Daytime Cold and Flu

Description

This formulation is designed for daytime cold and flu relief, providing multi-symptom alleviation. Each dose contains 325 mg of acetaminophen, serving as a pain reliever and fever reducer; 10 mg of dextromethorphan HBr, acting as a cough suppressant; and 5 mg of phenylephrine HCl, functioning as a nasal decongestant. The product effectively relieves aches, fever, sore throat, cough, and nasal congestion. It is non-drowsy and suitable for individuals aged 6 years and older. The formulation is alcohol-free and antihistamine-free. The packaging includes a tamper-evident feature, and the product should not be used if the printed safety seal around the dosage cup or under the cap is broken or missing.

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

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a healthcare professional for children aged 4 to under 6 years, as specific dosing instructions should be obtained. The product is not recommended for use in children under 4 years of age.

Patients should not exceed 4 doses within a 24-hour period. It is essential to measure the dosage using only the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure proper measurement. When utilizing both Day Time and Night Time formulations, healthcare professionals should advise patients to carefully read each label to confirm the correct dosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is important not to exceed the recommended dosage of this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage for adults is 4 doses (30 mL each) within a 24-hour period. For children, the maximum is 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can lead to unintentional overdose. Additionally, adults consuming three or more alcoholic beverages daily while using this product are at an increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which necessitates immediate medical attention. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use and seek medical help without delay.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly.

Healthcare professionals should be vigilant regarding the potential for overdose, which can result in liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Quick medical intervention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further increased if acetaminophen 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 aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, medical advice should be sought. A worsening fever or one that lasts more than 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache are also indicators of a potential serious condition, warranting immediate medical evaluation.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of a liver warning: if a child takes more than 4 doses of 15 mL each within a 24-hour period, medical advice should be sought. Additionally, caregivers should be instructed to stop use and consult a doctor if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days, or if a fever worsens or lasts more than 3 days.

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 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. 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 healthcare 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 mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this maximum is 4 doses (30 mL each) within a 24-hour period, while for children, it is 4 doses (15 mL each) in the same timeframe. Additionally, patients should be advised against taking this product concurrently with other medications that contain acetaminophen, as this may increase the risk of liver damage.

Patients with a history of liver disease are strongly encouraged to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should exercise caution, as the risk of liver damage is heightened when using this product.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. This step is vital for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of prompt evaluation and treatment.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. Early intervention can significantly impact patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage may lead to serious health risks, including liver damage. In the event of an overdose, patients must be instructed to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be encouraged to consult with their healthcare provider prior to use if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, a sodium-restricted diet, 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 that produces excessive phlegm (mucus) should also seek medical advice before using the medication.

Furthermore, it is essential for patients to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking the blood-thinning medication warfarin, 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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

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)