Daytime Cold and Flu

Description

Daytime Cold and Flu is presented in a dosage form of softgels, specifically packaged as 8 softgels per unit. The product is identified by the National Drug Code (NDC) 51013-666-01. It is formulated to contain active ingredients that are comparable to those found in Vicks® DayQuil® Cold & Flu LiquiCaps®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, sore throat, and fever reduction.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours as needed. The total daily dosage must not exceed 8 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere strictly to the recommended dosage to avoid potential adverse effects.

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 components, as this may result in severe hypersensitivity reactions.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Additionally, it is essential not to exceed the recommended dosage when 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 to adhere strictly to the maximum daily dosage of 10 softgels within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

General precautions should be taken for patients with pre-existing conditions. Healthcare providers should recommend that patients consult a physician prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare professional before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience worsening pain or cough lasting more than seven days, fever that worsens or lasts more than three days, redness or swelling, the emergence of new symptoms, or if a cough recurs with a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare professional, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take the product 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 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.

Participants are advised to consult a healthcare professional 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. Additionally, patients should stop use and seek medical advice if pain or cough worsens or lasts longer than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition. Patients may also experience nervousness, dizziness, or sleeplessness, which warrant consultation with a healthcare provider.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough (such as that associated with smoking, asthma, or emphysema) should seek medical advice.

Furthermore, patients taking the blood-thinning medication warfarin are advised to consult a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with other products 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), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide). 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, with a maximum of 8 softgels in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is essential for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are crucial in managing overdose situations effectively.

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 several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt 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 product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, this product is not recommended for children under 12 years of age.

Patients should be instructed to stop using the product and consult a doctor if their pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise, if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition. Furthermore, patients should be advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

When using this product, patients must not exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate gland enlargement, or persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist before using this product.

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, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for optimal performance and safety.

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, as prompt attention is crucial for both adults and children, even in the absence of noticeable 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)