Topcare Nitetime 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 cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of 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 reaction to this product or any of its ingredients contraindicates its use.

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, 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 three 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 two 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 a history of liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to an enlarged prostate gland. Additionally, individuals with a persistent or chronic cough, as seen in smoking, asthma, or emphysema, should consult a healthcare provider before use. It is also recommended that patients inform their doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In cases of 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 right away, regardless of whether symptoms are present.

Patients should discontinue use and contact their healthcare provider if pain or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or persists beyond 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further 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 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, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or lasts beyond 5 days in children or 7 days in adults, if fever worsens or persists for more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, excessive mucus production, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, or persistent cough associated with smoking, asthma, or emphysema should seek medical advice. Additionally, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

In the event of an overdose, it is critical 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 initially apparent.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in patients who consume three or more alcoholic beverages daily. Clinicians should advise patients to avoid such combinations to mitigate the risk of hepatotoxicity.

Dextromethorphan is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. The combination may lead to serious interactions, and therefore, it is essential to ensure that patients are not on MAOIs before prescribing dextromethorphan.

When acetaminophen is administered alongside warfarin, it may influence warfarin levels, necessitating careful monitoring of the International Normalized Ratio (INR). Healthcare providers should consider adjusting the warfarin dosage based on INR results to maintain therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Nitetime Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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.

Caution is warranted as excitability may occur, particularly in children, and marked drowsiness has been reported. Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child's pain or cough worsens or persists beyond 5 days. For adults, the duration for seeking medical advice is 7 days.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 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 metabolism and clearance of the medication. Monitoring of liver function may be necessary to ensure safety and efficacy 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 proactive approach can significantly impact the outcome in such situations.

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 any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)