Daytime Cold and Flu Relief

Description

This product is a non-drowsy, multi-symptom formulation designed for daytime cold and flu relief. It contains the following active ingredients: acetaminophen, which serves as an analgesic and antipyretic; dextromethorphan, a cough suppressant; and phenylephrine, a nasal decongestant. The formulation effectively alleviates symptoms such as aches, fever, sore throat, nasal congestion, and cough.

The dosage form is presented as softgels, specifically liquid-filled capsules. This product is free from alcohol and antihistamines. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, and Vicks®, DayQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

The packaging includes a tamper-evident feature; do not use if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering. For complete warnings and product information, retain the outer carton. This product is distributed by Supervalu Inc., Eden Prairie, MN 55344, USA.

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 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 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:

• Concurrent use 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.

• 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 uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as well as in patients who consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

Healthcare providers must emphasize the importance of adhering to the recommended dosage, as exceeding this can lead to liver damage. In instances of overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center or seek medical help without delay, regardless of whether signs or symptoms are present, as rapid intervention is essential for both adults and children.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; nervousness, dizziness, or sleeplessness develops; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms arise; 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 taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the 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.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and contact 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 with a rash or headache that persists. These symptoms could indicate a serious condition.

Prior to use, patients should consult a healthcare professional if they have 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 advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

An overdose warning is critical; taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is essential to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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 and potential hepatotoxicity.

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 or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, 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 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.

Healthcare professionals should be aware of the critical need for quick medical attention in cases of overdose, as this is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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. This precaution is essential to ensure safe and effective use of the medication in individuals with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

Patients should not exceed 4,000 mg of acetaminophen in a 24-hour period. Additionally, they should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of three or more alcoholic drinks daily while using this product is also contraindicated due to the potential for exacerbating liver injury.

Before using this product, patients with known liver disease are advised to consult a healthcare professional. It is essential to monitor liver function closely in these individuals, particularly if they are taking the medication for an extended period or at higher doses.

In the event of an overdose, which can lead to significant liver damage, immediate medical attention is necessary. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare professionals should be aware that early recognition and management of overdose symptoms can be vital in preventing severe complications. It is recommended that patients or caregivers be educated on the importance of adhering to prescribed dosages and the potential risks associated with exceeding these limits.

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 assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should be advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness.

If a patient’s fever worsens or lasts more than three days, or if they notice any redness or swelling, they should be instructed to stop use and contact a healthcare provider. Patients should also be made aware that new symptoms or a cough that returns or occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before 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, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm.

Lastly, patients should be advised to seek guidance from a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin.

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 efficacy. Care should be taken to avoid exposure to excessive heat, as this 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)