Daytime Cold and Flu

Description

Acetaminophen, 325 mg, is a pain reliever and fever reducer. Dextromethorphan HBr, 10 mg, serves as a cough suppressant, while phenylephrine HCl, 5 mg, acts as a nasal decongestant. This formulation is designed to provide relief without causing drowsiness and is free from alcohol and antihistamines. The dosage form is presented as softgels, specifically liquid-filled capsules.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 softgels with water every 4 hours, not to exceed 4 doses within a 24-hour period. It is essential that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

For children under 12 years of age, the use of this product is not recommended.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure proper dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients experiencing a cough with excessive phlegm should seek medical advice. It is also crucial to inquire about the concurrent use of warfarin, a blood-thinning medication, as it may interact with acetaminophen.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Discontinuation of Use Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical; patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

In addition, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a healthcare provider immediately.

Patients are advised to stop using the product and seek medical advice if they notice any of the following: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; redness or swelling; new symptoms; or a cough that returns or occurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Overall, careful monitoring for these adverse reactions is essential to ensure patient safety while using this product.

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 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 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 mitigate the risk of increased bleeding.

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 under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses in a 24-hour period.

In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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. 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 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 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 be closely monitored due to the potential for severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit can lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. In the event of an overdose, which can occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

Taking more than the recommended dose of this medication can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can be vital in mitigating potential harm and ensuring appropriate management of the situation.

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 the following adverse reactions: severe skin reactions, which may include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days. Additionally, they should stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. If fever worsens or lasts longer than 3 days, or if any redness or swelling occurs, patients should also consult a healthcare professional. New symptoms that arise during treatment should prompt a discussion with a doctor, as should a cough that returns or occurs alongside a rash or persistent headache.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) should consult a healthcare professional. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist before proceeding.

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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

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)