Cold Max

Description

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl are the active ingredients in this formulation, which serves multiple therapeutic purposes, including pain relief, fever reduction, cough suppression, and nasal decongestion. The product is presented in the form of 24 caplets, designed for ease of administration.

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, cough, and sinus congestion and pressure. It aids in clearing nasal passages and promotes nasal and sinus drainage. 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 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. Verification of MAOI status with a healthcare provider is recommended if there is any doubt.

• History of allergic reaction 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, concomitant use with other medications containing acetaminophen, or consumption of 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. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should consult a doctor or pharmacist before use if they are taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening 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. These symptoms may indicate a serious condition requiring 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 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, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, or those experiencing coughs with excessive phlegm should also consult a healthcare provider prior to use.

Patients taking the blood-thinning medication warfarin should ask a doctor or pharmacist before using this product. It is crucial that patients do not exceed the recommended dosage while using this product.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists for more than 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 condition.

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

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Max (acetaminophen, 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 dosing is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, 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. 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 no specific data available regarding the excretion of this medication in 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.

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 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 adverse effects. Therefore, vigilance and timely medical evaluation are essential components of managing an overdose situation.

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 compound in these areas.

Postmarketing Experience

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

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 recurrence of cough, especially if accompanied by a rash or persistent headache, should also prompt patients to seek medical attention, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is essential for patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

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. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

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 Cold Max, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)