Daytime

Description

This product is a liquid formulation containing active ingredients including acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and phenylephrine HCl, acting as a nasal decongestant. The product is packaged in a 6 fluid ounce (177 mL) container. It is important to note that this product is not manufactured or distributed by Proctor and Gamble, the owner of the registered trademark Vicks® Dayquil®.

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. For accurate dosing, a dosage cup or tablespoon (TBSP) should be utilized.

For adults and children aged 12 years and over, 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, it is advised to consult a physician before administration. The medication is not recommended for children under 4 years of age.

It is important to note that the maximum allowable doses should not exceed 4 doses within a 24-hour period. When using both Day Time and Night Time products, healthcare professionals should ensure that patients carefully read each label to confirm correct dosing.

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 discontinuation of an MAOI, due to the risk of serious interactions.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated to prevent potential overdose and liver damage.

Additionally, patients should not exceed the recommended dosage, and the consumption of alcoholic beverages should be avoided while using this product.

Warnings and Precautions

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage is 4 doses (30 mL each) for adults and 4 doses (15 mL each) for children within a 24-hour period. Caution is particularly warranted if the patient is concurrently using other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

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

Monitoring and Consultation Patients should be advised to stop use and consult a healthcare professional if they experience any of the following: nervousness, dizziness, sleeplessness, the emergence of new symptoms, worsening fever lasting more than three days, or pain and cough that persists beyond five days in children or seven days in adults. Additionally, any presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache warrants immediate medical evaluation, as these may indicate a serious underlying condition.

Emergency Medical Help In the event of a skin reaction, patients must be instructed to stop using the product and seek emergency medical help without delay.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using the product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Overdose of this product can lead to serious health complications, including liver damage. Patients who suspect an overdose should seek professional medical assistance or contact a Poison Control Center without delay, as timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if new symptoms arise, if fever worsens or lasts more than 3 days, or if pain or cough intensifies or persists beyond 5 days in children or 7 days in adults. Additionally, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a healthcare provider 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. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or those experiencing a cough with excessive phlegm should also seek medical advice prior to use. Patients taking the blood-thinning medication warfarin should consult a doctor before using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to use to assess the potential for increased bleeding risk and to determine if any dosage adjustments or monitoring are necessary.

Additionally, this medication should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. The combination may lead to serious adverse effects, and appropriate monitoring or alternative therapies should be considered during this period.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime (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, with a maximum of 4 doses (15 mL each) in a 24-hour period. 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 using this product, as no safety concerns have been identified in the provided information. However, it is important to note that the product contains acetaminophen, which can pose risks for individuals with liver disease. Given that liver disease may be more prevalent among geriatric patients, careful consideration is warranted.

Healthcare providers are advised to consult with elderly patients regarding their liver health prior to initiating treatment with this product. This precaution is particularly relevant for those with a known history of liver disease, as it may influence the safety and efficacy of the medication in this population. Regular monitoring and assessment of liver function may be beneficial in managing potential risks associated with acetaminophen use in 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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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. Severe liver damage may occur if the following conditions are met:

• An adult exceeds 4 doses (30 mL each) within a 24-hour period, which is the maximum daily amount for this product.

• A child exceeds 4 doses (15 mL each) within a 24-hour period, which is also the maximum daily amount for this product.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using the product.

Due to the potential for severe liver damage, it is essential for healthcare providers to assess liver function and consider dosage adjustments or restrictions 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 this medication can lead to serious health complications, particularly liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdose.

In the event of an accidental overdose, immediate professional assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Prompt action can significantly mitigate the risks associated with excessive dosing and improve patient outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning 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, users are advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children. It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. Patients who are unsure whether their prescription drug contains an MAOI should be encouraged to consult with their doctor or pharmacist before taking this product.

Patients should also be cautioned against using this medication in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should seek guidance from a healthcare professional.

Healthcare providers should instruct patients to stop using the product and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness, if new symptoms arise, if a 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. Additionally, patients should seek medical advice if they notice redness or swelling, or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage and to avoid consuming alcoholic drinks.

Providers should also recommend that patients consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients with a cough accompanied by excessive phlegm (mucus) should also seek medical advice prior to use.

Lastly, it is essential to advise patients to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin.

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 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 Daytime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)