Topcare Day Time Nite Time Cold and Flu

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 nasal congestion, sinus congestion and pressure, minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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 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 as needed.

For children aged 4 years to under 12 years, it is advised to consult a healthcare professional 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, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in 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 also contain acetaminophen, or consuming three or more alcoholic drinks daily while taking this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients must 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.

Healthcare professionals should recommend that patients consult a doctor prior to use 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, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or if they are on a sodium-restricted diet.

Additionally, patients should be cautioned to seek advice from a doctor or pharmacist before using this product 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 (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients must be advised to discontinue use and contact a 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 or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 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 a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional 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 persists beyond three days, or if new symptoms arise. The presence of redness or swelling, or a cough that recurs or occurs with a rash or headache lasting for an extended period, may indicate a serious condition requiring medical evaluation.

When using this product, patients should adhere strictly to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness is a common side effect. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues should consult a doctor before use. Additionally, those experiencing persistent coughs, especially those associated with excessive phlegm, or who have difficulty urinating due to an enlarged prostate gland, should seek medical advice prior to using this product.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a healthcare professional before use. In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are apparent. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for assistance.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other medications 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 advised to avoid the use of dextromethorphan in patients currently taking MAOIs or within two weeks of discontinuing them.

Warfarin, an anticoagulant, may experience altered effects when administered alongside acetaminophen or dextromethorphan. Therefore, monitoring of International Normalized Ratio (INR) levels may be necessary to ensure safe and effective anticoagulation therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Day Time Nite Time Cold and Flu (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 aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In contrast, children aged 4 to under 6 years should also seek guidance from a doctor regarding dosing. It is important to note that the product is not recommended for use in children under 4 years of age.

In terms of safety, excitability may occur, particularly in pediatric patients. Additionally, an overdose poses a significant risk; prompt medical attention is essential for both children and adults, even in the absence of noticeable signs or symptoms. For patients aged 12 years and older, the dosage is 30 mL every 4 hours.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, due to the increased likelihood of comorbidities and the potential for adverse effects. It is advisable 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, glaucoma, or a history of respiratory issues such as emphysema or chronic bronchitis. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, persistent cough associated with smoking, asthma, or emphysema, or who are on a sodium-restricted diet should seek medical advice.

Elderly patients taking sedatives, tranquilizers, or the anticoagulant warfarin should also consult a healthcare professional or pharmacist before using this product, as interactions may increase the risk of adverse effects.

When using this product, it is crucial for geriatric patients to adhere strictly to the recommended dosage, as exceeding the directed amount may lead to marked drowsiness. Patients should avoid alcoholic beverages, as the combination of alcohol with this product, along with sedatives and tranquilizers, may further enhance drowsiness. Caution is advised when driving or operating machinery due to the potential for impaired alertness.

Elderly patients are encouraged to discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Patients should also report any redness or swelling, the emergence of new symptoms, or if a cough recurs or is accompanied by a rash or headache that lasts.

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 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 difficulties with urination 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, 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 this medication.

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.

Acetaminophen has been associated with 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. Additionally, it is recommended to stop use and consult a physician if any of the following occur: increased nervousness, dizziness, or sleeplessness; worsening or persistent pain, nasal congestion, or cough lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

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

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, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage. It is important to inform them that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Providers should caution patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

When discussing safety, healthcare providers should remind patients to exercise caution when driving or operating machinery due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough that produces excessive phlegm. Additionally, patients with breathing problems such as emphysema or chronic bronchitis, those experiencing difficulty urinating due to an enlarged prostate gland, or individuals 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 should consult their healthcare provider before use. It is also advisable for patients to speak with their doctor or pharmacist if they are currently taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin.

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

Patients aged 12 years and older are advised to administer 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours, while for those aged 4 to under 6 years, it is recommended to consult a doctor. The product is not intended for use in 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 the Poison Control Center contacted 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 Day Time Nite Time Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)