Cold Plus Head Congestion Nighttime

Description

TopCare® Health NIGHTTIME Cold + Head Congestion Nighttime is formulated to provide relief from multiple symptoms associated with colds and allergies. Each caplet contains a combination of active ingredients: acetaminophen, dextromethorphan HBr, phenylephrine HCl, and chlorpheniramine maleate. This formulation serves as a pain reliever and fever reducer, cough suppressant, nasal decongestant, and antihistamine.

The product is designed to alleviate symptoms including headache, body aches, fever, sore throat, cough, nasal congestion, and runny nose. It is available in a dosage form of 24 cool taste caplets, ensuring ease of administration. The National Drug Code (NDC) for this product is 36800-925-02.

Uses and Indications

This drug is indicated for the temporary relief of cold symptoms, including minor aches and pains, headache, sore throat, nasal congestion, runny nose, sneezing, cough, and sinus congestion and pressure. It aids in clearing nasal passages and provides cough relief to facilitate sleep. Additionally, this drug temporarily reduces fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the maximum dosage should not exceed 10 caplets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

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 interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe adverse effects.

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the recommended dosage to prevent severe liver damage. The maximum daily dose is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. Liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any skin reaction occur, 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 is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, high blood pressure, heart disease, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), a breathing problem (such as emphysema or chronic bronchitis), or glaucoma. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking blood-thinning medications such as warfarin or sedatives/tranquilizers.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult 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 is observed; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur 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 may experience 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 and seek medical assistance immediately.

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 professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. A history of allergic reactions to this product or any of its ingredients also contraindicates its use.

Patients with liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should seek medical advice before using this product. Those with a cough that produces excessive phlegm, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or breathing problems like emphysema or chronic bronchitis should also consult a healthcare provider. Individuals with glaucoma should ask a doctor before use.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist prior to using this product.

While using this product, patients should adhere to the recommended dosage to avoid potential adverse effects. Excitability may occur, particularly in children, and marked drowsiness is a possible side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor 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 arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

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

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Plus Head Congestion Nighttime (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are present.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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. 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 product. The formulation contains acetaminophen, which has specific dosing considerations for individuals with compromised liver function.

The maximum recommended daily dose of this product is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if the total acetaminophen intake exceeds 4,000 mg in a 24-hour period. Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage when using this product. Therefore, careful monitoring and adherence to the recommended dosage are essential for patients with hepatic impairment to mitigate the risk of adverse effects.

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 essential 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, it is crucial to monitor the patient closely and provide appropriate medical care as needed.

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

Postmarketing experience has identified the following adverse reactions associated with acetaminophen. Reports of severe skin reactions have been documented, which include symptoms such as skin reddening, blisters, and rash. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 whether a medication contains acetaminophen, they should be encouraged to 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 advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a cough that returns or occurs with a rash or headache should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, so patients should be advised to avoid alcoholic beverages while using this product. Caution should be exercised when driving or operating machinery.

Patients with liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should be encouraged to consult a doctor before using this product. Additionally, patients should seek medical advice if they have a cough accompanied by excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they have breathing problems such as emphysema or chronic bronchitis. Patients with glaucoma should also consult their healthcare provider prior to use. Lastly, those taking the blood-thinning medication warfarin or any sedatives or tranquilizers should be advised to speak with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product details.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. It is important to swallow the caplets whole and not to crush, chew, or dissolve them. For children under 12 years, a healthcare professional should be consulted for appropriate dosing.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before using the medication. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Cold Plus Head Congestion Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)