Cold Max Nighttime

Description

Careone® COLD MAX NIGHTTIME is a combination medication formulated for the relief of multiple symptoms associated with colds and flu. Each caplet contains acetaminophen, a pain reliever and fever reducer, dextromethorphan HBr, a cough suppressant, phenylephrine HCl, a nasal decongestant, and chlorpheniramine maleate, an antihistamine. This product is indicated for the relief of head and body aches, fever, sore throat, cough, nasal congestion, and runny nose. It is intended for use by adults and is available in a package containing 24 caplets with a cool taste. The National Drug Code (NDC) for this product is 72476-239-02.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu 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 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 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 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 this product in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause 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.

In instances of severe sore throat that 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 must be observed. This product should not be used concurrently 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. Additionally, this product should 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. Furthermore, individuals with a history of allergic reactions to this product or any of its ingredients should refrain from use.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is necessary. Timely medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Users should discontinue use and consult a healthcare provider if any of the following occur: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists for 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. These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this product, which can be categorized by seriousness and frequency.

Severe liver damage is a significant concern associated with the use of acetaminophen. This risk is heightened if patients 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.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Patients experiencing any of these symptoms should discontinue use immediately and seek medical assistance.

In cases of sore throat, patients are advised to consult a doctor if the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Patients should stop using the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache that persists are also indicators that a serious condition may be present, warranting prompt medical evaluation.

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 for depression, psychiatric conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 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. It is recommended that patients seek guidance from a healthcare provider before concurrent use of these agents. Furthermore, the consumption of alcohol in conjunction with this medication, as well as with sedatives and tranquilizers, may also exacerbate drowsiness.

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. There is a potential for excitability, particularly in children, and marked drowsiness may also occur. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 4 hours. Specific dosing recommendations for children under 12 years require consultation with a doctor.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 exercise caution when using this product, which contains acetaminophen. The maximum daily dose 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 patients exceed 4,000 mg of acetaminophen in 24 hours, use 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 specific liver function status. 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, vigilance and timely action are essential in managing overdose situations effectively.

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: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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. They should also be aware that redness or swelling, new symptoms, or a cough that returns or occurs with a rash or headache warrants immediate 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 informed 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 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 important to retain the carton for reference to complete product information.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to take 2 caplets every 4 hours, ensuring that they swallow the caplets whole without crushing, chewing, or dissolving them. 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 administration.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children to prevent accidental ingestion. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.

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