Daytime Nighttime Cold and Flu Relief

Description

The product identified by SPL code 34089-3 is formulated as 01b UC_B-B_Daytime-Nighttime Cold-Flu Relief, containing active ingredients in specific dosages of 80 mg and 40 mg. This formulation is designed to provide relief from cold and flu symptoms, with distinct properties for daytime and nighttime use.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates 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

Patients should take the medication only as directed. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

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.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to stop taking the product and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling develops; new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if patients exceed the maximum recommended dosage of four doses within a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, 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 professional promptly.

Other important considerations include the necessity to stop use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts.

Patients with certain pre-existing conditions should seek medical advice before using this product. These conditions include liver disease, glaucoma, a cough that produces excessive phlegm, breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, as well as difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should consult a doctor or pharmacist prior to use if they are currently taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

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 not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease. This contraindication extends for a period of two weeks following the discontinuation of the MAOI.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as there may be an increased risk of additive central nervous system depression.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be potential interactions that could affect anticoagulation control. Monitoring of INR levels may be warranted 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 aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief.

Caution is advised as 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 not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed 4 doses in a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as well as the consumption of 3 or more alcoholic drinks daily while using this product. Due to the potential for increased risk of liver toxicity, careful consideration of liver function and adherence to dosing guidelines is essential in this patient population.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds four doses within a 24-hour period, which is the maximum daily dosage for this product. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's condition promptly. Monitoring liver function tests and providing supportive care are essential components of management. If necessary, consider the administration of N-acetylcysteine as an antidote for acetaminophen toxicity, following established protocols.

Healthcare professionals should educate patients on the importance of adhering to recommended dosages and the potential risks associated with alcohol consumption and the use of other acetaminophen-containing products.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

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 the importance of prompt attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Healthcare providers should counsel patients to avoid consuming alcoholic beverages while taking this medication, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Additionally, patients should be cautioned to exercise care when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

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 room temperature to maintain its efficacy and integrity. No special handling requirements are necessary beyond standard storage practices.

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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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.

View product document (PDF)