Guaifenesin 400mg

Description

Guaifenesin is presented in a dosage form of 400 mg per caplet. Each bottle contains 30 caplets. The National Drug Code (NDC) for this formulation is 10135-0682-30.

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 passageway.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 1 to 2 tablets administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

This product is contraindicated for use in children under 12 years of age. Healthcare professionals should ensure that patients are aware of this restriction to prevent inappropriate use.

Contraindications

Use is contraindicated if the imprinted safety seal under the cap is broken or missing, as this indicates potential tampering and compromises product integrity.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician prior to use if they exhibit any of the following conditions: persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Patients are instructed to discontinue use and consult a healthcare provider if their 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 the presence of a serious underlying condition that requires further evaluation.

In the event of an overdose, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice.

It is important for patients to discontinue use and consult a doctor if their 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 the presence of a serious underlying illness that requires further evaluation.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 400mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. Caution should be exercised when considering the use of this product in younger populations, as safety and efficacy have not been established in children under 12 years.

Geriatric Use

Elderly patients may utilize this product; however, it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to monitor elderly patients closely for any adverse effects or changes in therapeutic response, and to consider potential dose adjustments based on individual patient factors, including renal and hepatic function.

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 regarding 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 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 should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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, returns after improvement, 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 emphasize the importance of product integrity. Patients must be informed that the medication should not be used if the tamper-evident safety seal under the cap is broken or missing, as this could compromise the safety and efficacy of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should store the medication at a temperature range of 15°C to 30°C (59°F to 86°F) to ensure its efficacy and stability. Clinicians should advise patients to adhere to these storage conditions.

Drug Information (PDF)

This file contains official product information for Guaifenesin 400mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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