Cold and Flu

Description

This product is a liquid formulation designed for daytime relief of cold and flu symptoms, including headache, fever, sore throat, minor aches and pains, nasal congestion, and cough. It contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The product is intended for use by individuals aged 6 years and older and is packaged in a 12 FL OZ (355 mL) container. The National Drug Code (NDC) for this product is 71141-179-32. It is manufactured by LIDL® F-012-02 ORG. The packaging includes a tamper-evident feature, and it should not be used if the printed neck wrap is broken or missing. This product is not manufactured or distributed by The Procter & Gamble Company, which owns the registered trademark Vicks® DayQuil® Cold & Flu.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, nasal congestion, headache, minor aches and pains, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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 to exceed 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 adhering to the maximum limit of 4 doses in a 24-hour timeframe.

It is imperative that the provided dose cup is utilized for accurate measurement. The medication should not be administered to children under 6 years of age. Healthcare professionals should ensure that patients are informed not to exceed the recommended 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, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken concurrently with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

General precautions should be observed prior to use. Individuals should consult a physician if they have difficulty urinating due to prostate enlargement, a cough associated with excessive phlegm, a persistent or chronic cough (such as that seen in smoking, asthma, or emphysema), heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the user is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Users should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults. A return of cough accompanied by rash or headache that persists should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in 24 hours, the product is used concurrently with other medications containing acetaminophen, or an adult 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, 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 2 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 nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than 3 days; if redness or swelling is present; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults. Additionally, if a cough recurs or occurs with a rash or headache that persists, these may indicate a serious condition requiring medical evaluation.

It is recommended that patients seek medical advice prior to using this product if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before use.

Drug Interactions

Concurrent use 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 prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid potential hypertensive crises.

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 warranted to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In contrast, adults and children aged 12 years and over may take 30 mL every 4 hours.

Healthcare professionals should be aware that administering more than 5 doses within a 24-hour period may lead to severe liver damage in pediatric patients. Caution is advised when prescribing this medication to ensure adherence to the recommended dosing guidelines.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics 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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The risk of liver injury increases significantly if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of hepatotoxicity.

It is also important for patients with compromised liver function to be aware that the consumption of 3 or more alcoholic drinks daily while using this product may exacerbate the potential for liver damage.

Patients with a history of liver disease should consult a healthcare professional prior to using this product to ensure safe usage and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate care based on clinical judgment and established protocols.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. 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 recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to inform patients to discontinue use and consult a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening fever that lasts more than three days; any redness or swelling; the emergence of new symptoms; or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. Additionally, patients should be made aware that a returning cough or one that occurs alongside a rash or headache that lasts could indicate a serious condition, warranting further medical evaluation.

Healthcare providers should also encourage patients to consult a doctor before using the medication if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland; a cough accompanied by excessive phlegm; a persistent or chronic cough associated with smoking, asthma, or emphysema; heart disease; diabetes; thyroid disease; liver disease; or high blood pressure. Furthermore, 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 upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication. Additionally, resources are available for understanding the risks of medicine abuse among teens, specifically at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

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