Daytime Nighttime Cold Flu Relief

Description

No description information is available.

Uses and Indications

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

For daytime use, it alleviates the following symptoms: cough due to minor throat and bronchial irritation, fever, sore throat, nasal congestion and sinus pressure, headache, and minor aches and pains.

For nighttime use, it addresses 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 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. Similar to 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:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated 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 whether a prescription medication contains an MAOI, 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.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, cough associated with excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Additionally, patients with persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice prior to use.

Patients should also consult a doctor or pharmacist before using these products if they are taking blood-thinning medications such as warfarin or if they are using sedatives or tranquilizers.

In the event of an 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 signs or symptoms.

Patients are advised to discontinue use and contact 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 consultation is necessary. New symptoms or a worsening fever lasting more than three days should also prompt a call to a healthcare professional. If a cough recurs or is accompanied by a rash or headache that persists, these 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.

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

In clinical practice, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider 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 more than seven days, or if redness or swelling is present, medical advice should be sought. New symptoms or a fever that worsens or lasts more than three days also warrant consultation. A cough that recurs or occurs with a rash or headache lasting longer than expected should be evaluated by a healthcare professional.

During nighttime use, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for increased sedation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 adolescents 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.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or have unique safety concerns as per the available data. However, it is essential for healthcare providers to consider general health conditions that may affect the use of this medication in geriatric patients.

Before initiating treatment, it is advisable for elderly patients to consult a healthcare professional 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, particularly for daytime use. For nighttime use, patients should also seek medical advice if they have liver disease or respiratory issues, including chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Caution is warranted regarding the concomitant use of alcohol, sedatives, and tranquilizers, as these substances may enhance drowsiness, posing a potential risk for elderly patients. Additionally, it is critical to inform geriatric patients about the risks associated with overdose, as exceeding the recommended dosage can lead to liver damage, a significant concern in this population. Regular monitoring and careful management of these factors are recommended to ensure the safety and efficacy of treatment in elderly patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 be aware that these products contain acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using these products.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event that patients exceed the recommended dosage, they should discontinue use and seek medical advice immediately, as taking more than the recommended dose can lead to liver damage. In cases of overdose, it is imperative to obtain medical assistance or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Exceeding the recommended dosage of the medication can lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as the effects of an overdose may not be immediately apparent.

Both adults and children are at risk, and it is essential to seek quick medical attention even in the absence of noticeable symptoms. Early recognition and management of an overdose can significantly improve outcomes and mitigate potential complications.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert text.

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, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important to inform them that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

When discussing safety, healthcare providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider before using the medication 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, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

For nighttime use, patients should be advised to consult a healthcare provider if they have liver disease, glaucoma, a cough with excessive phlegm, a breathing problem or chronic cough (such as occurs with smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should be instructed to ask a doctor or pharmacist before using the medication if they are taking the blood-thinning drug warfarin, whether during the day or at night, or if they are using sedatives or tranquilizers at night.

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

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 not to exceed the recommended dosage during both daytime and nighttime use. Notably, excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients are cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Additionally, care should be taken when driving or operating machinery due to the sedative effects.

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.

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