Daytime Cold and Flu Relief

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. The provided dose cup must be utilized for accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare professional is advised before administration. The product is not recommended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty 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 poses a risk of severe liver damage under certain conditions. Healthcare professionals should be aware that the following situations may lead to significant hepatic injury:

• Adults should not exceed 4 doses (30 mL) within a 24-hour period, which is the maximum daily amount for this product.

• Children should not exceed 4 doses (15 mL) within a 24-hour period, also the maximum daily amount for this product.

• Concurrent use with other medications containing acetaminophen increases the risk of liver damage.

• Adults consuming 3 or more alcoholic drinks daily while using this product are at heightened risk for liver injury.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative 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, prompt consultation with a healthcare provider is advised.

General precautions should be taken prior to use. Patients should be advised to consult a physician if they have any of the following conditions:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Difficulty urinating due to an enlarged prostate gland

• Cough associated with excessive phlegm (mucus)

• Persistent or chronic cough, such as that associated with smoking, asthma, or emphysema

• A sodium-restricted diet

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their 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 for more than 3 days

• Presence of redness or swelling

• Emergence of new symptoms

• Recurrence of cough or occurrence of cough with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Adults should not take more than 4 doses (30 mL) within a 24-hour period, while children should not exceed 4 doses (15 mL) in the same timeframe. The risk of liver damage is heightened if the product 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 may also experience severe skin reactions due to acetaminophen, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative that patients discontinue use and seek immediate medical attention.

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

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare professional include 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 persists or worsens beyond 3 days, medical advice should be sought. Patients should also be alert for signs of redness or swelling, new symptoms, or a cough that returns or occurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate should consult a healthcare provider. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, as well as individuals on a sodium-restricted diet, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding complications. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief (acetaminohpen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may be administered 30 mL every 4 hours, while those aged 6 to under 12 years should receive 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.

The maximum allowable dosage for pediatric patients is 4 doses (15 mL) within a 24-hour period. Caution is warranted, as severe liver damage may occur if a child exceeds this maximum dosage. Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if a child's pain, nasal congestion, or cough worsens or persists beyond 5 days.

Geriatric Use

There is no specific information available 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 the safety of both the mother and the developing fetus.

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, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum daily dosage for adults is 4 doses (30 mL) within a 24-hour period, and for children, it is 4 doses (15 mL) in the same timeframe. Exceeding these limits may lead to significant hepatic injury.

Additionally, patients should be aware that the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease 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 prevent potential adverse effects.

Overdosage

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 aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 potential effects in nonclinical settings.

Postmarketing Experience

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

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 informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the past two weeks. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. They should also be informed 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 be particularly vigilant and seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, a persistent or chronic cough (such as that related to smoking, asthma, or emphysema), or if they are on a sodium-restricted diet. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

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 room temperature, ensuring that it is not subjected to refrigeration. Proper storage conditions are crucial to maintain 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)