Guaifenesin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating more productive coughs.

There are no teratogenic or nonteratogenic effects associated with this drug, indicating its safety profile in these contexts.

Dosage and Administration

The recommended dosage for the medication should be adhered to as outlined below or as directed by a physician. It is imperative that no more than 6 doses are administered within a 24-hour period.

For adults and children aged 12 years and older, the dosage is 10 to 20 mL (equivalent to 2 to 4 teaspoonfuls), to be taken every 4 hours.

For children aged 6 years to under 12 years, the dosage is 5 to 10 mL (equivalent to 1 to 2 teaspoonfuls), also to be administered every 4 hours.

For children aged 2 to under 6 years, the recommended dosage is 2.5 to 5 mL (equivalent to ½ to 1 teaspoonful), to be given every 4 hours.

For children under 2 years of age, it is essential to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with hypersensitivity to any of its ingredients.

Additionally, if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, discontinuation of use is advised, and a healthcare professional should be consulted, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. It is imperative to advise patients to consult a physician prior to use if they present with a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition. Additionally, individuals with known hypersensitivity to any of the product's ingredients should refrain from use and consult a healthcare provider.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Currently, there are no specific laboratory tests recommended for the safe use of this product.

Side Effects

Patients should discontinue use and consult a healthcare professional if a 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, individuals who are hypersensitive to any of the ingredients should refrain from using the product.

Before initiating use, patients are advised to seek medical advice if they experience a cough associated with excessive phlegm (mucus) or if they have a chronic cough, which may be related to smoking, asthma, chronic bronchitis, or emphysema.

Drug Interactions

Guaifenesin may interfere with certain clinical laboratory determinations, specifically producing a color interference with the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). This interference could potentially lead to inaccurate laboratory results, which should be taken into consideration when interpreting test outcomes.

No additional drug interactions or laboratory test interactions have been reported for guaifenesin. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on the available data.

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 6 years to under 12 years may receive 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours. For infants and children under 2 years of age, consultation with a physician is advised prior to administration.

It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center.

Healthcare professionals should note that guaifenesin may interfere with certain clinical laboratory determinations, specifically those measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

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 the safety of both the mother and the developing fetus.

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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and individualized patient assessment. 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 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 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 and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

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 or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, patients should be cautioned to stop use and seek medical advice if they experience hypersensitivity to any of the ingredients in the medication.

It is important for healthcare providers to recommend that patients consult a doctor before using the medication if they have a cough that occurs with excessive phlegm (mucus). Furthermore, patients should be advised to seek medical guidance if they have a cough that is chronic or lasts for an extended period, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a tightly closed container to ensure integrity. It should be stored at a controlled room temperature, specifically between 20°-25°C (68°-77°F). Additionally, it is essential to protect the product from light to maintain its efficacy and stability.

Additional Clinical Information

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations, specifically affecting the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Clinicians should be aware of this potential interference when interpreting laboratory results in patients receiving guaifenesin.

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)