Mucus Relief Cold Flu and Sore Throat

Description

This formulation contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, designed for individuals aged 12 years and older. It is distributed by CDMA Inc., located at 43157 W. Nine Mile, Novi, MI 48376-0995. The product is subject to tamper evidence; it should not be used if the printed safety seal around or under the cap is broken or missing. This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Cold Flu & Sore Throat. For inquiries, contact 248-449-9300 or visit qualitychoice.com.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sinus congestion and pressure, minor aches and pains, nasal congestion, cough due to minor throat and bronchial irritation, sore throat, and headache. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The formulation aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits, and caution is advised to prevent overdose.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that the dosing cup is used exclusively for this product and not with any other medications.

For children under 12 years of age, the use of this product is not recommended.

Patients should not exceed 6 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. Due to the potential for serious interactions, it is advised to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is any doubt about the acetaminophen content of a medication, consultation with a healthcare professional is recommended.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at increased risk.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as timely intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Healthcare providers should advise patients to discontinue use and seek medical advice if any of the following occur: redness or swelling, nervousness, dizziness, or sleeplessness, the emergence of new symptoms, worsening pain, nasal congestion, or cough lasting more than 7 days, fever worsening or persisting beyond 3 days, or a cough that recurs or is accompanied by a rash or persistent headache. These signs may indicate a serious condition that necessitates further medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, particularly those containing acetaminophen.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. These reactions necessitate immediate medical attention. Additionally, there is a significant risk of severe liver damage, particularly if patients exceed six doses within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be vigilant for symptoms indicating a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Other symptoms that warrant medical consultation include the presence of redness or swelling, nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days. Additionally, if fever worsens or lasts more than three days, or if a cough recurs with a rash or persistent headache, patients should seek medical advice.

In the event of an overdose, which may lead to liver damage, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for conditions such as depression, psychiatric disorders, or Parkinson's disease.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Cold Flu and Sore Throat (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents and adults aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under 12 years.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 the safety of both the mother and the fetus or 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to use. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at risk for liver damage. Immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) should be made without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of the medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as the risk of liver damage can escalate rapidly.

It is important to note that prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early recognition and management can significantly improve outcomes in cases of suspected overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

It is important to inform patients that this product is not intended for use in children under 12 years of age. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is any doubt regarding the presence of acetaminophen in other medications, patients should seek guidance from a healthcare professional.

Healthcare providers should advise patients to discontinue use and consult a doctor if they experience redness or swelling, nervousness, dizziness, or sleeplessness. Patients should also be informed to stop use and seek medical advice if new symptoms arise, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days. Furthermore, patients should be alerted to the need for medical consultation if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the directed dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: diabetes, liver disease, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough with excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident safety seal. It is essential to ensure that the safety seal around or under the cap is intact before use; do not use the product if the seal is broken or missing.

Storage conditions require the product to be maintained at a temperature range of 20º-25ºC (68º-77ºF). It is crucial to avoid refrigeration. Additionally, the product should be kept out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mucus Relief Cold Flu and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)