Daytime Nighttime Cold Flu Relief

Description

This product is a multi-symptom cold and flu relief formulation available in softgel dosage form. The daytime formulation contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. It is designed to relieve symptoms such as aches, fever, cough, nasal congestion, and sore throat, and is alcohol-free and antihistamine-free.

The nighttime formulation also contains acetaminophen and dextromethorphan HBr, along with doxylamine succinate, an antihistamine. This combination is intended to relieve aches, fever, cough, sore throat, sneezing, and runny nose. Both formulations are presented in liquid-filled softgels.

The product is 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 CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895.

Uses and Indications

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

During daytime use, it alleviates symptoms including cough due to minor throat and bronchial irritation, nasal congestion, headache, minor aches and pains, fever, and sore throat.

For nighttime use, it provides relief from similar symptoms, specifically targeting 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

For daytime use, adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours, not exceeding 4 doses within a 24-hour period. It is essential to swallow the softgels whole; they should not be crushed, chewed, or dissolved. The use of this 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 ensuring that the total does not exceed 4 doses in a 24-hour period. As with daytime dosing, the softgels must be swallowed whole and should not be crushed, chewed, or dissolved. This product is contraindicated for children under 12 years.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• 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 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 drinks daily while using these products.

Acetaminophen may also cause 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. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage to avoid potential complications. Excitability may occur, particularly in pediatric patients, and marked drowsiness is a possible side effect. Patients are advised to avoid alcoholic beverages, as the combination of alcohol with sedatives or tranquilizers may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the potential for impaired alertness.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should discontinue use and consult a 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 or a worsening fever lasting more than three days, as well as a returning cough accompanied by rash or headache, may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 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 these products. In clinical settings, participants have reported severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients are advised to discontinue use and seek immediate medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

During daytime use, patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or lasts longer than seven days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than three days, or a cough that recurs with a rash or headache, may indicate a serious condition requiring attention.

For nighttime use, patients should be aware that excitability may occur, particularly in children, and marked drowsiness is common. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is advised when driving or operating machinery. Patients should also stop use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever persists beyond three days, or if new symptoms develop.

An overdose warning is pertinent, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Co-administration of this product with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

The use of this product is not recommended 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, and Parkinson’s disease. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional prior to use.

Caution is advised when this product is used in conjunction with warfarin, a blood-thinning medication. Patients should seek medical advice before combining these therapies to ensure appropriate monitoring and dosage adjustments.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness.

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 adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours for the Daytime formulation and every 6 hours for the Nighttime formulation.

Healthcare professionals should be aware that excitability may occur, particularly in children using this product. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific geriatric use information available for this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions pertinent to this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status. Regular monitoring may be advisable to ensure safety and efficacy in this demographic.

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 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 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 absence of guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be aware that these products contain acetaminophen, which poses a risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients must not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Caution is advised against the concurrent use of other medications containing acetaminophen, as this may lead to unintentional overdose.

• Consumption of three or more alcoholic drinks daily while using these products is strongly discouraged due to the increased risk of liver damage.

Before using these products, patients with known liver disease should consult a healthcare professional. Additionally, patients are advised to discontinue use and seek medical advice if they suspect they have taken more than the recommended dose, as this can lead to liver damage. In the event of an overdose, immediate medical attention is essential. This is particularly important for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. 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 potential for liver damage necessitates a high index of suspicion in cases of suspected overdose. Monitoring and supportive care may be required, and specific management protocols should be followed based on the severity of the overdose and the clinical presentation of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Patients should be advised about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients 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 present.

Healthcare providers should instruct patients not to exceed the recommended dosage to minimize the risk of adverse effects. Patients should also be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

It is important to counsel patients to avoid alcoholic beverages while taking this medication, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness. Patients should be cautioned about the potential impairment of their ability to drive a motor vehicle or operate machinery, and they should exercise care in these activities.

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 aged 12 years and older are advised to take 2 softgels with water every 4 hours during the daytime and every 6 hours at nighttime. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is crucial to keep the product out of reach of children.

Patients must be informed of the overdose warning, as exceeding the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, regardless of the presence of symptoms.

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)