Mucus Relief

Description

Guaifenesin is an expectorant formulated to relieve chest congestion by thinning and loosening mucus. Each tablet contains 400 mg of guaifenesin. The product is packaged in a bottle containing 30 tablets. It is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. The National Drug Code (NDC) for this product is 0363-0532-01. It is distributed by Walgreen Co., located in Deerfield, IL 60015.

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.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 hours as needed. It is imperative that they do not exceed a total of 6 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should ensure that patients adhere strictly to the prescribed dosage and frequency to avoid potential overdose.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician prior to using this medication if they present with a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and seek medical advice if their cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

Additionally, it is crucial to emphasize the importance of keeping this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to stop use and consult a healthcare professional if a cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Before using this medication, patients should seek medical advice if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin). 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 aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

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 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. 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 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored throughout the treatment process. It is advisable to follow established protocols for overdose management, which may include administering activated charcoal if appropriate and ensuring the patient’s safety during the recovery phase.

In summary, immediate action and appropriate medical intervention are critical in the case of an overdose to ensure the best possible outcome for the patient.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of the medication; they should stop use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to using the medication if they are experiencing a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. This precaution is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. Use is not recommended for children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)