Cold and Flu

Description

This product is a liquid formulation containing acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. It is intended for use by individuals aged 6 years and older. The product is presented in a 12 fluid ounce (355 mL) container with a menthol flavor. The National Drug Code (NDC) is 0363-9912-02. 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 distributed by Walgreen Co., located in Deerfield, IL 60015.

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

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 product 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:

• 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. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• 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 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 in conjunction 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.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken before use of this product. Patients should be advised to consult a healthcare provider if they have any of the following conditions: 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. Additionally, it is essential to consult a doctor or pharmacist prior to use if the patient is taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Further, if fever worsens or persists beyond three days, or if redness or swelling occurs, medical advice should be sought. New symptoms, or worsening pain, nasal congestion, or cough lasting more than five days in children or seven days in adults, warrant immediate consultation. A cough that recurs or is accompanied by a rash or headache that persists should also be evaluated, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg of acetaminophen within a 24-hour period, and children should not exceed 5 doses in the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of 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.

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

Common adverse reactions that may necessitate discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. In children, if pain, nasal congestion, or cough worsens or persists for more than five days, or in adults for more than seven days, medical consultation is advised. A cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition.

Patients with certain pre-existing conditions should consult a healthcare provider before using this product. These conditions include difficulty in urination due to prostate enlargement, cough with excessive phlegm, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), heart disease, diabetes, thyroid disease, liver disease, and high blood pressure. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from 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, 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 within two weeks of discontinuing 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 warranted to ensure safe use and to avoid potential interactions that could affect bleeding risk.

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

There is no specific information available 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 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 should consult a healthcare professional prior to use if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before using this medication, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function 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. Adults who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage.

It is imperative that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. Reports of these adverse reactions have been received voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage and not exceeding it. Patients should be made aware that taking more than the prescribed amount can lead to serious health risks.

In the event of an overdose, healthcare providers must instruct patients to seek medical help immediately or contact a Poison Control Center. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of overdose.

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

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.

View product document (PDF)