Day Time Cold and Flu

Description

No Description information provided.

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, fever, nasal congestion, sinus pressure, 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 using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm correct dosing.

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, this 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

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult exceeds 4 doses (30 mL each) within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. Additionally, the risk is heightened when acetaminophen is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant in assessing patients for severe sore throat symptoms. 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 physician is warranted.

General precautions should be taken when considering this product for patients with specific health conditions. Patients should be advised to consult a healthcare provider prior to use if they have 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 with excessive phlegm should seek medical advice. It is also recommended that patients on the anticoagulant warfarin consult with a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond 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 or is accompanied by a rash or headache lasting beyond a reasonable duration may indicate a serious condition requiring 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 heightened 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, patients are advised 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 consult a healthcare professional promptly.

Patients are advised to stop use and seek medical advice 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 consultation is recommended. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that persists should also prompt patients to seek medical attention, as these may indicate a serious condition.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Day Time 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 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 the liver warning associated with the use of this medication; if a child takes more than 4 doses (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 the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

In cases of suspected overdose, immediate medical attention is critical for pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, 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.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the following maximum daily doses: adults should not take more than 4 doses (30 mL each) of acetaminophen in a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to serious health consequences, including potential liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be vigilant in assessing the situation and providing appropriate care to mitigate the risks associated with overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help 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 signs or symptoms are apparent.

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 drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to caution patients against using this product 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 should be instructed to discontinue use 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. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before 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, particularly if the cough is accompanied by excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to using this product.

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 Day Time Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)