Mucus Relief Max

Description

Guaifenesin Extended-Release 1200 mg Tablets are formulated as a maximum strength expectorant, indicated for the relief of chest congestion. Each tablet contains 1200 mg of guaifenesin, which functions to thin and loosen mucus, facilitating easier expectoration. The product is packaged in a bottle containing 14 extended-release tablets. This formulation is comparable to the active ingredient in Mucinex® Extended Release 1200 mg Tablets, with the National Drug Code (NDC) 53943-234-07 assigned to this product.

Uses and Indications

This drug is indicated for the relief of chest congestion and the facilitation of productive coughs by loosening phlegm (mucus) and thinning bronchial secretions. It aids in clearing the bronchial passageways of bothersome mucus, thereby enhancing respiratory function.

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

Dosage and Administration

Patients should take the tablet with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken prior to administration. This product can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours. The total daily dosage should not exceed 2 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may include a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms could indicate a serious underlying illness.

In addition to serious reactions, patients may experience persistent or chronic cough, which can occur in individuals with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, a cough accompanied by excessive phlegm (mucus) has also been noted as a potential adverse reaction. It is important for patients to monitor their symptoms and seek medical attention if they experience any of these concerning signs.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Max (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children under 12.

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 efficacy, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. 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 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 may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated phone number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals are advised not to use the product if the carton is open or if the printed seal on the blister is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours for adults and children aged 12 years and older, not to exceed two tablets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)