Daytime Cold and Flu

Description

This formulation contains Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, and Phenylephrine HCl 5 mg. It is designed for individuals aged 6 years and older. The product is non-drowsy and alcohol-free, and it does not contain antihistamines. The packaging includes a tamper-evident feature; usage is not recommended 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 physician 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 administration.

When utilizing both Day Time and Night Time formulations, healthcare professionals should advise patients to carefully read each label to confirm the correct dosing instructions.

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 medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning Adults should not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, as this represents the maximum daily amount. For children, the maximum is 4 doses (15 mL each) in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, healthcare professionals should advise patients to consult a physician promptly.

Stop Use and Consult a Doctor Patients should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever worsens or persists for more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that lasts should also prompt a consultation, as these may indicate a serious condition.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

No specific laboratory tests are recommended for monitoring in relation to the use of this product.

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 the 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.

A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop 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, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache lasting should also prompt a consultation, as these may indicate a serious condition.

Before using acetaminophen, patients should consult a healthcare professional if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, a sodium-restricted diet, or difficulty urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or a cough that produces excessive phlegm should also seek medical advice prior to use. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using acetaminophen.

An overdose of acetaminophen, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are 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 should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin to ensure safe and effective use. Monitoring of coagulation parameters may be warranted in such cases.

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 years and older may be administered the medication at a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The medication is not recommended for children under 4 years of age.

Healthcare providers should be aware that exceeding 4 doses (15 mL each) within a 24-hour period may result in severe liver damage. Caution is advised when prescribing to pediatric patients, particularly regarding adherence to recommended dosing guidelines.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in elderly patients.

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 on 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this is defined as more than 4 doses (30 mL each) within a 24-hour period, while for children, it is more than 4 doses (15 mL each) in the same timeframe. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. It is crucial to adhere strictly to the recommended dosage to avoid the risk of overdose, which may lead to 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 without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, which may occur when the recommended dosage is exceeded. 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. Prompt action is vital, regardless of whether any symptoms are present, as both adults and children are at risk.

Potential Symptoms While specific symptoms of overdose may not always be immediately apparent, vigilance is necessary. Healthcare professionals should monitor for any signs of liver impairment or other adverse effects, even in the absence of overt symptoms.

Management Procedures Upon identification of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. The importance of rapid response cannot be overstated, as timely intervention can significantly influence patient outcomes.

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 compound in these areas.

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 to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult a doctor before using the medication 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 should be advised to seek medical advice if they have a cough that produces excessive phlegm (mucus).

Healthcare providers should also recommend that patients consult a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to seek medical attention if pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. Furthermore, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs alongside a rash or headache that lasts, patients should be encouraged to contact their healthcare provider.

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 the product's 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)