Night-Time

Description

MARKET BASKET® is a night-time multi-symptom cold and flu relief formulation that compares to the active ingredients in VICKS® NYQUIL®. The product contains Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; and Doxylamine Succinate, an antihistamine. It is available in an original flavor and is packaged in a 12 FL OZ (354 mL) bottle.

The product is manufactured in the USA and is distributed by Demoulas Supermarkets Inc., located at 875 East Street, Tewksbury, MA 01876. It is important to note that the product should not be used if the imprinted shrink band is missing or broken. This product is not manufactured or distributed by Proctor & Gamble, the distributor of VICKS® NYQUIL®.

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, minor aches and pains, runny nose, sneezing, cough due to minor sore throat and bronchial irritation, headache, and fever.

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 specified dosage guidelines to avoid the risk of overdose.

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 utilizing both Night Time and Day Time formulations, it is imperative to ensure that the total number of doses does not exceed four within the same 24-hour timeframe. This precaution is essential for maintaining patient safety and efficacy of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• Administration to induce sleepiness in children is contraindicated, as it may pose safety risks.

• Exceeding the recommended dosage is contraindicated to prevent potential adverse effects.

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 following guidelines to minimize the risk of liver injury: do not exceed 4 doses within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Patients experiencing a sore throat should be monitored closely. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare provider promptly.

Patients should be advised to discontinue use and contact their healthcare provider if any of the following occur: redness or swelling at the site of use, lack of improvement in symptoms within 7 days, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache lasting longer than usual. These symptoms may indicate a serious underlying condition requiring further evaluation.

In cases of severe adverse reactions or if patients exhibit concerning symptoms, they should seek emergency medical help as necessary.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed four doses 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. In the event of an overdose, which can lead to serious health complications, immediate medical assistance should be sought, and patients are advised to contact a Poison Control Center without delay, as prompt intervention is crucial for both adults and children.

Patients may also experience severe skin reactions due to acetaminophen, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately.

In addition, patients should consult a healthcare provider 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. Other concerning symptoms that warrant medical consultation include redness or swelling, symptoms that do not improve within seven days or are accompanied by fever, worsening fever lasting more than three days, the emergence of new symptoms, or a cough that lasts more than seven days or recurs with fever, rash, or headache, as these may indicate a serious condition.

Patients with specific health concerns should seek medical advice before using this product. This includes individuals on a sodium-restricted diet, those with liver disease, glaucoma, chronic cough associated with excessive mucus, or breathing problems such as asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider prior to use.

Furthermore, it is advisable for patients to discuss their use of this product with a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as interactions may occur.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

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. This interaction may lead to serious adverse effects, including hypertensive crises.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding due to potential interactions.

Caution is advised when consuming alcohol, as it may further increase drowsiness when taken in conjunction with this medication, along with other sedatives and tranquilizers. Monitoring for excessive sedation and other related effects is recommended in such cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be monitored closely due to the potential for excitability, which may occur particularly in children. Marked drowsiness is also a possible side effect that requires attention. 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. Quick 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 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 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, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount.

Additionally, patients should be advised against the concurrent use of this product with other medications containing acetaminophen, as this can further increase the risk of liver damage.

Patients who consume 3 or more alcoholic drinks daily should exercise caution, as the combination of alcohol and acetaminophen may also lead to severe liver damage.

Due to these risks, it is recommended that healthcare providers assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted to ensure patient safety.

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 severity of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of acting swiftly even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of the critical nature of seeking medical help in cases of suspected overdose, reinforcing the need for vigilance and timely action.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, no findings from animal pharmacology and toxicology studies have been provided.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued and medical assistance be sought immediately.

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 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. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleepiness in children. They should be instructed to discontinue use and seek medical advice if they experience redness or swelling, if symptoms do not improve within seven days, or if symptoms are accompanied by a fever. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or persists for more than three days, or if new symptoms arise.

Healthcare providers should inform patients that if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, they should seek medical attention, as these may indicate a serious condition. Patients should be reminded to adhere strictly to the recommended dosage and to avoid alcoholic beverages while using this product.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Caution should be advised when driving or operating machinery due to the potential for drowsiness. Furthermore, patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be encouraged to consult a doctor if they are on a sodium-restricted diet, have liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)