Topcare Nite Time Cold and Flu

Description

No description information is available for the specified drug.

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 adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication. 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 before administration. The medication is contraindicated for children under 4 years of age; therefore, it should not be used in this age group.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent 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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• Use in children for the purpose of inducing sleep is contraindicated.

• History of allergic reactions to this product or any of its ingredients precludes its use.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under specific circumstances. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period, while children should not take more than 5 doses in the same timeframe. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, glaucoma, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or any breathing problems such as emphysema or chronic bronchitis. Additionally, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, should also consult a healthcare provider.

Patients should be cautioned to consult a doctor or pharmacist before using this product if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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 right away, regardless of whether signs or symptoms are present.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, 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 that lasts may indicate a serious condition requiring prompt 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 24 hours, or if the product is used concurrently with other medications 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 applicable; 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 seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults, or if fever worsens or lasts more than three 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 lasting longer than expected may indicate a serious condition requiring medical evaluation.

Other adverse reactions noted include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients should exercise caution when driving or operating machinery.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 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 that excitability may occur, particularly in pediatric patients. If symptoms such as pain, nasal congestion, or cough worsen or persist for more than 5 days, it is important to discontinue use and consult a doctor. Additionally, caution is warranted regarding liver health; if a child takes more than 5 doses within a 24-hour period, medical advice should be sought.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The product contains acetaminophen, which poses a risk of severe liver damage if the dosage exceeds 4,000 mg within a 24-hour period.

Additionally, patients should be aware that the risk of liver damage is heightened if this product is taken concurrently with other medications containing acetaminophen. Furthermore, consumption of three or more alcoholic drinks daily while using this product may also increase the likelihood of severe liver damage.

Due to these risks, careful consideration and monitoring of liver function are advised for patients with compromised liver function when using this product.

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 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 adverse effects. Therefore, vigilance and timely medical evaluation are essential components of managing an overdose situation.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

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

Additionally, reports indicate that users should stop taking acetaminophen and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Other concerns warranting medical advice include worsening pain, nasal congestion, or cough lasting beyond 5 days in children or 7 days in adults, as well as fever persisting for more than 3 days. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may also indicate a serious condition requiring medical evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, 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 about the presence of acetaminophen in their medications, they should 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) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, or within two weeks of stopping an MAOI. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleepiness in children and should not use it if they have a history of allergic reactions to this product or any of its ingredients.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. They should also be informed to seek medical attention if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant 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 should be reminded to adhere strictly to the recommended dosage. They should be made aware that excitability may occur, especially in children, and that marked drowsiness is a possible side effect. Patients should avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be advised when driving or operating machinery.

Patients with specific health conditions should be encouraged to consult their healthcare provider before using this product. This includes individuals with liver disease, heart disease, glaucoma, thyroid disease, diabetes, high blood pressure, or those experiencing difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, or a persistent cough related to smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should consult 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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

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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