Night-Time Original

Description

NDC 68016-144-01. Premier Value® Original Night-Time Multi-Symptom Cold/Flu Relief is formulated to provide relief from multiple cold and flu symptoms. The active ingredients include Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; and Doxylamine Succinate, an antihistamine. This product is available in a liquid dosage form, with a volume of 12 FL OZ (354 mL). It is independently tested for satisfaction and is guaranteed by Premier Value®. The product should not be used if the printed seal under the cap is torn or missing. This formulation is not manufactured or distributed by Procter and Gamble, the owner of the registered trademark Vicks® NyQuil®. For any dissatisfaction, the product can be returned to the store of purchase for a full refund. Distributed by Chan Drug Consortium, located at 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431. LR-024.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. These symptoms include sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor sore throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as recommended, adhering to the guidelines outlined in the Overdose warnings. The medication should be measured using a dose cup or a tablespoon (TBSP) for accurate dosing.

The maximum allowable dosage is four doses within a 24-hour period. When administering both Night Time and Day Time formulations, it is essential to ensure that the total number of doses does not exceed four within the same 24-hour timeframe.

Contraindications

Use of this product is contraindicated in the following situations:

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

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• For the purpose of inducing sleepiness in children, as this is not an approved indication.

Additionally, while using this product, it is essential to adhere to the recommended dosage and avoid the consumption of alcoholic beverages, as this may exacerbate drowsiness and other side effects.

Warnings and Precautions

Failure to adhere to the following warnings may result in serious health consequences.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Stop Use and Consult a Doctor If

• Redness or swelling is observed.

• Symptoms do not improve within 7 days or are accompanied by fever.

• Fever worsens or lasts longer than 3 days.

• New symptoms develop.

• A cough persists for more than 7 days, recurs, or occurs alongside fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Healthcare professionals are advised to monitor patients for these signs and symptoms to ensure timely intervention and management.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be 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.

In cases of overdose, patients must obtain immediate medical help or contact a Poison Control Center, as serious health problems can arise from taking more than the recommended dose. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients are instructed to discontinue use and consult a doctor if they notice redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or lasts more than three days, if new symptoms develop, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a headache. These symptoms may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, a 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 seek advice from a doctor or pharmacist prior to use if they are taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

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, and for a period of two weeks following the discontinuation of an MAOI.

Caution is advised when considering the use of this medication in conjunction with sedatives or tranquilizers. Patients should consult a healthcare professional prior to use.

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

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of patients for increased sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Night-Time Original (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely for potential excitability, which may occur particularly in children. Additionally, marked drowsiness has been reported, necessitating caution when administering this medication to pediatric populations.

It is crucial to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both children and adults, even if no signs or symptoms are initially 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 lack of specific data on geriatric use. 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 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 individuals 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 critical to note that severe liver damage may occur if patients exceed 4 doses in a 24-hour period, which is the maximum daily amount when considering other medications that also contain acetaminophen. Additionally, patients consuming 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage. Therefore, it is recommended that patients with compromised liver function adhere strictly to the dosing guidelines and consult with a healthcare professional regarding their alcohol consumption while using this product. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the effects of an overdose may not be immediately apparent. This applies to both adults and children, underscoring the importance of acting swiftly even in the absence of noticeable symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to mitigate the risks associated with overdosage.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are excitability, particularly in children, and marked drowsiness. Additionally, serious health problems have been reported in connection with overdose.

It is emphasized that prompt medical attention is essential for both adults and children in the event of an overdose, even in the absence of noticeable signs or symptoms.

Patient Counseling

Advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct them not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication, which is often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should seek clarification from their healthcare provider if they are unsure whether their prescription includes an MAOI.

Emphasize that this product is not intended to induce sleepiness in children. Patients should be advised to discontinue use and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days, or if symptoms are accompanied by a fever. Additionally, they should stop use and seek medical advice if a fever worsens or persists for more than three days, or if new symptoms arise. Patients should also be informed to stop use and consult a doctor if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

When using this product, patients should adhere strictly to the recommended dosage and avoid consuming alcoholic beverages, as this may exacerbate drowsiness. Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a potential side effect. Caution should be advised when driving a motor vehicle or operating machinery while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they are on a sodium-restricted diet, have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. It is also important for patients to consult a doctor or pharmacist if they are 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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Night-Time Original, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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