Night Time Severe Cold and Flu

Description

Walgreens Severe Nighttime Cold & Flu Relief is a maximum strength liquid formulation designed to alleviate symptoms associated with cold and flu. The product contains the following active ingredients: acetaminophen, a fever reducer; dextromethorphan HBr, a cough suppressant; diphenhydramine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant.

The formulation is presented in an original flavor and is packaged in an 8 fluid ounce (237 mL) container. The National Drug Code (NDC) for this product is 0363-0331-26. It is distributed by Walgreen Co., located at 200 Wilmont Rd., Deerfield, IL 60015. The product includes an imprint warning indicating that it should not be used if the imprinted shrink band is missing or torn.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, sore throat, headache, minor aches and pains, runny nose, and sneezing. Additionally, it temporarily reduces fever and alleviates cough due to minor throat and bronchial irritation. The formulation also promotes nasal and/or sinus drainage.

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

Dosage and Administration

The medication should be taken only as recommended. It is advised to use a dose cup or tablespoon (TBSP) for accurate measurement. The maximum allowable doses should not 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 4 to under 12 years, it is essential to consult a healthcare professional for appropriate dosing. The medication is not recommended for children under 4 years of age.

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) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for 2 weeks following the discontinuation of MAOIs, as this may lead to serious drug interactions.

• Administration for the purpose of inducing sleep in children is contraindicated, as it may pose safety risks.

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 mitigate 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 daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that 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.

General precautions should be observed, including keeping this product out of reach of children. In the event of an overdose, immediate medical attention is crucial. Patients and caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if they experience any of the following: nervousness, dizziness, sleeplessness, redness or swelling, worsening pain, nasal congestion, or cough lasting more than 7 days, fever worsening or lasting more than 3 days, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 4 doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Furthermore, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain, nasal congestion, or cough worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients are advised to consult a healthcare professional before using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects and increase the risk of drowsiness.

Furthermore, caution is warranted when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should seek guidance from a healthcare provider prior to combining these treatments to ensure appropriate monitoring and dosage adjustments if necessary.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may further increase drowsiness, necessitating careful consideration of the overall treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Severe 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. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should evaluate the individual circumstances of each patient to ensure the safety of both the mother and the fetus.

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 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 advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks daily while using this product. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of dosage and adherence to these guidelines is essential to minimize the risk of severe liver damage.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Administration of more than four doses within a 24-hour period, which constitutes the maximum daily allowance, can lead to severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a substantial risk for severe liver damage. It is crucial for healthcare providers to assess a patient's complete medication history to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Considerations Patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption in conjunction with this medication and consider alternative treatment options if necessary.

In the event of suspected overdosage, immediate medical evaluation is recommended to assess liver function and initiate appropriate management strategies.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, 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. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this medication to induce sleep in children. They should be advised to stop using the product and consult a doctor if they experience symptoms such as nervousness, dizziness, sleeplessness, redness or swelling, worsening pain, nasal congestion, or cough lasting more than seven days, or if fever worsens or lasts more than three days. New symptoms or a cough that returns with a rash or headache that persists should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients should be instructed not to exceed the recommended dosage and to avoid alcoholic beverages, as marked drowsiness may occur. Patients should be made aware that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Finally, patients should be encouraged to consult their doctor or pharmacist before using this medication if they are taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)