Daytime Nighttime Cold Flu Relief

Description

This product contains two formulations designed for multi-symptom cold and flu relief: a daytime and a nighttime version, both available in softgel liquid-filled capsules.

The daytime formulation includes acetaminophen (325 mg), dextromethorphan HBr (10 mg), and phenylephrine HCl (5 mg). It serves as a pain reliever and fever reducer, cough suppressant, and nasal decongestant, providing temporary relief from aches, fever, sore throat, cough, and nasal congestion. This formulation is non-drowsy, antihistamine-free, and alcohol-free.

The nighttime formulation contains acetaminophen (325 mg), dextromethorphan HBr (15 mg), and doxylamine succinate (6.25 mg). It functions as a pain reliever and fever reducer, cough suppressant, and antihistamine, offering temporary relief from aches, fever, sore throat, cough, runny nose, and sneezing. This formulation is also alcohol-free.

Both formulations are tamper evident; do not use if the carton is opened or if the blister unit is torn, broken, or shows signs of tampering. For complete warnings and product information, retain the outer carton. This product is distributed by Rite Aid, located at 30 Hunter Lane, Camp Hill, PA 17011.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in adults and children.

Daytime Use It is indicated for the alleviation of the following symptoms:

• Cough due to minor throat and bronchial irritation

• Nasal congestion

• Headache

• Minor aches and pains

• Fever

• Sore throat

Nighttime Use This drug is also indicated for the temporary relief of common cold and flu symptoms during nighttime, including:

• Cough due to minor throat and bronchial irritation

• Sore throat

• Headache

• Minor aches and pains

• Fever

• Runny nose and sneezing

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

Dosage and Administration

For daytime use, adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 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. The product is not recommended for children under 12 years of age.

For nighttime use, adults and children aged 12 years and older should take 2 softgels with water every 6 hours, again adhering to the maximum limit of 4 doses in a 24-hour period. Similar to daytime instructions, the softgels must be swallowed whole and should not be crushed, chewed, or dissolved. This formulation is also not suitable for children under 12 years.

Healthcare professionals should advise patients to follow these guidelines strictly to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of products containing acetaminophen 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 beverages daily while using these products.

Acetaminophen may also lead to 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 physician if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions must be observed to ensure safe use of these products. Patients should not exceed the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Alcoholic beverages should be avoided, as the combination of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving or operating machinery due to the risk of drowsiness.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if redness or swelling occurs, medical advice should be sought. New symptoms, worsening fever lasting more than three days, or a cough that recurs or is accompanied by a rash or headache warrant immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Patients using products containing acetaminophen should be aware of several important warnings and potential adverse reactions.

Severe liver damage 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 these products. In cases of overdose, immediate medical attention is critical; patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly.

In the event of a 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 doctor immediately.

Common adverse reactions may include nervousness, dizziness, or sleeplessness, particularly during daytime use. Patients should also be cautious if pain, cough, or nasal congestion worsens or lasts longer than seven days, or if fever persists for more than three days. Redness or swelling, the emergence of new symptoms, or a cough that returns with a rash or headache lasting longer than usual may indicate a serious condition, warranting medical consultation.

During nighttime use, patients may experience excitability, especially in children, as well as marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery.

Overall, careful adherence to dosing guidelines and awareness of these potential adverse reactions are essential for the safe use of acetaminophen-containing products.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is not recommended in patients currently taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease.

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product to assess potential interactions and the need for monitoring.

Additionally, caution is advised for individuals using sedatives or tranquilizers, as these substances may enhance the sedative effects of this medication. The combined use of alcohol, sedatives, and tranquilizers can significantly increase drowsiness, warranting careful consideration and monitoring of patients' responses.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold 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 not use this product, as it is contraindicated for both Daytime and Nighttime formulations. For patients aged 12 years and older, the recommended dosage for the Daytime formulation is 2 softgels taken with water every 4 hours, while the Nighttime formulation should be taken as 2 softgels with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children using this product. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients indicates that the available data does not suggest any modifications in the use of this medication for geriatric patients. Healthcare providers should continue to exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and overall health status.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using products containing acetaminophen due to the risk of severe liver damage. It is critical that these patients do not exceed a maximum dosage of 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 these products.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. If patients exceed the recommended dosage, they must discontinue use and seek medical advice immediately, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, prompt medical attention is essential; patients should contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 appropriate 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 following an overdose.

Management Procedures

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

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of potential risks related to these aspects remains unaddressed.

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 to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, emphasizing the importance of prompt medical attention 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.

Providers should counsel patients to avoid consuming alcoholic beverages while taking this medication, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness. Additionally, patients should be cautioned to exercise care when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

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 15-30°C (59-86°F) 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

Patients should be informed about the oral route of administration for the medication. For daytime use, adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours, not exceeding 4 doses in a 24-hour period. For nighttime use, the same population should take 2 softgels with water every 6 hours, also not exceeding 4 doses in 24 hours.

Clinicians should counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. Patients must be warned about the risks of overdose, which can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)