Nighttime Cold and Flu

Description

This formulation contains acetaminophen, dextromethorphan HBr, and doxylamine succinate, which are comparable to the active ingredients found in Vicks® Nyquil® Cold & Flu. The product is presented in a cherry flavor and includes 10% alcohol. It is packaged with a tamper-evident safety seal; usage is not recommended if the seal around the dosage cup or under the cap is broken or missing. The product is distributed by GoBrands, Inc., located in Philadelphia, PA 19123.

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

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the prescribed dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing.

Children under 12 years of age should not use this product. When administering this medication in conjunction with other Day Time or Night Time products, healthcare professionals are advised to carefully review each label to confirm appropriate dosing and avoid potential overdose.

Patients should be cautioned against exceeding the directed dosage, as outlined in the Overdose warning. The dosing cup should be kept with the product to facilitate proper measurement.

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 interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must 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 instructed to stop use and consult a healthcare professional if any of the following occur: worsening pain or cough lasting more than seven days, the emergence of new symptoms, worsening fever lasting more than seven days, presence of redness or swelling, or recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be cautioned about the risk of excitability, particularly in children, and marked drowsiness, which may occur during use. It is advisable to avoid alcoholic beverages, as well as sedatives and tranquilizers, as these may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery.

Patients are advised to stop use and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 7 days, if redness or swelling is observed, or if cough recurs with a rash or headache lasting longer than expected. These symptoms could indicate a serious condition.

In cases of overdose, which may result from exceeding the recommended dosage, patients are at risk for liver damage. Immediate medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Patients should contact a Poison Control Center (1-800-222-1222) without delay in the event of an overdose.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking a prescription MAOI or for a period of two weeks following the discontinuation of the MAOI treatment.

Caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy if they are currently taking these classes of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may necessitate monitoring or dosage adjustments.

It is important to note that the use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness, which could impact the patient's ability to perform tasks that require alertness.

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 product. When administered to children, excitability may occur, and marked drowsiness is also a potential side effect. In the event of an overdose, it is critical to seek quick medical attention for both adults and children, even if no signs or symptoms are immediately apparent. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, 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, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its consequences.

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 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt evaluation and management, even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in the event of an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 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 immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

When using this product, patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is important to counsel patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should also be cautioned to exercise care when driving a motor vehicle or operating machinery.

Patients should be instructed to stop using the product and consult a doctor if their pain or cough worsens or persists for more than 7 days, if new symptoms arise, if fever worsens or lasts beyond 7 days, if redness or swelling is observed, or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition.

Healthcare providers should recommend that patients consult a doctor before using the product if they have liver disease, glaucoma, a cough associated with excessive phlegm, a breathing problem or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland.

Additionally, patients should be advised to speak with a doctor or pharmacist before using the product if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 20º-25ºC (68º-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

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 children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Patients should be instructed to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential 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.

View product document (PDF)