Daytime Nighttime Cold Flu Relief

Description

No description information is available for the drug.

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 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 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 and should not be crushed, chewed, or dissolved. 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. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate risks associated with acetaminophen use:

Liver Warning Patients must not exceed 4,000 mg of acetaminophen within a 24-hour period. Caution is advised when using other medications that also contain acetaminophen, as this can lead to unintentional overdose. Additionally, consumption of three or more alcoholic drinks daily while using these products significantly increases the risk of liver damage.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are instructed to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists beyond two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General Precautions Healthcare professionals should emphasize the importance of adhering to the recommended dosage to prevent overdose, which can result in liver damage. In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent.

Emergency Medical Help Patients must be informed to seek emergency medical help if they experience any skin reactions, as these may indicate a serious condition.

When to Contact a Doctor Patients should be advised to stop taking the medication and consult their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, if redness or swelling occurs, if new symptoms develop, or if fever worsens or lasts more than three days. A return of cough accompanied by rash or headache that persists should also prompt immediate medical evaluation, as these may be indicative of a serious underlying condition.

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 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.

Participants should discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness during daytime use, or if pain, cough, and nasal congestion worsen or last longer than seven days. Additionally, the presence of redness or swelling, the emergence of new symptoms, or a fever that worsens or lasts more than three days warrants medical consultation. For nighttime use, similar precautions apply; worsening pain or cough lasting more than seven days, persistent fever, redness or swelling, new symptoms, or a cough that recurs with a rash or headache should prompt patients to seek medical attention.

When using this product, particularly at night, patients may experience excitability, especially in children, and marked drowsiness. It is advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving or operating machinery due to the potential for increased drowsiness.

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. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 either the Daytime or Nighttime formulations. Caution is advised as excitability may occur, particularly with the Nighttime formulation. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations based on the available data. However, healthcare providers should remain vigilant when prescribing to this population, as individual responses to treatment can vary. It is advisable to monitor geriatric patients closely for any potential adverse effects or changes in efficacy, given the general physiological changes associated with aging.

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 the safety of both the mother 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 patients with reduced kidney function, as the absence of detailed 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 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.

• Caution is advised against the concurrent use of other medications containing acetaminophen, as this may 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-related risks.

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 any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; or the emergence of new symptoms.

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. It is imperative that healthcare professionals recognize the seriousness of an overdose and act swiftly.

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 for guidance. Prompt intervention is crucial, as symptoms may not be immediately apparent in both adults and children. Therefore, even in the absence of noticeable signs or symptoms, it is essential to pursue medical evaluation and treatment without delay.

The management of an overdose will depend on the specific circumstances and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any complications that arise from liver damage.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies, and there was no increase in fetal malformations observed. However, studies in animals have demonstrated that acetaminophen can cause liver damage at high doses. Additionally, acetaminophen has been associated with adverse developmental outcomes when administered at doses significantly higher than the recommended human dose.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 the importance of prompt attention 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.

Healthcare providers should counsel patients to avoid alcoholic beverages, as the combination of alcohol with this medication can exacerbate drowsiness. Additionally, patients should be made aware that the use of sedatives and tranquilizers may further increase drowsiness.

Finally, patients should be cautioned about the risks associated with driving a motor vehicle or operating machinery while taking this medication, 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 15-30°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

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 important to inform patients about the overdose warning, 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, 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.

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