Guaifenesin

Description

Guaifenesin is a mucolytic agent with a dosage strength of 1200 mg. It is utilized to facilitate the clearance of mucus from the airways, thereby aiding in the relief of chest congestion. The compound is characterized by its chemical formula, which is C10H14O4S, and it has a molecular weight of 230.28 g/mol. Guaifenesin is typically presented in a dosage form suitable for oral administration.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing 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 and must not crush, chew, or break them. 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 as follows:

• For the 600 mg formulation: 1 or 2 tablets may be taken every 12 hours, with a maximum of 4 tablets in a 24-hour period.

• For the 1200 mg formulation: 1 tablet may be taken every 12 hours, with a maximum of 2 tablets in a 24-hour period.

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

Contraindications

Use is contraindicated in patients with a cough that 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.

Warnings and Precautions

Use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not prescribed to this age group to avoid potential adverse effects.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and intervention. Regular monitoring of these symptoms is essential to ensure patient safety and appropriate management.

Side Effects

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

In clinical practice, patients are advised to stop using the medication and consult a healthcare professional if their 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.

Additionally, patients should seek medical advice before using this medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Coughs accompanied by excessive phlegm (mucus) also warrant consultation with a healthcare provider prior to use.

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 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. Healthcare professionals are advised to consider alternative treatments for pediatric patients within 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 should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

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 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 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 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 are advised to ensure that patients or caregivers are aware of the importance of rapid response in such situations.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

It is important for patients to consult with their healthcare provider prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema.

Additionally, patients should be encouraged to seek medical advice before using the product if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to inspect the carton before use; do not utilize 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 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

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 of 4 tablets in a 24-hour period for the 600 mg formulation. For the 1200 mg formulation, the dosage is 1 tablet every 12 hours, not to exceed 2 tablets in 24 hours. The medication is not recommended for use in children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)