Mucus Relief

Description

Guaifenesin Extended-Release Tablets, 600 mg, are formulated as an expectorant under the NDC 81522-203-02. These tablets are designed to provide mucus relief by thinning and loosening mucus, thereby relieving chest congestion. The product features both immediate and extended-release properties, allowing for a duration of action of up to 12 hours. Each package contains 20 extended-release tablets, which are presented in their actual size for professional reference. This formulation is comparable to the active ingredient of Mucinex®.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions characterized by excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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 administration. This product can be taken without regard for 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 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

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 should 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, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication.

Warnings: The medication is contraindicated for use in children under 12 years of age. Patients are advised to consult a healthcare professional prior to use 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 before using this product.

Serious Adverse Reactions: 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, as these symptoms may indicate a serious underlying condition.

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

These precautions and recommendations are essential for ensuring patient safety and effective use of the medication.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 be administered this medication. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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

Patients with renal impairment have not been specifically addressed in the drug insert. 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 information when prescribing this medication to patients with renal impairment.

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 as a result of the 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 prior to use 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 a carton that contains essential information and warnings, which should be retained for reference. It is recommended to store the product at a temperature range of 20-25ºC (68-77ºF) to ensure optimal stability and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum limit of 4 tablets within a 24-hour period. 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)