Night Time Cold and Flu Relief

Description

This product is a multi-symptom nighttime cold and flu relief formulation, containing acetaminophen (325 mg) as a pain reliever and fever reducer, dextromethorphan HBr (15 mg) as a cough suppressant, and doxylamine succinate (6.25 mg) as an antihistamine. It is designed to alleviate symptoms such as aches, fever, sore throat, cough, runny nose, and sneezing. The formulation is alcohol-free and is not manufactured or distributed by The Procter & Gamble Company; Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company. The product is tamper evident; do not use if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering. For complete warnings and product information, retain the outer carton. Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 softgels with water every 6 hours, not to exceed 4 doses within a 24-hour period. It is essential that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

For children under 12 years of age, the use of this product is not recommended.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication 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.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about whether a prescription medication contains an MAOI, it is essential to seek guidance from a healthcare professional prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications containing acetaminophen or consume three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Healthcare professionals must emphasize the importance of adhering to the recommended dosage, as exceeding this can lead to liver damage. In instances of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should also be instructed to stop using the product and consult a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling develops; new symptoms arise; or if a cough recurs alongside a rash or headache that lasts. 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 with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially present.

Patients should also be alert for severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance promptly. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider without delay.

While using this product, excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms could 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) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to use to assess the need for monitoring or dosage adjustments.

Furthermore, the concomitant use of this medication with sedatives or tranquilizers should be approached with caution. Patients are advised to seek guidance from a healthcare provider before combining these agents, as the combination may enhance drowsiness. Alcohol, sedatives, and tranquilizers can further exacerbate this effect, increasing the risk of sedation and impairment.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. Due to the risk of overdose and subsequent liver damage, patients must adhere strictly to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication can lead to significant liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing necessary interventions.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly improve outcomes in cases of overdose.

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 identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be informed that excitability may occur, particularly in children, and they should be cautious about engaging in activities that require full alertness. Marked drowsiness is a potential side effect, and patients should be warned that the use of alcohol, sedatives, and tranquilizers can exacerbate this drowsiness. Therefore, it is advisable for patients to avoid alcoholic beverages while taking this medication.

Additionally, healthcare providers should emphasize the importance of exercising caution when driving a motor vehicle or operating machinery due to the risk of drowsiness and impaired coordination.

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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)