Mucus

Description

Guaifenesin Extended-Release Tablets, 600 mg, are formulated as an expectorant indicated for the relief of chest congestion. Each tablet contains the active ingredient guaifenesin, which functions by thinning and loosening mucus, thereby facilitating easier expectoration. The product is designed for both immediate and extended release, providing a duration of action of up to 12 hours. The packaging includes 20 extended-release tablets and is identified by NDC 46122-416-60. This formulation is comparable to the active ingredient found in Mucinex®† and is marketed under the GOOD NEIGHBOR PHARMACY® label.

Uses and Indications

This drug is indicated for the relief of chest congestion by helping to loosen phlegm (mucus) and thin bronchial secretions. It facilitates the clearance of bothersome mucus from the bronchial passageways, thereby making coughs more productive. The formulation is available in both immediate and extended-release forms to accommodate varying patient needs.

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

Dosage and Administration

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

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours. The total daily dosage should not exceed 4 tablets within a 24-hour period.

This medication 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

The use of this medication is contraindicated in children under 12 years of age.

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

Patients must be instructed to discontinue use and contact their healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of overdose situations.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated for children under 12 years of age.

Before using this medication, patients are advised to consult a healthcare professional if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice prior to use.

Patients are instructed to discontinue use and consult a healthcare provider if the 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 medical evaluation.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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 (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. Safety and efficacy have not been established in this age group, and use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients in this age range.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this medication is not recommended for use in children under 12 years of age. Patients should be counseled 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 a doctor before using the medication if they have a persistent or chronic cough 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 should ensure that the carton is not used if it is open or if the printed seal on the blister is broken or missing.

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

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 1 or 2 tablets every 12 hours, not to exceed 4 tablets in a 24-hour period. It is contraindicated for children under 12 years of age. Clinicians should advise patients not to crush, chew, or break the tablet and to take it with a full glass of water. The medication can be taken without regard to meal timing.

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

Drug Information (PDF)

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

View product document (PDF)