Daytime Cold and Flu

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 softgels with water every 4 hours, not to exceed 4 doses within a 24-hour period. It is essential that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

For children under 12 years of age, the use of this product is not recommended.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing and avoid potential overdose.

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, 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.

Additionally, this 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. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, 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 sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

It is critical to adhere to the recommended dosage, as exceeding this can result in liver damage. In the event of an overdose, immediate medical attention is necessary; patients should contact a Poison Control Center at 1-800-222-1222 without delay, as swift intervention is essential for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

While using this product, it is crucial not to exceed the recommended dosage.

Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; symptoms of nervousness, dizziness, or sleeplessness arise; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. 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. In cases of overdose, it is imperative to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients may experience severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is essential to discontinue use and seek medical help without delay.

In instances where a sore throat is severe, 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 also be instructed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days; if nervousness, dizziness, or sleeplessness occurs; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding due to potential pharmacodynamic interactions. Monitoring of coagulation parameters is advisable in such cases to ensure patient safety.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). 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, with a maximum of 4 doses in a 24-hour period. It is important for healthcare professionals to advise patients to read the labels of other Daytime or Nighttime products carefully to ensure correct dosing and avoid potential overdose. In the event of an overdose, prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for 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 drug 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 4,000 mg of acetaminophen in a 24-hour period, take this product in conjunction 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 use. Monitoring of liver function is recommended, particularly in those with compromised liver function, to prevent potential hepatotoxicity.

Patients should be aware that taking more than 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 without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In cases of overdosage, the ingestion of more than the recommended dose may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for serious adverse effects associated with overdose.

Immediate medical assistance is crucial. In the event of an overdose, it is recommended to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as prompt intervention can mitigate the risk of severe complications.

Healthcare providers should be aware that symptoms may not be immediately apparent. Therefore, even in the absence of noticeable signs or symptoms, it is vital to pursue quick medical attention to ensure the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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 be encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should be made aware that they need to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. If fever worsens or lasts more than three days, or if any redness or swelling occurs, patients should also seek medical attention. They should be cautioned to stop use and consult a healthcare provider if new symptoms arise or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is important for healthcare providers to ask patients about their medical history and advise them to consult a doctor before use if they have liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or trouble urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before using this product. Furthermore, patients should be advised to consult a doctor if they have a cough that occurs with excessive phlegm (mucus). Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with their healthcare provider or pharmacist.

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, with adults and children aged 12 years and older instructed to take 2 softgels with water every 4 hours, ensuring they are swallowed whole without crushing, chewing, or dissolving. Use is not recommended for children under 12 years of age.

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

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.

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