Mucus Relief Severe Cold

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, nasal congestion, minor aches and pains, sore throat, and headache. It also temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion 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 6 doses within a 24-hour period. It is imperative to measure the dose using only the dosing cup provided with the product; the use of any other dosing device is not advised. The dosing cup should be kept with the product for convenience.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours, as needed. For children under 12 years of age, the product is not indicated and should not be used.

Healthcare professionals are reminded to counsel patients on the importance of not exceeding the directed dosage and to refer to the Overdose warning for further information.

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.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson's disease, and their interaction with this product may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• Use should not exceed the recommended dosage.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, heart disease, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should discontinue use and contact their 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 develop; or if a cough recurs with fever, rash, or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur 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 beverages daily while using this product. Patients should be aware of the potential for severe skin reactions, which may 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.

Patients are advised to consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs with fever, rash, or headache warrant prompt medical evaluation, as these may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or urinary difficulties due to an enlarged prostate gland should consult a doctor prior to use. Those with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as coughs accompanied by excessive phlegm, should also seek medical advice before using this product. Furthermore, individuals taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before use.

An overdose warning is in place, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Severe Cold (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 patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. Safety and efficacy have not been established in children younger than 12 years, and therefore, use in this population is contraindicated.

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 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 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 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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit may lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, which may occur when the recommended dosage is exceeded. Healthcare professionals should advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. The lack of immediate symptoms does not preclude the risk of significant harm, underscoring the importance of vigilance and proactive management in cases of suspected overdose.

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 several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to adhere strictly to the recommended dosage, as taking more than directed may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed not to exceed the directed dosage. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical guidance if they have a cough that produces excessive phlegm (mucus).

Furthermore, it is important for healthcare providers to remind patients to consult with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied with a dosing cup included in the package. It should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated.

To ensure safety and integrity, the product features a tamper-evident seal. It is imperative not to use the product if the printed safety seal around or under the cap is broken or missing.

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

View product document (PDF)