Cold Max Nighttime

Description

TopCare® Health Cold Max Nighttime is a combination medication formulated for the relief of multiple symptoms associated with colds and allergies. Each dosage form contains acetaminophen, dextromethorphan HBr, phenylephrine HCl, and chlorpheniramine maleate, providing pain relief, fever reduction, cough suppression, nasal decongestion, and antihistamine effects. The product is intended for adult use and is available in a package containing 24 cool taste caplets. The National Drug Code (NDC) for this product is 36800-914-02.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, 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. 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 allergic responses.

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 of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance. Additionally, if a sore throat is severe, persists beyond two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should exercise caution and advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, high blood pressure, diabetes, heart disease, thyroid disease, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent cough associated with smoking, asthma, or emphysema. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if they are taking blood-thinning medications such as warfarin or sedatives and 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 without delay, as timely intervention is critical for both adults and children, even in the absence of noticeable 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 occurs; 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 underlying condition that requires further 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 doctor 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, diabetes, heart disease, thyroid disease, glaucoma, or those experiencing trouble urinating due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, as well as those with breathing problems like emphysema or chronic bronchitis, should also consult a healthcare professional prior to use.

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

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Excitability may occur, particularly in children, and marked drowsiness has been reported. 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 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.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately (1-800-222-1222). Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. This combination 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 due to potential interactions.

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 Max 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, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 exercise caution when using this product, which contains acetaminophen. The maximum daily dose is limited to 10 caplets (3,250 mg of acetaminophen) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product based on their liver function. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

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 health consequences. Therefore, it is essential 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. These events have been 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 and to exercise caution when driving or operating machinery.

Patients with liver disease, high blood pressure, diabetes, heart disease, thyroid disease, glaucoma, or those experiencing difficulty urinating due to an enlarged prostate gland should be encouraged to consult a doctor before using this product. Furthermore, 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. Lastly, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should also consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It is important to store the product in a dry place at a temperature range of 20-25°C (68°-77°F) to ensure its stability and efficacy. The carton should be retained for reference to complete product information and any relevant warnings.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older should take 2 caplets every 4 hours, ensuring they are swallowed whole without crushing, chewing, or dissolving. The maximum dosage should not exceed 10 caplets within a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

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 contact a Poison Control Center 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 Cold Max Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)