Daytime Cold and Flu

Description

No description information is available.

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, sinus pressure, 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 to avoid the risk of 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 prior to ingestion.

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

When utilizing other Daytime or Nighttime products, it is essential to read each label carefully to ensure proper dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

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 typically 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, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice 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 taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center (1-800-222-1222) 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 discontinue use and contact a healthcare professional if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; symptoms of nervousness, dizziness, or sleeplessness; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting longer than expected. 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 with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical; patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent.

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 must discontinue use and seek medical assistance promptly.

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 healthcare provider immediately.

Patients are advised to stop use and consult a doctor 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 longer than expected. These symptoms could indicate a serious underlying condition.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. Caution is advised in these situations to mitigate the risk of hepatotoxicity.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. It is recommended to avoid the use of dextromethorphan in conjunction with MAOIs or for a period of two weeks following the discontinuation of MAOIs to prevent potential interactions.

Warfarin, an anticoagulant, may have its therapeutic effects modified when administered with acetaminophen. Therefore, it is essential to monitor International Normalized Ratio (INR) levels closely in patients receiving both warfarin and acetaminophen 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

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 be closely monitored due to the potential for severe liver damage associated with the use of 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 alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention 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 recognize the seriousness of an overdose and act swiftly.

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. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate potential complications associated with liver damage.

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

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include 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 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. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or persists for more than 7 days; nervousness, dizziness, or sleeplessness develops; fever worsens or lasts more than 3 days; redness or swelling appears; new symptoms arise; or if a cough returns or occurs alongside a rash or headache that lasts.

Before initiating treatment, patients should be encouraged 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, a persistent or chronic cough associated with smoking, asthma, or emphysema, or a cough that produces excessive phlegm (mucus).

Additionally, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

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 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

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)