Cold Multi-Symptom Nighttime

Description

Marc’s® is a nighttime cold relief formulation indicated for adults, containing a combination of active ingredients: acetaminophen, dextromethorphan HBr, phenylephrine HCl, and chlorpheniramine maleate. This product serves multiple therapeutic purposes, functioning as a pain reliever and fever reducer, cough suppressant, nasal decongestant, and antihistamine. The product is available in a dosage form of 24 cool taste caplets, with an NDC of 68998-139-02.

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 to ensure proper absorption and efficacy. 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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

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

• Exceeding the recommended dosage is contraindicated to prevent potential toxicity.

• Consumption of alcoholic beverages is not advised while using this product, as it may increase the risk of adverse effects.

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the maximum daily dose of 10 caplets (3,250 mg acetaminophen) within a 24-hour period. Severe 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, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance. Additionally, 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.

General precautions should be observed when using this product. It should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. The product should also not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. If there is uncertainty about whether a prescription drug contains an MAOI, it is essential to seek guidance from a healthcare professional.

Individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use. Prior to using this product, it is advisable to consult a doctor if the patient has 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 or chronic cough associated with smoking, asthma, or emphysema. Additionally, individuals with breathing problems such as emphysema or chronic bronchitis should seek medical advice before use.

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

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Users 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 develop; 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, 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 that associated with smoking, asthma, or emphysema, as well as those with breathing problems like emphysema or chronic bronchitis, should also consult a healthcare provider prior to use.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The use of alcohol, sedatives, or 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), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI.

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

Caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance the sedative effects, leading to increased drowsiness. The concurrent consumption of alcohol with this medication, as well as with sedatives and tranquilizers, may further exacerbate drowsiness and should be avoided.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Multi-Symptom 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 children aged 12 years and older, the recommended dosing 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

Elderly patients, defined as those aged 65 and older, do not have specific recommendations or dosage adjustments outlined in the provided prescribing information. While there are no explicit safety concerns or special precautions mentioned for this demographic, it is essential for healthcare providers to exercise caution.

It is advised that elderly patients consult their healthcare provider prior to use, particularly if they have underlying conditions such as liver disease, high blood pressure, diabetes, heart disease, thyroid disease, glaucoma, or difficulties with urination due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the treatment in geriatric patients, necessitating careful monitoring and consideration of individual patient factors.

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 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 necessitates careful consideration in this population. The maximum recommended daily dose is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period.

It is critical to note that exceeding 4,000 mg of acetaminophen in a 24-hour timeframe, whether through this product or in combination with other medications containing acetaminophen, may lead to severe liver damage. Additionally, consumption of three or more alcoholic beverages daily while using this product may further increase the risk of liver injury. Therefore, patients with compromised liver function should adhere strictly to the recommended dosage and be vigilant about potential interactions with other acetaminophen-containing products and alcohol consumption. Regular monitoring of liver function may be warranted in these patients 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 timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is crucial to remain vigilant and proactive in managing potential overdose cases to ensure patient safety and effective treatment.

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 manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients 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 consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are often prescribed for depression, psychiatric conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. They should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days, patients should seek medical advice. Any signs of redness or swelling, 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. Caution should be exercised 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 consult a doctor before using this product. Furthermore, patients with a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or those with breathing problems such as emphysema or chronic bronchitis should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should consult 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 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 the recommended dosage for adults and children aged 12 years and older being 2 caplets every 4 hours. Patients should swallow the caplets whole, avoiding crushing, chewing, or dissolving them, and must not exceed 10 caplets within a 24-hour period. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)