Night-Time

Description

MARKET BASKET® is a night-time multi-symptom cold and flu relief formulation. It contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. The product is flavored with cherry and is available in a volume of 12 fluid ounces (354 mL).

The product is manufactured in the USA and is distributed by Demoulas Supermarkets Inc., located at 875 East Street, Tewksbury, MA 01876. A warning is included stating that the product should not be used if the imprinted shrink band is missing or broken. It is important to note that this product is not manufactured or distributed by Proctor and Gamble, the distributor of Vicks® Nyquil®. The revision code for this product is LR - 035 REV01.

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 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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• The product should not be used to induce sleepiness in children.

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, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding the management of sore throat symptoms. If a patient presents with a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be advised to stop using the product and consult a healthcare professional if any of the following occur: redness or swelling at the site of application, 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 occurs alongside fever, rash, or a headache lasting longer than usual. These symptoms may indicate a serious underlying condition.

In cases of severe skin reactions, immediate medical attention is essential. Healthcare professionals should ensure that patients are aware of these critical warnings and the importance of monitoring their symptoms closely.

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 contacting a Poison Control Center is advised. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially 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, it is imperative to discontinue use and seek medical help immediately.

In clinical practice, patients are advised to stop using the product and consult a healthcare provider if they experience redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or persists beyond three days, or if new symptoms arise. Additionally, if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, these may indicate a serious condition requiring medical evaluation.

Patients with specific health concerns should consult a doctor 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. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

It is also recommended that patients consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the product.

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) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

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.

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 in conjunction with this medication, as these substances may significantly increase drowsiness. Monitoring for increased sedation 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 for potential excitability, which may occur particularly in children. Additionally, marked drowsiness has been reported, necessitating caution in this population. It is essential to keep the 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 critical 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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period, as exceeding this limit may result in severe liver damage.

Additionally, patients must be aware that the concurrent use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, individuals who consume three or more alcoholic drinks daily should avoid using this product, as this combination significantly increases the risk of severe liver damage.

Monitoring of liver function is advised in patients with compromised liver function 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 onset of symptoms may not be immediately apparent.

Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The potential for serious health issues necessitates a proactive approach to managing suspected overdosage cases.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific details, and there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

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 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 emphasize that if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious condition. Patients must 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, or tranquilizers may enhance drowsiness.

Before using this product, patients should consult their healthcare provider 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, 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 assigned 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

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)