Day Time Multi-Symptom Cold and Flu Relief

Description

This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark Vicks® DayQuil™ LiquiCaps™. It is designed with a tamper-evident feature; therefore, it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the warning provided. The maximum allowable dosage is 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

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

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.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This is due to potential interactions that may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

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 maximum daily dosage of 8 Liquid Caps is exceeded within a 24-hour period. This limit is the highest recommended for this product. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

Emergency Medical Help In cases of accidental overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Timely medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and Consultation Patients should be advised to stop taking the product and consult a healthcare professional if they experience any of the following: nervousness, dizziness, sleeplessness, worsening symptoms lasting more than five days (for children) or seven days (for adults), fever that worsens or persists beyond three days, presence of redness or swelling, emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 Liquid Caps within a 24-hour period, particularly when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily.

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 of severe sore throat that 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 they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Signs of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this medication with any other drug 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 for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI, as this may lead to 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 necessary to ensure safe use and to avoid potential interactions that could increase the risk of bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Day Time Multi-Symptom Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adults and children 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.

Healthcare professionals should advise caregivers to discontinue use and seek medical advice if symptoms worsen or persist for more than 5 days in children.

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 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum recommended dosage of 8 Liquid Caps in a 24-hour period. This maximum daily amount should not be exceeded under any circumstances.

Additionally, patients with compromised liver function should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Furthermore, consumption of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for severe liver injury.

Healthcare providers should assess liver function and consider these factors when prescribing this product to patients with hepatic impairment to ensure safe and effective use. Regular monitoring of liver function tests may be warranted in these patients to detect any signs of hepatic toxicity early.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual consumes more than 8 Liquid Caps within a 24-hour period, which is the maximum recommended daily dosage for this product. This risk is further heightened when the product is taken in conjunction with other medications containing acetaminophen or when the individual consumes three or more alcoholic beverages daily while using this product.

Healthcare professionals should be vigilant for symptoms indicative of liver damage, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Immediate medical attention is warranted if an overdosage is suspected.

Management of overdosage should involve prompt assessment and supportive care. Activated charcoal may be administered if the patient presents within a suitable timeframe post-ingestion, and N-acetylcysteine should be considered as an antidote for acetaminophen toxicity. Continuous monitoring of liver function tests is essential to evaluate the extent of liver injury and guide further treatment decisions.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

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 the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment.

In the event of an accidental overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent. This proactive approach can significantly mitigate potential health risks associated with overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Day Time Multi-Symptom Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)