Day-Time

Description

MARKET BASKET ® is a liquid formulation containing active ingredients including acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The product is packaged in a volume of 12 FL OZ (354 ML).

It is important to note that the product should not be used if the imprinted shrink band is missing or broken, as failure to adhere to this warning may result in serious consequences. This product is not manufactured or distributed by Proctor and Gamble, the owner of the registered trademark Vicks® Dayquil®.

MARKET BASKET ® is distributed by Demoulas Supermarkets Inc., located at 875 East Street, Tewksbury, MA 01876. Lot number and expiration date are to be determined.

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, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The medication should be taken only as recommended, adhering to the overdose warning. A dosage cup or tablespoon (TBSP) should be utilized for accurate measurement. It is imperative not to exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 TBSP) every 4 hours. For children aged 6 years to under 12 years, the dosage is 15 mL (1 TBSP) every 4 hours. For children aged 4 years to under 6 years, consultation with a healthcare professional is advised before administration. The medication is not recommended for children under 4 years of age.

When utilizing both Day Time and Night Time products, it is essential to carefully read each label to ensure correct dosing is achieved.

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, as well as for two weeks following the cessation of MAOI therapy. 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 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.

Additionally, the product should not be used in excess of the directed dosage, and consumption of alcoholic beverages should be avoided due to 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, 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.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience any of the following: nervousness, dizziness, sleeplessness, the emergence of new symptoms, worsening fever lasting more than 3 days, or if pain or cough worsens or persists beyond 5 days in children or 7 days in adults. Additionally, any signs of redness or swelling should prompt immediate medical consultation, as should a cough that recurs or is accompanied by a rash or headache lasting longer than expected.

In cases of severe skin reactions, patients must seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 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 cases of overdose, which can lead to serious health complications including liver damage, immediate medical attention is crucial. Patients should seek professional assistance or contact a Poison Control Center without delay, even if no symptoms are initially apparent.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients are advised to discontinue use and seek medical help immediately.

In addition, patients should consult a doctor 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.

Patients are advised to stop use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, sleeplessness, or if new symptoms arise. Additionally, if fever worsens or lasts more than three days, or if pain or cough intensifies or persists beyond five days in children or seven days in adults, medical advice should be sought. The presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected, may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or a cough accompanied by excessive phlegm should also seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a healthcare professional prior to use.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on a prescription MAOI or for a period of two weeks following the discontinuation of the MAOI treatment. This precaution is essential due to the potential for serious interactions that may arise from the combination of these agents.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a commonly prescribed anticoagulant. Patients are encouraged to consult with their healthcare provider or pharmacist prior to initiating this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety and to mitigate the risk of adverse effects associated with this combination.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive a dosage of 15 mL (1 tablespoon) every 4 hours. For children aged 4 years to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns or modifications indicated for this population in the available data. However, healthcare providers should remain vigilant in monitoring the overall health status of geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this age group. Regular assessment and individualized treatment plans are recommended to ensure optimal therapeutic outcomes.

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 understood. 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 regarding 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

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. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also critical for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is contraindicated due to the heightened risk of severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage.

Recommended Actions In cases of accidental overdose, it is imperative to seek professional medical assistance immediately. Healthcare professionals should be contacted, or a Poison Control Center should be reached without delay.

Symptoms and Management Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risks associated with overdose and improve patient outcomes.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether a drug contains acetaminophen.

Patients should be informed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if new symptoms arise, if fever worsens or persists for more than three days, or if pain or cough intensifies or lasts longer than five days in children or seven days in adults. Patients should also be instructed to stop use and consult a doctor if they notice any redness or swelling, or if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be cautioned against exceeding the recommended dosage and should be made aware of the overdose warning. They should also be advised to avoid alcoholic beverages while using this product.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough accompanied by excessive phlegm (mucus) or if they are taking 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; 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 Day-Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)