Daytime Nighttime Cold Flu Relief

Description

This product contains active ingredients comparable to those found in Vicks® Dayquil® and Nyquil® Cold & Flu LiquiCap®† formulations. The Daytime formulation is designed for multi-symptom cold and flu relief, featuring acetaminophen as a pain reliever and fever reducer, dextromethorphan HBr as a cough suppressant, and phenylephrine HCl as a nasal decongestant. It effectively alleviates major cold and flu symptoms, including aches and fever, sore throat, coughing, and congestion. The dosage form is softgels.

The Nighttime formulation also provides multi-symptom cold and flu relief, utilizing acetaminophen for pain relief and fever reduction, dextromethorphan HBr for cough suppression, and doxylamine succinate as an antihistamine. This formulation is intended to relieve cold and flu symptoms to facilitate rest, and it is also presented in softgel form.

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. Users are advised to carefully read the labeling for correct dosing when using both Daytime and Nighttime products. This product is distributed by Foodhold U.S.A., LLC, located in Landover, MD 20785, and can be contacted at 1-877-846-9949.

†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.

Uses and Indications

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

Daytime Use: It provides relief from cough due to minor throat and bronchial irritation, nasal congestion, headache, minor aches and pains, fever, and sore throat.

Nighttime Use: It alleviates similar symptoms, including 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 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. As with daytime dosing, the softgels should be swallowed whole and must 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:

• 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, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using these products.

Acetaminophen may also induce 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 be vigilant regarding sore throat symptoms. 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 physician is advised.

Overdose of acetaminophen can lead to significant liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center without delay, as rapid intervention is critical for both adults and children, even in the absence of overt symptoms.

Emergency medical help should be sought if any skin reactions occur.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following symptoms during the daytime: nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than seven days; presence of redness or swelling; emergence of new symptoms; or if fever worsens or persists beyond three days.

During nighttime, patients should also stop taking the product and contact their doctor if they experience worsening pain or cough lasting more than seven days, worsening fever lasting more than three days, presence of redness or swelling, emergence of new symptoms, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires 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.

Patients should be aware that acetaminophen may 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 and seek medical assistance immediately.

In clinical settings, 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 professional promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness during daytime use. Additionally, if pain, cough, or nasal congestion worsens or lasts longer than seven days, or if redness or swelling is observed, medical advice should be sought. New symptoms or a fever that worsens or lasts more than three days also warrant consultation.

For nighttime use, patients should 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, or if redness or swelling occurs. The emergence of new symptoms or a cough that recurs with a rash or headache lasting longer than a specified duration should also prompt a consultation, as these may indicate a serious underlying condition.

Drug Interactions

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

The use of this product is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and should be avoided for at least 2 weeks after discontinuation of the MAOI.

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

Additionally, the concomitant 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 medication. For patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours for Daytime use and every 6 hours for Nighttime use.

Caution is advised as excitability may occur, particularly in children. It is essential to keep this medication out of reach of children. Quick medical attention is critical for both adults and pediatric patients, even if no signs or symptoms are immediately noticeable.

Geriatric Use

Elderly patients may not require specific dosage adjustments or present unique safety concerns based on the available data. However, it is essential for healthcare providers to consider general precautions when prescribing this medication to geriatric patients.

Before initiating treatment, it is advisable for elderly patients to consult with their healthcare provider if they have a history of liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or urinary difficulties due to an enlarged prostate gland. Adherence to the recommended dosage is crucial, as exceeding this may lead to adverse effects.

Elderly patients should be made aware that marked drowsiness may occur with the use of this product. Therefore, it is recommended to avoid the consumption of alcoholic beverages, as well as the use of sedatives and tranquilizers, which may exacerbate drowsiness. Caution is advised when driving or operating machinery due to the potential for impaired alertness. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure safety and efficacy.

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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

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

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, they should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage.

• Consumption of three or more alcoholic drinks daily while using these products is not recommended, as it may exacerbate liver function impairment and increase the likelihood of severe liver damage.

Before using these products, patients with liver disease should consult a healthcare professional. It is essential to monitor for any worsening of symptoms, such as pain, cough, or nasal congestion, which should prompt immediate medical consultation if they persist beyond seven days.

In the event of an overdose, which can lead to liver damage, patients must seek medical assistance or contact a Poison Control Center immediately. 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 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

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage can lead to serious liver damage. In the event of an overdose, patients must be instructed to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is essential to counsel patients to avoid alcoholic beverages, as the consumption of alcohol, sedatives, and tranquilizers can significantly enhance drowsiness.

Additionally, healthcare providers should remind patients to exercise caution when driving or operating machinery, as drowsiness may impair their ability to perform these tasks safely.

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° to 30°C (59° to 86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which 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

Adults and children aged 12 years and over are advised to take 2 softgels with water every 4 hours for Daytime use and every 6 hours for Nighttime use. 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. An overdose warning is in place, as exceeding the recommended dose may lead to liver damage; in such cases, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)