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.

Daytime Use It is indicated for the alleviation of the following symptoms:

• Cough due to minor throat and bronchial irritation

• Fever

• Sore throat

• Nasal congestion and sinus pressure

• Headache

• Minor aches and pains

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 exceeding 4 doses within a 24-hour period. It is essential to swallow the softgels whole; they should 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, also adhering to the maximum limit of 4 doses in a 24-hour period. Similar to daytime instructions, the softgels must be swallowed whole and must not be crushed, chewed, or dissolved. This product is contraindicated for children under 12 years.

Healthcare professionals should advise patients to follow these guidelines strictly to avoid the risk of overdose.

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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

Additionally, it is advised not to exceed the recommended dosage and to avoid alcoholic beverages, as alcohol may enhance drowsiness when combined with 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 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 when considering the use of these products. Patients should be advised to seek medical advice prior to 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, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, should also consult a healthcare provider.

Patients should be cautioned to consult a doctor or pharmacist before using these products if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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) or seek emergency medical help right away, regardless of whether signs or symptoms are present.

Patients should discontinue use and contact their 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 advice should be sought. New symptoms or a worsening fever lasting more than three days, as well as a returning cough accompanied by a rash or headache, may indicate a serious condition and warrant immediate medical 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 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.

During daytime use, patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or lasts longer 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. Patients should be vigilant for a cough that recurs or occurs alongside a rash or headache that persists.

For nighttime use, patients should be cautious of worsening pain or cough lasting more than seven days, as well as fever that persists or worsens beyond three days. The presence of redness or swelling, new symptoms, or a recurring cough with associated rash or headache should prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product at night, 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. Patients should exercise caution when driving or operating machinery due to the potential for increased drowsiness.

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 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 pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. Additionally, it is advisable for patients taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

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 4,000 mg of acetaminophen in a 24-hour period.

• Caution is advised against the concurrent use of other medications containing acetaminophen.

• Consumption of three or more alcoholic drinks daily while using these products is not recommended, as it may exacerbate liver damage.

Before using these products, patients with liver disease should consult a healthcare professional. This consultation is particularly important for those considering nighttime use of the product, as liver disease may influence the safety and efficacy of the treatment.

In the event of an overdose, which can lead to liver damage, patients must seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

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

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

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that users discontinue use and seek medical assistance promptly.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 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 apparent.

It is important to emphasize that patients should not exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients are also cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Healthcare providers should instruct patients to exercise 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 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, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently 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 integrity and efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the quality of the product. Proper storage conditions are crucial for ensuring optimal performance and safety.

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, indicating that 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, 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.

View product document (PDF)