Guaifenesin

Description

Guaifenesin is an expectorant available in tablet form, with a strength of 200 mg per tablet. It is indicated for the relief of chest congestion and works by thinning and loosening mucus. Each package contains 100 tablets. The product features a tamper-evident seal; it should not be used if the imprinted safety seal under the cap is broken or missing. Guaifenesin is distributed by MAJOR® PHARMACEUTICALS, located in Indianapolis, IN 46268, and can be contacted at (800) 616-2471. Additional information is available on the website www.major-rugby.com. The revision date for this information is April 25, M-17, with a reorder number of 238163.

Uses and Indications

This drug is indicated for the relief of chest congestion and to assist in the loosening of phlegm (mucus) and thinning of bronchial secretions. By facilitating the clearance of bothersome mucus, this medication enhances the productivity of coughs, thereby aiding in the management of respiratory conditions characterized by excessive mucus production.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 1 to 2 tablets every 4 hours as needed. For children aged 6 to under 12 years, the dosage is ½ to 1 tablet every 4 hours. For children under 6 years of age, it is advised to consult a physician for appropriate dosing.

It is important to note that the maximum dosage should not exceed 6 doses within a 24-hour period. The tablets should be taken with a full glass of water to ensure proper administration and absorption.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than 7 days, tends to recur, 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 essential for healthcare professionals to be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use if they present with a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, which may be indicative of underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In instances where a cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, patients should discontinue use and seek medical advice. These symptoms may signify a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is critical to obtain emergency medical assistance immediately or contact a Poison Control Center for guidance.

General precautions should be taken into account; specifically, individuals who are pregnant or breastfeeding should consult a healthcare professional before using this medication to ensure safety for both the mother and child.

Lastly, it is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, tends to recur, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should seek medical advice before using this medication if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may occur in conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

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 Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and over may be administered 1 to 2 tablets every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is ½ to 1 tablet every 4 hours. It is advised that parents or caregivers consult a doctor before using this medication in children under 6 years of age.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 medication 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 regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly in accordance with established medical protocols.

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 provided in the insert 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 7 days, 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 packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines based on age. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours. For children aged 6 to under 12 years, the dosage is ½ to 1 tablet every 4 hours. For children under 6 years, it is advised to consult a doctor for appropriate dosing.

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

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)