Daytime Nighttime Cold and Flu

Description

The DAY & NIGHT PACK from Walgreens contains two formulations designed to address cold and flu symptoms. The daytime formulation is a non-drowsy multi-symptom relief option that includes acetaminophen for pain relief and fever reduction, dextromethorphan HBr as a cough suppressant, and phenylephrine HCl for nasal congestion. This formulation is free from antihistamines and alcohol.

The nighttime formulation is designed to provide relief from similar symptoms while also addressing sneezing and runny nose with the inclusion of doxylamine succinate, an antihistamine. This formulation contains acetaminophen, dextromethorphan HBr, and has an alcohol content of 10%. Both formulations are cherry-flavored and are packaged in two 12 FL OZ (355 mL) bottles, totaling 24 FL OZ (1.5 pt) (710 mL). The product is comparable to the active ingredients found in Vicks® DayQuil® and 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 cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. The medication is to be taken only as directed, and healthcare professionals should refer to the Overdose warning for further information.

The provided dose cup must be utilized for accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is contraindicated for children under 4 years of age.

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. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric conditions and Parkinson’s disease, and their interaction with this product may lead to serious adverse effects. Verify with a healthcare professional if there is uncertainty regarding MAOI status.

• In individuals with a history of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes three or more alcoholic beverages daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare provider. It is also recommended that patients taking the anticoagulant warfarin consult with a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of whether signs or symptoms are present.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg of acetaminophen within a 24-hour period, and children should not exceed 5 doses 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 three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

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

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever persists for more than 3 days, medical advice should be sought. Patients should also be vigilant for signs of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache, as these may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing urinary difficulties due to an enlarged prostate gland should consult a doctor before using this product. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, as well as those with glaucoma or breathing problems like chronic bronchitis, should also seek medical advice prior to use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare professional or pharmacist before using this product.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Concurrent use of this product with other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in any other medication.

The use of this product is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients should verify with a healthcare provider or pharmacist if their current medications include an MAOI.

Caution is advised when this product is used alongside warfarin, a blood-thinning medication. Monitoring of coagulation parameters may be necessary to ensure patient safety.

Additionally, the concomitant use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Patients should be advised to exercise caution and consider dosage adjustments or monitoring for increased sedation when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. For children under 4 years, the product is contraindicated and should not be used.

In terms of dosing, adults and children aged 12 years and older may take 30 mL every 6 hours for nighttime cold and flu symptoms. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours for daytime cold and flu relief.

Children aged 4 to under 6 years also require consultation with a healthcare professional prior to use.

It is important to note that in cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available information. However, it is essential for healthcare providers to consider general health factors that may be more prevalent in this population.

Before initiating treatment, it is advisable for elderly patients to consult a healthcare professional if they have underlying conditions such as liver disease, heart disease, high blood pressure, or urinary difficulties due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the treatment.

Marked drowsiness is a potential side effect that may occur, which could pose a significant concern for elderly patients. Additionally, the use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and elderly patients may be particularly sensitive to these effects.

For dosing, adults and children aged 12 years and older are directed to take 30 mL every 6 hours at night or 30 mL every 4 hours during the day. For children under 12 years, consultation with a healthcare provider is recommended, and the product should not be used in children under 4 years of age.

Healthcare providers should monitor elderly patients closely for any adverse effects and consider individual patient factors when prescribing this treatment.

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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. Adults should not exceed 4,000 mg of acetaminophen in a 24-hour period, and children should not take more than 5 doses within the same timeframe. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

Patients with a history of alcohol use should be particularly vigilant, as consuming 3 or more alcoholic drinks daily while using this product may also lead to severe liver damage. It is strongly advised that patients with liver disease consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic effects have been observed in the studies conducted. Additionally, there are no reported non-teratogenic effects. The nonclinical toxicology section does not provide any specific details regarding toxicological findings. Furthermore, there are no available data on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Patients are advised to seek medical attention if pain or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days. The presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that persists may indicate a serious condition requiring further evaluation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 30 mL of the product every 6 hours for Nighttime Cold & Flu and every 4 hours for Daytime Cold & Flu. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours for Daytime Cold & Flu. For children aged 4 to under 12 years, it is recommended to consult a doctor regarding the use of Nighttime Cold & Flu, while the product is not recommended for children under 4 years of age for either formulation.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Daytime Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)