Daytime Cold and Flu

Description

This product contains a formulation designed to provide multi-symptom relief from cold and flu symptoms, including aches, fever, sore throat, cough, and nasal congestion. It is non-drowsy and suitable for daytime use. The active ingredients include acetaminophen (325 mg), which serves as a pain reliever and fever reducer; dextromethorphan HBr (10 mg), a cough suppressant; and phenylephrine HCl (5 mg), a nasal decongestant. The product is intended for individuals aged 6 years and older and is both alcohol-free and antihistamine-free. The liquid dosage form is presented in fluid ounces (FL OZ) and milliliters (mL).

The product is tamper evident; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. This formulation is not manufactured or distributed by The Procter & Gamble Company, and Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. It is distributed by Lidl US, LLC, located at 3500 S. Clark Street, Arlington, VA 22202. For more information, visit www.lidl.com.

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, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours, not exceeding 4 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour period. For children aged 4 to under 6 years, it is essential to consult a physician before administration. The product is not recommended for children under 4 years of age.

Healthcare professionals should instruct patients to measure the dosage using only the dosing cup provided with the product, as other dosing devices may lead to inaccurate dosing. It is important to keep the dosing cup with the product to ensure proper measurement.

When utilizing both Day Time and Night Time formulations, practitioners should emphasize the importance of carefully reading each label to confirm the correct dosing instructions. Adherence to these guidelines is crucial to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is important not to exceed the recommended dosage of this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, as this represents the maximum daily amount. For children, the limit is 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can lead to unintentional overdose. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

Healthcare professionals must emphasize the importance of recognizing the signs of overdose, which can lead to liver damage. 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, even if no symptoms are apparent.

Patients should be advised to stop using the product and consult a healthcare provider if any of the following occur: redness or swelling, the emergence of new symptoms, feelings of nervousness, dizziness, or sleeplessness, worsening fever lasting more than 3 days, or if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, medical evaluation is warranted, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further increased if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

A sore throat warning is also in place; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are instructed to stop use and consult a doctor if they experience redness or swelling, new symptoms, nervousness, dizziness, sleeplessness, or if fever worsens or lasts more than 3 days. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if a cough recurs with a rash or headache, these may indicate a serious condition requiring medical evaluation.

Before using this product, patients should seek medical advice if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, a sodium-restricted diet, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

An overdose warning is also included; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is critical 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 if no signs or symptoms are immediately apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Patients currently taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters and potential dosage adjustments of warfarin.

Additionally, this medication is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. The interaction may lead to serious side effects, including hypertensive crises.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older may receive a dosage of 30 mL every 4 hours, similar to adults and children aged 12 years and older. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is advised to consult a healthcare professional for children aged 4 to under 6 years, as specific dosing guidelines are not provided. The medication is contraindicated in children under 4 years of age.

Healthcare professionals should be aware that administering more than 4 doses (15 mL each) within a 24-hour period may result in severe liver damage. It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is essential for pediatric patients, even if no signs or symptoms are present.

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 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 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

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. 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. Severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this is defined as more than 4 doses (30 mL each) within a 24-hour period, and for children, it is more than 4 doses (15 mL each) in the same timeframe. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

It is imperative that patients with known liver disease consult a healthcare professional prior to use. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and to act promptly.

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 without delay. Quick intervention is essential, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of vigilance even in the absence of noticeable signs or symptoms.

Prompt medical attention can be critical in managing the potential consequences of an overdose, and healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary actions to take in such situations.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) 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 if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should consult with a doctor or pharmacist prior to use.

It is important to counsel patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to verify the presence of acetaminophen in their medications by consulting a healthcare professional if they are unsure.

Patients should be instructed to discontinue use and consult a doctor if they experience redness or swelling, new symptoms, nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if a fever worsens or persists beyond three days, or if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. Patients should also be advised to stop use and contact a doctor if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must not 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, heart disease, thyroid disease, diabetes, high blood pressure, or if they are on a sodium-restricted diet. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients experiencing a cough with excessive phlegm or those having difficulty urinating due to an enlarged prostate gland should consult a healthcare professional prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before using this product.

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 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain 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)