Non Drowsy Daytime and Nighttime Cold and Flu

Description

This combination pack contains a total of 40 softgels, comprising 20 non-drowsy daytime cold and flu softgels and 20 nighttime cold and flu softgels. The daytime formulation includes Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; and Phenylephrine HCl, a nasal decongestant. It is indicated for the relief of headache, fever, sore throat, minor aches and pains, nasal congestion, sinus pressure, and cough.

The nighttime formulation also contains Acetaminophen and Dextromethorphan HBr, along with Doxylamine Succinate, an antihistamine. This formulation is designed to relieve headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. The product is comparable to the active ingredients found in Vicks® DayQuil® & NyQuil® Cold & Flu LiquiCaps®†. The National Drug Code (NDC) for this product is 75712-008-40.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates fever, headache, minor aches and pains, cough due to minor throat and bronchial irritation, sore throat, and nasal congestion during daytime use. Additionally, it addresses runny nose and sneezing for nighttime relief.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours during the daytime. For nighttime administration, the same population should take 2 softgels with water every 6 hours. It is important to note that children aged 4 to under 12 years should consult a doctor before use, while the product is not recommended for children under 4 years of age.

In both daytime and nighttime dosing, the total number of doses should not exceed 4 within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. Verify with a healthcare professional if there is uncertainty regarding MAOI content in current medications.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

• Use in children for the purpose of inducing sleep is contraindicated, as it is not intended for this indication.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against taking this product in conjunction with other medications containing acetaminophen, as well as against the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have any of the following conditions: cough with excessive phlegm, liver disease, difficulty urinating due to an enlarged prostate, diabetes, heart disease, thyroid disease, high blood pressure, or persistent or chronic cough associated with smoking, asthma, or emphysema. Specific caution is warranted for patients with breathing problems or chronic coughs that occur at night, as well as those with glaucoma.

Additionally, patients should be advised to consult a doctor or pharmacist before using this product if they are currently taking the blood-thinning medication warfarin or sedatives/tranquilizers, particularly at night.

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

Patients must be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness during the daytime, or if pain, nasal congestion, or cough worsens or persists beyond seven days. For nighttime use, patients should stop taking the product if pain or cough worsens or lasts more than seven days. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs, patients should seek medical advice. New symptoms or a recurrence of cough accompanied by rash or headache that persists should also prompt a consultation, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within 24 hours, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. 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 are advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, individuals should stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness during the daytime, or if pain, nasal congestion, or cough worsens or lasts more than seven days. For nighttime use, patients should be cautious if pain or cough persists beyond seven days, if fever worsens or lasts more than three days, or if redness or swelling is present. New symptoms or a recurrence of cough accompanied by rash or headache that lasts should also prompt consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage to avoid marked drowsiness, particularly during nighttime use. Alcoholic beverages should be avoided, as they may exacerbate drowsiness, especially when combined with sedatives or tranquilizers. Patients should exercise caution when driving or operating machinery due to the potential for excitability, particularly in children.

Before using this product, patients should consult a healthcare professional if they have a cough associated with excessive phlegm, liver disease, difficulty urinating due to an enlarged prostate, diabetes, heart disease, thyroid disease, high blood pressure, or a persistent or chronic cough related to smoking, asthma, or emphysema. For nighttime use, individuals with breathing problems or chronic coughs should also seek medical advice, as should those with glaucoma.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist prior to use. An overdose of this product can lead to serious health complications; therefore, in the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is recommended. Quick medical intervention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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 also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI.

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

Additionally, individuals using sedatives or tranquilizers should seek advice from a healthcare provider before use, particularly if the medication is intended for nighttime use. The combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Non Drowsy Daytime and Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours for daytime use or every 6 hours for nighttime use.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center, as 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 have specific geriatric use information available in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions indicates that the data regarding the use of this medication in geriatric populations is limited.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential age-related physiological changes that may affect drug metabolism and response. Monitoring for efficacy and safety in this population is advised, as the lack of specific guidance necessitates a cautious approach.

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 on 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

Overdose warning is a critical consideration for healthcare professionals when prescribing or advising on medication use. Taking more than the directed dosage can lead to serious health complications.

In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The potential for severe health issues necessitates a proactive approach to managing overdose situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use, which may manifest as skin reddening, blisters, or rash. In such cases, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in children during nighttime use.

Healthcare professionals should be aware of symptoms that may indicate a serious condition, including nervousness, dizziness, or sleeplessness during the daytime; worsening pain, nasal congestion, or cough lasting more than 7 days during the daytime; worsening pain or cough lasting more than 7 days during nighttime; fever persisting or worsening beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product should not be used to induce sleepiness in children.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness during the daytime. They should also be advised to seek medical attention if pain, nasal congestion, or cough worsens or persists for more than seven days. For nighttime use, patients should stop use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, or if redness or swelling occurs. New symptoms should prompt a consultation with a healthcare provider, as should a cough that returns or occurs with a rash or headache lasting longer than usual, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage and to be aware that marked drowsiness may occur with nighttime use. They should avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should also be informed that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery.

Before using this product, patients should consult a doctor if they have a cough accompanied by excessive phlegm, liver disease, difficulty urinating due to an enlarged prostate, diabetes, heart disease, thyroid disease, high blood pressure, or a persistent or chronic cough associated with smoking, asthma, or emphysema. For nighttime use, patients should seek medical advice if they have a breathing problem or chronic cough, glaucoma, or if they are taking blood thinners such as warfarin, sedatives, or tranquilizers.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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