Daytime Nighttime Cold and Flu Relief

Description

Acetaminophen 325 mg, dextromethorphan HBr 10 mg, and phenylephrine HCl 5 mg are the active ingredients in this formulation. The product serves multiple therapeutic purposes, functioning as a pain reliever and fever reducer, cough suppressant, and nasal decongestant. It is formulated as softgels, which are liquid-filled capsules, and is characterized as alcohol-free and antihistamine-free.

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

• Nasal congestion

• Headache

• Minor aches and pains

• Fever

• Sore throat

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, 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 these guidelines 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This is due to potential interactions that may exacerbate side effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• Exceeding the recommended dosage is contraindicated to prevent adverse effects.

• Consumption of alcoholic beverages is contraindicated, as it may increase the risk of drowsiness and other side effects.

• The combination of alcohol, sedatives, and tranquilizers is contraindicated due to the potential for increased drowsiness.

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 this product.

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 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, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin or any sedatives or tranquilizers.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to 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 symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond seven days; if redness or swelling occurs; if new symptoms develop; if fever worsens or lasts more than three days; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires 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 this product.

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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness during daytime use. Additionally, if pain, cough, or nasal congestion worsens or lasts longer than seven days, or if redness or swelling is observed, medical advice should be sought. New symptoms or a fever that worsens or lasts more than three days also warrant consultation. For nighttime use, similar precautions apply; worsening pain or cough lasting more than seven days, persistent fever, or the emergence of new symptoms should prompt a visit to a healthcare provider.

While using this product, particularly at night, patients may experience excitability, especially 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 or operating machinery due to the potential for increased drowsiness.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Caution is advised when consuming alcohol, sedatives, or tranquilizers in conjunction with this medication, as these substances may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation and potential respiratory depression is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold and 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 during the daytime and every 6 hours at nighttime.

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

Elderly patients may not require specific dosage adjustments or safety considerations when using this product, as no geriatric use information is provided in the prescribing information. The product is indicated for adults and children aged 12 years and older.

However, it is essential for healthcare providers to exercise caution when prescribing this product to geriatric patients, particularly those with underlying health conditions. Patients should be advised to consult a physician prior to use if they have liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or experience difficulty urinating due to an enlarged prostate gland (for daytime use). Additionally, for nighttime use, patients should seek medical advice if they have liver disease, glaucoma, or a history of breathing problems or chronic cough.

Furthermore, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which poses a particular risk for elderly patients. Monitoring for increased sedation and potential adverse effects is recommended in this population to ensure their safety and well-being.

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 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 lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of this product, particularly due to the presence of acetaminophen. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, combine this product with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to using this product. Monitoring for any worsening of pain or cough is essential; if symptoms persist for more than seven days, patients should discontinue use and seek medical advice.

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 at 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 remain vigilant regarding the potential for overdose, as the consequences can be severe.

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. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of proactive management even in the absence of observable signs or symptoms of overdose.

Prompt recognition and treatment of an overdose can significantly improve outcomes, making it essential for healthcare professionals to act swiftly and decisively in these situations.

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 identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to adhere strictly to the recommended dosage, as exceeding this can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is important to counsel patients to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers can significantly enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for impaired alertness.

Healthcare providers should encourage patients to consult with a doctor before using this 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, 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 if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers, as these may interact with the medication.

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). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Daytime Nighttime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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