Topcare Daytime Cold and Flu Relief

Description

TopCare® health DayTime Cold & Flu Relief is formulated to provide multi-symptom relief, comparable to the active ingredients found in Vicks® DayQuil®. This liquid formulation contains acetaminophen as a pain reliever and fever reducer, and dextromethorphan HBr as a cough suppressant. It is designed to alleviate symptoms such as headache, fever, sore throat, minor aches and pains, and cough. The product is alcohol-free and antihistamine-free, ensuring a non-drowsy experience. Each bottle contains 12 FL OZ (355 mL) of elderberry-flavored solution.

Uses and Indications

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

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. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is 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, it is advised to consult a physician for appropriate dosing. The medication is not recommended for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines and provide education on the importance of not exceeding the maximum dosage to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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 used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

General precautions should be observed prior to use. Individuals with liver disease, those experiencing a cough associated with excessive phlegm, or those with persistent or chronic coughs (such as those related to smoking, asthma, or emphysema) should consult a physician before use. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to using this product.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The national Poison Control Center can be reached at 1-800-222-1222.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or persists beyond 5 days in children or 7 days in adults; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These may indicate a serious underlying condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in the same timeframe, or if the medication is used concurrently with other products containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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 warning is also in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, those experiencing a cough with excessive phlegm, or individuals with a persistent or chronic cough (such as those associated with smoking, asthma, or emphysema) should seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are currently taking warfarin, a blood-thinning medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Additionally, the use of this product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to seek guidance from a healthcare provider before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 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 administration. The use of this medication is not recommended for children under 4 years of age.

In the event of an overdose, it is crucial to seek immediate medical attention for pediatric patients, even if no signs or symptoms are apparent.

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. 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. 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 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 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 consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin reddening, blisters, and rash. These events have been documented in the context of postmarketing surveillance and are presented without speculation regarding causality.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary 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 about the presence of acetaminophen in their medications, they should be encouraged to consult with 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 an MAOI within the past two weeks. Patients should be advised to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use.

Healthcare providers should counsel patients to discontinue use and consult a doctor if pain or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, patients should be advised to seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. They should also be informed to stop use and consult a doctor if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult their healthcare provider before using this product. Furthermore, those experiencing a cough with excessive phlegm (mucus) or a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before 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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare Daytime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)