Daytime Cold and Flu

Description

SPL code 34089-3 corresponds to a formulation indicated for the management of symptoms associated with daytime cold and flu. This product is designed to alleviate discomfort while allowing for continued daily activities.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours as needed.

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

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

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. This is to prevent the risk of acetaminophen overdose, which can lead to severe liver damage.

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 commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. The combination may lead to serious drug interactions.

Patients are also advised not to exceed the recommended dosage while using this product to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed four doses within a 24-hour period, which is the maximum daily amount when combined with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Patients should be cautioned regarding the potential severity of sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative that they seek medical attention promptly.

Before initiating treatment, it is essential for healthcare providers to inquire about the patient's medical history. Patients should be advised to consult a physician prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients with a cough that produces excessive phlegm should also seek medical advice before use. It is particularly important to consult a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days accompanied by redness or swelling, medical advice should be sought. New or returning symptoms, particularly a cough that recurs or is associated with a rash or headache, may indicate a serious condition and warrant immediate evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions.

Severe liver damage may occur if patients exceed the maximum recommended dosage of four doses within a 24-hour period, especially when combined with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Patients experiencing a severe sore throat that lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should seek medical attention promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include feelings of nervousness, dizziness, or sleeplessness. Patients should also stop use if symptoms worsen or persist beyond five days for children or seven days for adults. If fever worsens or lasts more than three days, particularly with accompanying redness or swelling, medical advice should be sought. New symptoms or a recurrence of cough, especially if associated with a rash or persistent headache, may indicate a serious condition and require immediate medical evaluation.

Before using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or a cough that produces excessive phlegm should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of MAOI therapy. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg). 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 medication is not recommended for children under 4 years of age.

In pediatric patients, if symptoms worsen or persist for more than 5 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. For adults, symptoms lasting more than 7 days also warrant consultation.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product, including any other medications that may also contain acetaminophen.

Additionally, patients who consume 3 or more alcoholic drinks daily are at an increased risk of severe liver damage while using this product. Therefore, it is advised that patients with compromised liver function consult a healthcare professional prior to use.

Patients with liver disease should seek medical advice before using this product to ensure safety and appropriate management of their condition. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals recognize the importance of prompt intervention in cases of overdosage.

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 for guidance. Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate potential health risks associated with overdosage.

Nonclinical Toxicology

The available nonclinical data indicates that there are no specific findings related to teratogenic effects. However, it is advised to consult a health professional prior to use. Similarly, there are no documented non-teratogenic effects, and individuals are also encouraged to seek professional guidance before use.

No additional information is provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as skin rash, itching, and hives. Instances of liver injury have been noted, including cases of acute liver failure. Gastrointestinal bleeding has also been reported.

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Cardiovascular events, such as hypertension and arrhythmias, have been observed. Neurological events, including seizures and confusion, have been reported as well. Additionally, respiratory events, including bronchospasm and respiratory depression, have been identified.

Patient Counseling

Healthcare providers should advise patients that taking more than the directed dosage of this medication can lead to serious health problems. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, or for two weeks after discontinuing MAOI medications. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to stop using the medication and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to seek medical advice if their symptoms worsen or persist beyond five days for children or seven days for adults. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also be instructed to stop use and contact a healthcare provider.

Patients should be made aware that new symptoms may arise, and they should seek medical advice if a cough returns or occurs alongside a rash or persistent headache, as these could indicate a serious condition.

While using this product, patients must be reminded to adhere strictly to the directed dosage. It is advisable for patients to consult a doctor before using this medication if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema, or if they have a cough that produces excessive phlegm.

Lastly, patients should be encouraged to speak with a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin.

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, maintaining a range of 20-25 °C (68-77 °F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. Patients should be informed that exceeding the recommended dosage can lead to serious health issues. 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 Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)