Daytime Nighttime Cold Flu Relief

Description

No description information is available for the specified drug.

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 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:

The product should not be used in conjunction 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) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. If there is any doubt about whether a prescription medication contains an MAOI, it is essential to seek guidance from a healthcare professional prior to using this product.

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 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 advise patients to consult a doctor promptly 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.

It is crucial to emphasize that taking more than the recommended dose of acetaminophen can lead to liver damage. In cases of suspected overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to stop taking the medication 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 for more than three days. Similar guidance applies during nighttime, where patients should seek medical advice if pain or cough worsens or lasts beyond seven days, fever persists or worsens for more than three days, redness or swelling is observed, new symptoms arise, or if cough recurs with a rash or headache that lasts.

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, 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 any of the following symptoms: nervousness, dizziness, or sleeplessness during daytime use; 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 lasts more than three days. Similar precautions apply to nighttime use, where worsening pain or cough, persistent fever, redness or swelling, new symptoms, or recurrence of cough with rash or headache lasting should prompt consultation with a doctor.

During nighttime use, patients may experience excitability, particularly 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.

An overdose of acetaminophen can lead to liver damage. Patients are urged to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if an overdose is suspected, 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 acetaminophen with other medications containing acetaminophen is contraindicated due to the risk of severe liver damage. Patients are advised to avoid such combinations.

The use of monoamine oxidase inhibitors (MAOIs) is contraindicated with this product. Patients should not take this product if they are currently on MAOIs or have discontinued them within the past two weeks.

Patients who are on warfarin should consult their healthcare provider prior to using this product, as there may be interactions that could affect anticoagulation and blood thinning.

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

No additional drug interactions or laboratory test interactions have been identified.

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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

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 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 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, nor should they use these products in conjunction with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using these products may further increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using these products. Monitoring for any worsening of symptoms is essential; patients should discontinue use and seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days.

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 crucial 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 advise patients to seek immediate medical assistance in the event of an overdose. This includes contacting a Poison Control Center at 1-800-222-1222 without delay.

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 or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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. It is important to inform them that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Providers should caution patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

When discussing safety, healthcare providers should remind patients to exercise caution when driving or operating machinery due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider 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, or difficulty urinating due to an enlarged prostate gland. Additionally, patients with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor before use if they have glaucoma, a breathing problem, or chronic cough, as well as if they are taking the blood-thinning medication warfarin or any 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 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 product remains effective and safe for use.

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 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 the event of an overdose, patients should seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential 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.

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