Daytime Nighttime Cold Flu Relief

Description

This product is a multi-symptom cold and flu relief formulation available in two distinct formulations: daytime and nighttime. The daytime softgels are designed to provide non-drowsy relief from symptoms including aches, fever, sore throat, nasal congestion, and cough. The active ingredients in the daytime formulation include acetaminophen, which serves as an analgesic and antipyretic, dextromethorphan HBr, a cough suppressant, and phenylephrine HCl, a nasal decongestant. These softgels are alcohol-free and antihistamine-free.

The nighttime softgels are formulated to address similar symptoms but include doxylamine succinate, an antihistamine, to aid in sleep. This formulation also contains acetaminophen and dextromethorphan HBr, providing relief from aches, fever, sore throat, cough, sneezing, and runny nose. Both formulations are presented in liquid-filled capsules.

This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, 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 signs of tampering. For complete warnings and product information, keep the outer carton. Distributed by Supervalu Inc., Eden Prairie, MN 55344 USA. For more information, visit supervaluprivatebrands.com.

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 specifically 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 and not 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 adhering to the maximum limit of 4 doses in a 24-hour period. As with daytime dosing, the softgels must be swallowed whole without crushing, chewing, or dissolving. This product is also not suitable for children under 12 years.

Healthcare professionals should advise patients to follow these guidelines closely 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 beverages daily while using these products.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding patients presenting with a severe sore throat that persists for more than two days, particularly if accompanied by fever, headache, rash, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Overdose of acetaminophen can lead to significant liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of overt symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, cough, or nasal congestion lasting more than seven days

• Presence of redness or swelling

• Onset of new symptoms

• Fever that worsens or persists beyond three days

• Recurrence of cough, particularly if accompanied by rash or a headache that lasts

Similar precautions apply during nighttime use, where patients should seek medical advice if pain or cough worsens or lasts beyond seven days, fever persists or worsens beyond three days, redness or swelling is noted, new symptoms arise, or if cough recurs with associated rash or headache.

These symptoms may indicate a serious underlying condition that requires further evaluation and management.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, take other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using these products. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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.

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.

When using this product, it is crucial for patients to adhere to the recommended dosage. During daytime use, patients should be cautious of potential nervousness, dizziness, or sleeplessness. If pain, cough, or nasal congestion worsens or lasts longer than seven days, or if new symptoms arise, patients should seek medical advice. Additionally, if fever worsens or persists beyond three days, or if cough recurs with a rash or headache that lasts, medical consultation is advised.

For nighttime use, patients may experience excitability, particularly in children, as well as marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery. If pain or cough worsens or lasts more than seven days, or if fever persists beyond three days, patients should consult a doctor. New symptoms, redness, or swelling should also prompt medical evaluation.

An overdose warning is in place, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 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 used for at least 2 weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product, as there may be an increased risk of bleeding.

Caution is advised when using this product in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and sedation effects. Monitoring for increased sedation is recommended in such cases.

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, as both the Daytime and Nighttime formulations are contraindicated in this age group. 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 pediatric patients using the Nighttime formulation. Additionally, an overdose warning is applicable; prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face 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 difficulty urinating 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of products containing 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 that also contain acetaminophen, or consume three or more alcoholic drinks daily while using these products.

It is advised that patients with a history of liver disease consult a healthcare professional prior to using these products. Monitoring for signs of worsening conditions is essential; patients should discontinue use and seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical 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 medical assistance immediately. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can be vital in mitigating potential harm and ensuring appropriate management of the situation.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the area of animal pharmacology and 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 to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) 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. Providers should recommend that patients avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be cautioned about the risks associated with driving a motor vehicle or operating machinery while taking this medication.

Healthcare providers should encourage patients to consult with a doctor before use if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, a cough that produces excessive phlegm (mucus), or difficulty urinating due to an enlarged prostate gland. Additionally, patients with glaucoma, breathing problems, or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should be advised to consult with a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

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

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.

Patients should be informed about the risks of overdose, as exceeding the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is crucial 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)