Topcare Nite Time Day Time

Description

Top Care health offers a range of cold and flu relief products designed for multi-symptom management. The daytime formulation contains acetaminophen as a pain reliever and fever reducer, dextromethorphan HBr as a cough suppressant, and phenylephrine HCl as a nasal decongestant. This formulation is alcohol-free, antihistamine-free, and non-drowsy, providing relief from symptoms such as headache, fever, sore throat, minor aches and pains, nasal congestion, and cough. It is available in a package of 32 softgels.

The nighttime formulation also features acetaminophen for pain and fever relief, along with dextromethorphan HBr for cough suppression and doxylamine succinate as an antihistamine. This product is designed to alleviate symptoms including headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. It is alcohol-free and comes in a package of 16 softgels.

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, minor aches and pains, sore throat, headache, runny nose, sneezing, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. 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 two softgels taken with water every six hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated 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 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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should verify with a healthcare professional if their current medications include an MAOI.

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

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), difficulty urinating due to an enlarged prostate, diabetes, heart disease, high blood pressure, or thyroid disease.

Emergency Medical Help In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Discontinuation of Use Patients should be advised to stop taking the product and consult a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; cough recurs or is accompanied by a rash or headache lasting longer than expected; or if they experience nervousness, dizziness, or insomnia. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

Patients should consult a doctor promptly if they experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a potential effect. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, since alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

For those using the Daytime Cold & Flu formulation, patients should seek medical advice if they experience nervousness, dizziness, or sleeplessness, or if pain, nasal congestion, or cough worsens or lasts more than seven days. Similar to the Nighttime Cold & Flu, worsening fever, redness or swelling, new symptoms, or a recurring cough with rash or headache should prompt a consultation with a healthcare provider.

Patients with liver disease, glaucoma, excessive phlegm, breathing problems such as emphysema or chronic bronchitis, persistent cough due to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland should consult a doctor before use. Additionally, those with diabetes, heart disease, high blood pressure, or thyroid disease should seek medical advice prior to using the Daytime Cold & Flu formulation. Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a doctor or pharmacist before use.

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

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of this product alongside warfarin, an anticoagulant, may elevate the risk of bleeding. Patients should be monitored closely for signs of increased bleeding and dosage adjustments may be necessary based on clinical judgment.

Monoamine Oxidase Inhibitors (MAOIs) Patients currently taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease should avoid using this product. It is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI to prevent potential adverse effects.

CNS Depressants The co-administration of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, and monitoring for increased sedation may be warranted.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Nite Time Day Time (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this product; however, caution is advised due to potential increased sensitivity to side effects. Notably, geriatric patients may experience heightened drowsiness from doxylamine succinate, which necessitates careful monitoring of their response to the medication.

The product contains acetaminophen, which carries a risk of severe liver damage if the maximum daily dosage of 4,000 mg is exceeded within a 24-hour period. Elderly patients who consume three or more alcoholic drinks daily should exercise particular caution when using this product, as the combination may exacerbate the risk of liver injury.

Furthermore, it is recommended that elderly patients consult a healthcare provider prior to use if they have pre-existing conditions such as liver disease, diabetes, heart disease, high blood pressure, thyroid disease, or urinary difficulties related to an enlarged prostate gland. This consultation is essential to ensure safe and effective use of the product 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 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 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. Additionally, patients with liver disease are advised to seek medical guidance before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to the presence of acetaminophen. Severe liver damage may occur if the total daily dosage of acetaminophen exceeds 4,000 mg, if it is taken concurrently with other products containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be necessary in these patients to ensure safety and efficacy.

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, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to initiate appropriate treatment protocols based on the specific circumstances of the overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included skin reddening, blisters, and rash. Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness has also been observed in some cases. It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects, leading to increased drowsiness.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in its original container to maintain stability and integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 6 hours for Nitetime Cold & Flu and every 4 hours for Daytime Cold & Flu. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Topcare Nite Time Day Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)