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 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 should 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 label to confirm appropriate dosing and avoid exceeding the maximum dosage.

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. 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 carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor 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 experiencing a cough with excessive phlegm should seek medical advice. It is also crucial to inquire about the use of warfarin, a blood-thinning medication, as it may interact with acetaminophen.

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

Monitoring and Follow-Up Patients should be advised to discontinue use and contact a 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 persisting beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache. 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.

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.

In cases 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 discontinue 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 persists for more than three days; if redness or swelling is observed; if new symptoms develop; or if a cough recurs or occurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Additionally, taking more than the recommended dose of acetaminophen can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. Co-administration of these agents can potentially alter the anticoagulant effect of warfarin, leading to an increased risk of bleeding.

It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are currently taking warfarin. Monitoring of INR (International Normalized Ratio) levels may be warranted to ensure safe and effective anticoagulation therapy.

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. Care should be taken to adhere to the dosing guidelines to avoid potential overdose.

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 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 regarding the excretion of this medication 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 important to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that 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.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. Due to the potential for overdose and subsequent liver damage, it is critical that patients adhere to the recommended dosing guidelines. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In cases of overdosage, it is imperative to recognize the potential for serious health consequences, particularly concerning liver damage. Healthcare professionals should be aware that exceeding the recommended dosage can lead to significant adverse effects.

Recommended Actions In the event of an overdose, immediate medical assistance is essential. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of hepatic impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare professionals should follow established guidelines for the management of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose and the clinical presentation 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 include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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 help 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 professional 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 seek guidance from 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 temperatures ranging from 15º to 30ºC (59º to 86ºF). 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 ensure the product's efficacy 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)