Daytime Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours as needed.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations.

The use of this medication is not recommended for children under the age of 4.

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

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period (the maximum daily amount), concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages 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. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. It is crucial that patients do not exceed the recommended dosage while using this product.

In cases of accidental overdose, immediate professional assistance should be sought, or the Poison Control Center should be contacted. Timely medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than 5 days in children or 7 days in adults; fever worsens or persists for more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum recommended dosage of 4 doses in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

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

Participants should be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks following the cessation of such medication. Individuals with a known allergy to this product or any of its ingredients should also refrain from use.

Patients are encouraged to seek medical advice prior to using this product if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Patients should discontinue use and consult a healthcare provider if pain or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or persists beyond 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

In the event of an accidental overdose, it is crucial for patients to seek professional medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a doctor prior to use.

For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if pain or cough worsens or persists beyond 5 days in children or 7 days in adults.

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 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 patients 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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an accidental overdose, it is imperative to seek professional assistance or contact a Poison Control Center without delay. Overdosage can pose significant health risks, and prompt medical attention is essential for both adults and children, regardless of whether any signs or symptoms are immediately apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is crucial to monitor the patient closely and provide appropriate medical intervention as needed. Early recognition and management of an overdose can significantly improve outcomes and reduce the risk of severe adverse effects.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider or pharmacist 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 instruct patients to discontinue use and seek medical advice if pain or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, patients should be advised to stop use and consult a doctor if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop.

Patients should also be informed to seek medical attention if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition. It is important to emphasize that patients should not exceed the recommended dose while using this product.

Before using this product, patients with liver disease should be encouraged to consult their healthcare provider. Furthermore, patients experiencing a cough accompanied by excessive phlegm (mucus), or those with a persistent or chronic cough due to smoking, asthma, or emphysema, should also seek medical advice prior to use.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to inspect the carton and blister units prior to use; do not use the product if the carton is open or if the blister unit is broken.

For optimal storage, the product should be maintained at a temperature range of 15° to 30°C (59° to 86°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

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)