Walgreens Nighttime Cold and Flu

Description

No description information is available for the specified drug.

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 recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is to swallow two softgels with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance.

The product is not intended for use in children under 4 years of age.

When utilizing other Daytime or Nighttime products, it is essential to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

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 for the purpose of inducing sleep in children.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Healthcare professionals should advise patients to seek medical attention promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, it is crucial to inform patients that taking more than the recommended dose can lead to serious health complications. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted, as timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken for patients with specific health conditions. Patients should consult a healthcare provider before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. It is advisable for patients to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact a healthcare professional if any of the following occur: pain or cough worsens or persists beyond 7 days; fever worsens or lasts more than 3 days; redness or swelling develops; new symptoms arise; or if a cough recurs alongside a rash or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4 doses in 24 hours, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be advised to seek medical attention if they experience a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. It is also not recommended for use in children to induce sleep.

Patients with liver disease, glaucoma, excessive phlegm, chronic cough, or difficulty urinating due to an enlarged prostate gland should consult a doctor before using this product. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also seek advice from a healthcare professional prior to use.

While using this product, patients should adhere to the recommended dosage to avoid excitability, particularly in children, and marked drowsiness may occur. Alcoholic beverages, sedatives, and tranquilizers can exacerbate drowsiness, and caution is advised when driving or operating machinery.

Patients are instructed to discontinue use and consult a doctor if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

An overdose warning is in place, as taking more than the recommended dose can lead to serious health issues. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of acetaminophen with warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers with this product may potentiate drowsiness. Caution is advised when engaging in activities that require alertness, and dosage adjustments may be necessary based on the patient's response to these combinations.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a doctor before use. In patients 12 years of age and older, the recommended dosage is to swallow 2 softgels with water every 6 hours, with a maximum of 4 doses in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. In the event of an 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 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 prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 no specific data available regarding the excretion of this medication in 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution 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 should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

Taking more than the recommended dose of this 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 effects of an overdose may not be immediately apparent. This is particularly important for both adults and children, as symptoms may not manifest right away, yet the risk of serious health issues remains significant.

Healthcare professionals should ensure that patients and caregivers are aware of the importance of seeking quick medical attention, regardless of the presence or absence of symptoms following an overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis and angioedema. Serious skin reactions have also been noted, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Instances of liver injury, including acute liver failure, have been documented.

Gastrointestinal bleeding and renal impairment have been reported as well. Cardiovascular events, such as myocardial infarction and stroke, have been observed. Additionally, respiratory depression has been particularly noted in patients with underlying respiratory conditions.

Drowsiness and sedation have been reported, especially in children, alongside excitability in the pediatric population. Other adverse reactions include nausea, vomiting, and dizziness.

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 sleep in children. They should be instructed to discontinue use and seek medical advice if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be advised to stop use and consult a doctor if a cough recurs or is accompanied by a rash or a persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. It is also recommended that patients consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or 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, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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