Daytime Cold and Flu

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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

The medication should be taken only as directed, and healthcare professionals are advised to refer to the Overdose warning for further guidance. Dosing must be measured using the dose cup provided with the product, and it is essential to keep the dose cup with the product to ensure accurate measurement.

For adults and children aged 12 years and over, 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 recommended dosage is 15 mL every 4 hours, also adhering to the maximum limit of 4 doses in a 24-hour period. The use of this medication is not recommended for children under 6 years of age.

Contraindications

Use of this product is contraindicated in patients who consume alcoholic beverages due to the potential for adverse interactions. Additionally, it is essential to adhere strictly to the recommended dosage; exceeding the directed amount may lead to overdose and associated risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults and children over 12 years of age must not exceed 4 doses (30 mL each) within a 24-hour period, as this is the maximum daily amount. For children aged 6 to 12 years, the maximum daily amount is 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen. Additionally, patients who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General precautions include the avoidance of concurrent use with any other products 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. Furthermore, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medications, which are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from its use.

Emergency medical help should be sought immediately if a skin reaction occurs.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults warrants medical attention. A fever that worsens or persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and severe allergic reactions.

Severe liver damage may occur if adults and children over 12 years of age exceed 4 doses (30 mL each) in a 24-hour period, which is the maximum daily amount for this product. Similarly, children aged 6 to 12 years should not take more than 4 doses (15 mL each) in 24 hours. The risk of liver damage is also heightened if the product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of such a reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat lasting more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Overdose of this product can lead to serious health complications, including liver damage. In the event of an accidental overdose, it is crucial to seek professional assistance or contact a Poison Control Center immediately, as timely medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough accompanied by excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this product is also contraindicated in patients currently taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such therapy. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional prior to using this product.

Additionally, caution is advised when using this product in conjunction with warfarin, a blood-thinning medication. Patients should seek guidance from a healthcare provider or pharmacist before initiating use to ensure safe co-administration and appropriate monitoring of anticoagulation levels.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL every 4 hours. However, it is important to note that children in this age group should not exceed 4 doses (15 mL each) within a 24-hour period, as this represents the maximum daily amount for this product.

The use of this product is contraindicated in children under 6 years of age. In the event of an overdose, prompt medical attention is essential for pediatric patients, 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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur under certain conditions, particularly in individuals with compromised liver function.

For adults and children over 12 years of age, the maximum recommended dosage is 4 doses (30 mL each) within a 24-hour period. For children aged 6 to 12 years, the maximum dosage is 4 doses (15 mL each) in the same timeframe. It is critical that patients do not exceed these limits, as doing so may significantly increase the risk of liver damage.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further elevate the risk of hepatotoxicity. Furthermore, adults who consume 3 or more alcoholic drinks daily while using this product should exercise caution, as alcohol can exacerbate the potential for liver injury.

Regular monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and to mitigate the risk of severe adverse effects.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdosing.

In cases of accidental overdose, immediate action is essential. Healthcare providers should advise patients or caregivers to seek professional assistance without delay. Contacting a Poison Control Center at 1-800-222-1222 is strongly recommended to obtain expert guidance on managing the situation.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risks associated with overdose and improve patient outcomes.

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

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. Patients should also be informed to contact a healthcare professional if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough returns or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be cautioned not to exceed the recommended dosage and to avoid consuming alcoholic drinks, as this may increase the risk of adverse effects.

Healthcare providers should encourage patients to consult a doctor before using the product if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a cough accompanied by excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product to avoid potential interactions.

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 room temperature, maintaining a range of 15-30°C (59-86°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling should be observed to ensure optimal quality and efficacy.

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)