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:

• Fever

• Cough due to minor throat and bronchial irritation

• Minor aches and pains

• Nasal congestion and sinus pressure

• Headache

• Sore throat

Nighttime Use This drug is also indicated for the temporary relief of 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 no more than 4 doses are taken 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:

• 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) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious drug interactions. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

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 promptly if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions must be observed to ensure safe use of these products. Patients should not exceed the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the risk of drowsiness.

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

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, worsening fever lasting more than three days, or a cough that recurs with a rash or headache warrant immediate medical evaluation, as these may indicate a serious 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.

In clinical practice, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Patients are advised to stop 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 present, medical advice should be sought. New symptoms or a fever that worsens or lasts more than three days also warrant consultation. A cough that recurs or occurs with a rash or headache lasting beyond a few days could indicate a serious condition.

During nighttime use, patients may experience excitability, particularly in children, as well as marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for increased sedation.

Drug Interactions

Acetaminophen has several notable drug interactions that warrant careful consideration.

Pharmacodynamic Interactions

Acetaminophen may increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advisable to avoid the concomitant use of multiple acetaminophen-containing products and to limit alcohol intake to reduce the risk of hepatotoxicity.

Pharmacokinetic Interactions

The use of acetaminophen in conjunction with prescription monoamine oxidase inhibitors (MAOIs) can result in serious interactions. It is recommended to avoid acetaminophen during MAOI therapy and for at least two weeks following the cessation of MAOI treatment to prevent adverse effects.

Additionally, acetaminophen may alter the anticoagulant effects of warfarin. Therefore, it is essential to monitor International Normalized Ratio (INR) levels in patients taking both acetaminophen and warfarin to ensure safe and effective anticoagulation management.

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

Elderly patients may not require specific dosage adjustments or safety considerations based on the available data. However, healthcare providers should remain vigilant when prescribing medications to this population, as individual responses may vary. It is advisable to monitor elderly 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. It is important to assess the potential risks and benefits associated with its 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 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 the risk of liver damage.

Before using these products, patients with liver disease should consult a healthcare professional.

Patients are advised to discontinue use and seek medical advice if symptoms such as pain, cough, or nasal congestion worsen or persist for more than seven days.

In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought. Patients should 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 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

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented, with potential for liver damage resulting from the ingestion of doses exceeding the recommended amount. In instances of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent. It is recommended to contact a Poison Control Center (1-800-222-1222) for guidance.

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.

Patients should exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Healthcare providers should encourage patients to consult a doctor 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 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 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.

Patients should 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, 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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