Nighttime Cold and Flu Relief

Description

This product is identified by NDC 68016-878-16 and is marketed under the Premier Value® brand. It is formulated to provide multi-symptom nighttime relief from cold and flu symptoms, comparable to the active ingredients found in Vicks® NyQuil® Cold & Flu Nighttime Relief LiquiCaps®. Each capsule contains a combination of acetaminophen (325 mg), dextromethorphan HBr (15 mg), and doxylamine succinate (6.25 mg). The product is supplied in a package containing 16 capsules.

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 two capsules taken with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

When utilizing other Daytime or Nighttime products, 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:

Patients should not use this product in conjunction 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.

The product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Additionally, this product should not be used to induce sleep in children.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as taking more than four doses within a 24-hour period— the maximum daily amount— can lead to significant liver injury. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen, as this increases the risk of overdose. Consumption of three or more alcoholic beverages daily while using this product is also contraindicated due to the heightened risk of liver damage.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to seek medical attention promptly.

Healthcare professionals must emphasize the importance of adhering to the prescribed dosage, as exceeding the recommended amount can result in serious health complications. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Timely medical intervention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or if a cough recurs alongside a rash or headache that lasts.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly concerning liver health and severe throat conditions. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage of 4 doses within 24 hours is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

In clinical observations, patients are advised to seek medical attention if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or lasts longer than seven days, if fever intensifies or persists beyond three days, if there is any redness or swelling, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These could be indicative of a serious condition requiring medical evaluation.

Prior to using this product, patients with liver disease, glaucoma, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should consult a healthcare provider. Additionally, those experiencing cough with excessive phlegm or difficulties urinating due to an enlarged prostate gland should seek medical advice.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin are also advised to consult a doctor or pharmacist before use to avoid potential interactions.

Drug Interactions

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

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and should be avoided for at least 2 weeks after discontinuation of the 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 drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

Caution is advised when consuming alcohol, sedatives, or tranquilizers while using this medication, as these substances may further increase drowsiness and impair cognitive and motor functions.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hbr and 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 medication is not recommended for children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 capsules with water every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center, 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 recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general variability in drug metabolism and sensitivity in this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of this medication for elderly patients.

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 lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 data 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 information necessitates careful clinical judgment and monitoring.

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 under certain conditions. Specifically, patients must not exceed four doses within a 24-hour period, as this is the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver damage.

Furthermore, patients with compromised liver function should be advised against consuming three or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and to mitigate the risk of adverse effects.

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 Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds four doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdosage. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and angioedema. Serious skin reactions have also been noted, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Instances of liver injury, including cases of acute liver failure, have been documented.

Gastrointestinal bleeding has been reported, along with renal impairment, which encompasses acute kidney injury. Additionally, cardiovascular events, including myocardial infarction and stroke, have been observed. Respiratory depression has been particularly noted in patients with underlying respiratory conditions.

Patient Counseling

Patients should be advised not to exceed the recommended dosage, as taking more than directed can lead to serious health complications. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Healthcare providers should inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned against consuming alcoholic beverages while using this medication, as alcohol can exacerbate drowsiness.

Additionally, patients should be made aware of the importance of exercising caution when driving or operating machinery, as the medication may impair their ability to do so safely. It is also important to note that the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may further increase drowsiness, and patients should be advised to avoid such combinations.

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 to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 capsules taken with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. Patients should be informed of the overdose warning, emphasizing that exceeding the recommended dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended, 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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