lead to significant liver injury. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) 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

In cases of overdosage, the administration of doses exceeding the recommended amount may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of such an event.

Immediate medical assistance is crucial. In the event of an overdose, it is recommended to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as prompt intervention can mitigate the risk of severe complications.

Healthcare providers should be aware that symptoms may not be immediately apparent. Therefore, even in the absence of noticeable signs or symptoms, swift medical evaluation is advised to ensure the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may 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. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be cautioned against exceeding the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be warned to exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Additionally, patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. They should also seek medical advice if they have a cough that produces excessive phlegm.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin or if they are using 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 a temperature range of 15-30°C (59-86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this 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

Patients aged 12 years and older are instructed to take 2 softgels orally with water every 6 hours, ensuring that the softgels are swallowed whole and not crushed, chewed, or dissolved. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.

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