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 is specifically 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 to exceed 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, again ensuring that the total does not exceed 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 also not suitable for children under 12 years.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages 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) 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.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Warnings and Precautions

Severe liver damage may occur with the use of products containing acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three alcoholic drinks per day 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, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a severe sore throat. If the sore throat persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

It is crucial to advise patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a healthcare professional. Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be reminded to verify with their healthcare provider or pharmacist if they are unsure about their current medications.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, cough, or nasal congestion worsen or persist 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. Cough that recurs or is accompanied by a rash or persistent headache may indicate a serious condition and should be evaluated promptly.

Side Effects

Severe liver damage may occur in patients taking products containing acetaminophen if they exceed 4,000 mg in 24 hours, 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, 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 doctor 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.

For daytime use, patients should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or lasts more than seven days, or if fever worsens or lasts more than three days, medical consultation is recommended. The presence of redness or swelling, new symptoms, or a cough that returns or occurs with a rash or headache that lasts should also prompt a consultation.

For nighttime use, similar precautions apply. Patients should discontinue 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 is present. New symptoms or a returning cough that occurs with a rash or headache that lasts should also be evaluated by a healthcare professional.

Patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness may be experienced. Alcoholic beverages, sedatives, and tranquilizers may exacerbate drowsiness, and caution is advised when driving or operating machinery.

In cases of overdose, immediate medical attention is critical. 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.

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 patients 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 be at an increased risk for side effects when using this product. However, the prescribing information does not provide specific dosage adjustments or safety considerations for this population. The product is indicated for use in adults and children aged 12 years and older, and there are no specific recommendations or precautions outlined for geriatric patients.

Healthcare providers should remain vigilant when prescribing this product to elderly patients, considering their potential increased sensitivity to adverse effects. Monitoring for any unusual reactions or side effects is advisable in this demographic, even in the absence of specific guidelines.

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 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 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 closely monitored when using products containing acetaminophen due to the risk of severe liver damage. It is critical that these patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit can significantly increase the risk of liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using these products.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional. If any of the following symptoms occur, patients are advised to discontinue use and seek medical advice: worsening pain or cough lasting more than 7 days, fever that worsens or persists for more than 3 days, presence of redness or swelling, emergence of new symptoms, or a cough that returns or occurs with a rash or persistent headache.

In the event of an overdose, which can lead to liver damage, immediate medical attention is essential. Patients should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent. Quick intervention is crucial for both adults and children in cases of acetaminophen overdose.

Overdosage

In cases of overdosage, it is imperative to recognize the potential for serious health consequences, particularly concerning liver damage. Healthcare professionals should be aware that exceeding the recommended dosage can lead to significant adverse effects.

Recommended Actions In the event of an overdose, immediate medical assistance is essential. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of hepatic impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon recognition of an overdose, healthcare professionals should follow established guidelines for the management of such cases. This may include supportive care and monitoring of liver function, as well as considering the need for further interventions based on the clinical presentation. Early recognition and treatment are vital to mitigate the risks associated with overdose.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Patients should be advised 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.

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, patients 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 if they are using 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, as this 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 medication out of reach of children.

Patients must be informed of 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, or the Poison Control Center (1-800-222-1222) should be contacted, 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)