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 minor aches and pains, headache, sore throat, 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

Adults and children aged 12 years and over are advised to take 30 mL every 6 hours as needed. It is important not to exceed 4 doses within a 24-hour period. The medication should be measured exclusively with the dosing cup provided; the use of any other dosing device is not recommended.

For children under 12 years of age, the use of this medication is contraindicated. When administering this product in conjunction with other Daytime or Nighttime formulations, healthcare professionals should ensure that each label is carefully read to confirm appropriate dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is any doubt about the presence of acetaminophen in other medications, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4000 mg of acetaminophen within a 24-hour period, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients must be advised to stop taking this product and consult a doctor if any of the following occur: worsening pain or cough lasting more than seven days, fever worsening or persisting beyond three days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting. 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 if patients exceed 4000 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, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Patients should also be alert to the possibility of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

In addition, 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 immediately.

Patients are advised to stop using the product and consult a doctor if pain or cough worsens or lasts 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 persists. These symptoms may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. It is recommended that patients avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for increased drowsiness.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr, 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. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness can be a side effect of this product. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 lack of targeted data for 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 safe use during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed 4000 mg of acetaminophen in a 24-hour period, as exceeding this limit may lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should 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 quick intervention can mitigate the risk of severe complications, even if no immediate signs or symptoms are apparent.

Healthcare providers should remain vigilant and ensure that patients and caregivers are aware of the importance of timely medical evaluation following an overdose.

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 that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include 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

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with a doctor or pharmacist prior to using this product.

It is important to instruct patients not to combine this product with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be advised to discontinue use and consult a doctor 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 seek medical advice if new symptoms arise or if a cough returns, particularly if accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery. Additionally, patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should be advised to consult a doctor before using this product. Furthermore, those experiencing difficulty urinating due to an enlarged prostate gland, as well as patients 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 configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25ºC (68-77ºF). It is imperative to avoid refrigeration to maintain product integrity. Proper handling and storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. Patients should be warned about the risks of overdose, which can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised, as prompt medical attention is crucial for both adults and children, 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.

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