Cold and Flu

Description

Acetaminophen, dextromethorphan HBr, and phenylephrine HCl are the active ingredients in this formulation. The product is presented in a liquid dosage form, with a total volume of 12 fluid ounces (355 mL). It is important to note that the product features a tamper-evident design; 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 is the owner of 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, minor aches and pains, cough due to minor throat and bronchial irritation, and headache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours, also limited to a maximum of 4 doses in a 24-hour timeframe.

It is imperative to instruct patients to utilize only the dose cup provided with the medication to ensure accurate dosing. The use of this medication is not recommended for children under 6 years of age.

Patients should be cautioned against exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI status with a healthcare provider is recommended if there is any doubt.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. The risk is heightened if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

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

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond 3 days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 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

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. This risk is heightened if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should also be alert for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any 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.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness; worsening fever lasting more than three days; presence of redness or swelling; emergence of new symptoms; and worsening pain, nasal congestion, or cough lasting more than five days in children or seven days in adults. Additionally, if a cough recurs or occurs with a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

Patients should seek medical advice before using this product if they have difficulty urinating due to prostate enlargement, a cough accompanied by 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, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with other products 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 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 serious interactions.

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 safety and efficacy.

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 older may take 30 mL every 4 hours.

Healthcare professionals should be aware of a liver warning indicating that if a child takes more than 5 doses within a 24-hour period, there may be a risk of liver damage. Additionally, if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days, further evaluation is warranted.

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 adverse effects or changes in therapeutic response, 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 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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The following considerations are essential for this patient population:

Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period. For children, the risk increases if they take more than 5 doses in a 24-hour timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of liver injury. Patients who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk for liver damage.

It is imperative that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these individuals to ensure safety and prevent potential adverse effects.

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 as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay. Additionally, prompt medical attention is critical for both adults and children in cases of overdose, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, 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 about the presence of acetaminophen in their medications, 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 with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should be advised to stop using the product and seek medical advice if their fever worsens or persists for more than three days, if they notice any redness or swelling, or if new symptoms arise. Additionally, patients should be instructed to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. They should also be made aware that a returning cough or one accompanied by a rash or persistent headache may indicate a serious condition, warranting 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 difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they have any of the following conditions: heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should be aware of the potential for medicine abuse, particularly among adolescents, and can refer to www.StopMedicineAbuse.org for further information. The medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older, and 15 mL every 4 hours for children aged 6 to under 12 years. It is contraindicated for children under 6 years. Additionally, patients who are pregnant or breastfeeding should consult a healthcare professional prior to use.

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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