Daytime Cold and Flu

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, 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

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. 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 four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each product label to confirm appropriate dosing and avoid exceeding the maximum dosage.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• Exceeding the recommended dosage is also contraindicated, as it may lead to increased risk of 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 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

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 advised to consult a physician without delay.

General precautions should be taken when considering the use of this product. Patients are encouraged to consult a healthcare provider prior to use 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 with a cough that produces excessive phlegm should seek medical advice before use. It is also important to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting beyond a reasonable duration. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

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

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical help immediately.

In addition, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a doctor promptly.

Patients are encouraged to stop use and consult a healthcare professional if they notice any of the following: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or lasts more than three days; redness or swelling; new symptoms; or a cough that returns or occurs with a rash or headache lasting for an extended period. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily. It is advisable for patients to avoid such combinations to mitigate the risk of hepatotoxicity.

Dextromethorphan is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing MAOI therapy due to the risk of severe interactions. Patients should be counseled to refrain from using dextromethorphan in conjunction with MAOIs to prevent serious adverse effects.

Patients on warfarin therapy should seek medical advice prior to using products containing acetaminophen, as it may influence International Normalized Ratio (INR) levels. Monitoring of INR is recommended to ensure safe and effective anticoagulation management.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hbr, 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, with a maximum of 4 doses within a 24-hour period.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 on 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit can lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

Before initiating treatment, patients with known liver disease should consult a healthcare professional. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

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.

Quick medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Healthcare providers should emphasize the importance of prompt action to mitigate potential risks associated with overdose.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days. Additionally, they should stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. If fever worsens or lasts longer than 3 days, or if any redness or swelling occurs, patients should also consult a healthcare professional. New symptoms that arise during treatment should prompt a discussion with a doctor, as should a cough that returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

It is important for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty 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 prior to use. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist before proceeding.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30ºC (59-86ºF) to maintain its integrity and efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the quality of the product. Proper storage conditions are crucial for ensuring optimal performance and safety.

Additional Clinical Information

No further data are available.

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)