Topcare Nite Time Cold and Flu

Description

TopCare® health Nite Time Cold & Flu is a maximum strength formulation designed to alleviate symptoms associated with severe cold and flu. This product is comparable to Vicks® NyQuil® and features the proprietary VAPOR ICE® technology for enhanced relief. Each dosage form contains active ingredients including acetaminophen as a pain reliever and fever reducer, dextromethorphan HBr as a cough suppressant, doxylamine succinate as an antihistamine, and phenylephrine HCl as a nasal decongestant. The formulation addresses minor aches and pains, fever, nasal congestion, sinus pressure, sneezing, runny nose, and cough. The product is supplied in a package containing 24 caplets, with actual size indicated for reference.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing. Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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 dosage should not exceed 8 caplets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 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:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for 2 weeks following the discontinuation of such treatment. This is to prevent potential serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, seek advice from a healthcare professional.

• In individuals with a history of allergic reactions to this product or any of its ingredients, to avoid the risk of severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients should be instructed 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, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients experiencing a persistent cough with excessive phlegm or those with urinary difficulties due to an enlarged prostate gland should seek medical advice before using this product.

Patients should also consult a healthcare provider or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin, as these medications may interact with acetaminophen.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, combines it with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer 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 with a rash or headache that persists. These symptoms could indicate a serious underlying condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues should seek medical advice before using this product. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare professional prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients, particularly children, may experience excitability, and marked drowsiness may occur. Alcoholic beverages should be avoided, as they can enhance drowsiness, especially when combined with sedatives or tranquilizers. Caution is advised when driving or operating machinery.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when considering the use of this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. It is recommended to seek guidance from a healthcare provider if an MAOI is currently being taken or has been discontinued within the past two weeks.

The concomitant administration of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Close monitoring of coagulation parameters is advised in patients receiving both therapies.

Additionally, the use of alcohol, sedatives, and tranquilizers alongside this medication may potentiate drowsiness. Patients should be advised to exercise caution and consider avoiding these substances to mitigate the risk of excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Nite Time Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). 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 contraindicated in children under 4 years of age. For dosing, adults and children aged 12 years and older may take 2 caplets with water every 4 hours.

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

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 patient's specific condition.

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, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on therapy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

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 procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any emerging complications. It is vital to maintain open communication with poison control and follow their guidance throughout the management process.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Severe skin reactions, including skin reddening, blisters, and rash, have been associated with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. Other reported symptoms include nervousness, dizziness, and insomnia.

Patients have also reported worsening pain, nasal congestion, or cough lasting more than seven days, as well as fever persisting beyond three days. The presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that persists may indicate a serious condition requiring medical evaluation.

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, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed 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 consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged 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 advised against its use. Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should also be informed to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. New symptoms that arise should prompt a consultation with a healthcare provider, as should a cough that returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be cautioned against exceeding the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Healthcare providers should recommend that patients 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, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent or chronic cough related to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be advised to speak with a doctor or pharmacist if they are taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes NDC numbers, ensuring proper identification and traceability. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To maintain product integrity, it is essential to protect the product from light. Additionally, the product must be kept out of reach of children to ensure safety. Once opened, the product should be discarded to prevent any potential contamination or degradation.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 caplets taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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