Topcare Day Time Nite Time Cold and Flu Relief

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 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 associated with this drug.

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The provided dose cup must be used for accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to 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, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while taking this product.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, 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 when considering the use of this product. Patients should be encouraged to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, breathing problems such as emphysema or chronic bronchitis, a persistent cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare professional if any of the following occur: worsening pain or cough lasting more than seven days, fever worsening or lasting more than three days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by 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 taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, 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 be cautious of excitability, particularly in children, and marked drowsiness may occur. It is 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 are advised to stop use and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, a breathing problem such as emphysema or chronic bronchitis, a persistent cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, it is recommended to seek advice from a healthcare professional if taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other products containing acetaminophen or in individuals consuming three or more alcoholic beverages daily.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious side effects. It is recommended to avoid the use of dextromethorphan in conjunction with MAOIs or for a period of two weeks following the discontinuation of MAOIs.

Warfarin, an anticoagulant, may experience altered effects when administered with acetaminophen or dextromethorphan. Therefore, close monitoring of INR levels is advised to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Day Time Nite Time Cold and Flu Relief (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 require specific dosing instructions from a healthcare professional. For children under 4 years, the product is contraindicated and should not be used.

In the context of nighttime cold and flu treatment, the recommended dosage for adults and children aged 12 years and older is 30 mL every 6 hours. For daytime cold and flu, adults and children aged 12 years and older should take 30 mL every 4 hours, while children aged 6 to under 12 years may take 15 mL every 4 hours. Children aged 4 to under 6 years should also seek dosing guidance from a healthcare provider, and again, the product is not suitable for children under 4 years.

It is important to note that excitability may occur, particularly in pediatric patients. In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older. It is essential for geriatric patients to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, patients with a cough that produces excessive phlegm or those experiencing a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this product.

Elderly patients who are taking the anticoagulant warfarin should also consult a healthcare provider or pharmacist prior to use, as interactions may occur. It is important to note that the use of this product may lead to marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Therefore, careful monitoring and consideration of these factors are advised to ensure the safety and well-being of geriatric patients.

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 should consult a healthcare professional prior to use, particularly 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 degree of impairment.

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 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur with the use of this product, particularly in children. Additionally, marked drowsiness has been reported. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific nonclinical toxicology information is available in the insert. Furthermore, there is no detailed animal pharmacology and toxicology information provided.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, there is a warning regarding the risk of overdose. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical intervention is essential for both adults and children, even if no signs or symptoms are apparent.

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 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) or have stopped taking an MAOI 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. They should also be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be informed to seek medical advice if their cough returns or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Patients should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate gland, or any breathing problems such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough related to smoking, asthma, or emphysema should also seek medical advice prior to use. Furthermore, patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be encouraged to discuss their situation with a healthcare professional 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

Patients aged 12 years and older are advised to take 30 mL of the medication every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours for daytime cold and flu relief.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted 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 Day Time Nite Time Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)