Severe Nighttime Cold and Flu Relief

Description

NDC 11822-0677-8. This product is formulated to provide maximum strength relief for severe nighttime cold and flu symptoms. It contains the following active ingredients: Dextromethorphan HBr, a cough suppressant; Diphenhydramine succinate, an antihistamine; and Phenylephrine HCl, a nasal decongestant. The formulation is designed to alleviate headache, fever, sore throat, minor aches and pains, nasal and sinus congestion, sinus pressure, sneezing, runny nose, and cough. The product is presented in the form of 24 caplets.

The packaging is tamper-evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® NyQuil® VapoCOOL® SEVERE COLD & FLU + CONGESTION. Distributed by Rite Aid, 200 Newberry Commons, Etters, PA 17319. For more information, visit www.riteaid.com.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough. Additionally, it aids in reducing coughing to facilitate sleep, addresses runny nose and sneezing, and mitigates cough due to minor throat and bronchial irritation.

This medication also reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

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) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare provider if their current medications include an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as blisters, rash, or skin reddening. 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 sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, difficulty urinating due to prostate enlargement, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a healthcare provider if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients are advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs with a rash or headache lasting longer than usual, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include significant liver damage, which may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions characterized by blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious of a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery due to the potential for increased drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Drug Interactions

Co-administration 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 or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients should consult with a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as this may enhance sedative effects and increase the risk of respiratory depression.

Furthermore, individuals on the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding due to potential interactions. Monitoring of INR levels may be warranted in such cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. It is essential for both adults and pediatric patients to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information available 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 should consult a healthcare professional prior to use. Special monitoring may be required for these individuals, as dosage adjustments may be necessary based on their level of renal function. Additionally, renal function tests should be considered for patients with kidney problems to ensure appropriate management and dosing.

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. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. Reports have included instances of blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Healthcare providers should caution patients about the increased risk of drowsiness when consuming alcohol, sedatives, or tranquilizers in conjunction with this medication. Patients should be advised to avoid alcoholic beverages entirely while taking this medication.

Additionally, patients should be made aware of the need for caution when driving a motor vehicle or operating machinery, as drowsiness may impair their ability to perform these tasks safely.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)