Guaifenesin Extended-Release 1200 mg, Guaifenesin Extended-Release 600 mg

Description

GUARDIAN is an extended-release formulation containing Guaifenesin as the active ingredient. Each tablet has a strength of 600 mg and is designed to be taken every 12 hours. This expectorant is indicated for the relief of chest congestion by thinning and loosening mucus. The product is available in a package containing 20 extended-release tablets. The National Drug Code (NDC) for this product is 53041-233-32.

Uses and Indications

This drug is indicated for the relief of chest congestion by helping to loosen phlegm (mucus) and thin bronchial secretions. It facilitates the clearance of bothersome mucus from the bronchial passageways, thereby making coughs more productive.

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 maximum allowable 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

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to ensure patient safety and effective management of the situation.

Healthcare professionals should advise patients to discontinue use and consult a physician if a cough 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 further evaluation and intervention.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to note that a cough lasting more than 7 days, or a cough that recurs, particularly when accompanied by fever, rash, or persistent headache, may indicate a serious underlying illness and should be evaluated by a healthcare professional.

In addition to the aforementioned serious warnings, patients may also experience persistent or chronic cough, which can occur in individuals with pre-existing conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, a cough that is accompanied by excessive phlegm (mucus) has also been reported.

Healthcare providers should monitor patients for these adverse reactions and consider the clinical context when evaluating symptoms.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin Extended-Release 1200 mg, Guaifenesin Extended-Release 600 mg (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

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the prescribing information. The insert does not provide any recommendations regarding age considerations or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential risks associated with their age. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

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 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 may require dosage adjustments based on their level of kidney function. It is essential to monitor renal function tests regularly in these patients to ensure safe and effective treatment. A reduced dose may be necessary for patients with a creatinine clearance below a certain threshold. Special considerations should be taken into account for patients with severe renal impairment to avoid potential toxicity.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments. It is recommended that these patients undergo special monitoring of liver function tests to assess their condition and response to therapy. For patients with severe hepatic impairment, a reduced dose may be required, or alternative therapy should be considered to ensure safety and efficacy.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution when administering the medication.

Should an overdosage occur, it is essential to monitor the patient closely for any potential symptoms that may arise, although these symptoms are not explicitly detailed in the current documentation.

Management of an overdosage should be guided by standard medical practices, including supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to consult local poison control centers or relevant medical authorities for further guidance on managing suspected overdosage cases.

In summary, due to the lack of detailed overdosage information, vigilance and adherence to established medical protocols are paramount in ensuring patient safety.

Nonclinical Toxicology

No specific teratogenic effects have been identified in the studies conducted. Similarly, there are no reported non-teratogenic effects associated with the substance. The available data do not provide any specific insights into nonclinical toxicology, nor are there details regarding animal pharmacology and toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated contact number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed 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 tamper-evident packaging. Healthcare professionals should ensure that the carton is not used if it is open or if the printed seal on the blister is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Proper adherence to these storage guidelines is essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for adults and children aged 12 years and older. Patients are advised to take 1 or 2 tablets every 12 hours, ensuring not to exceed 4 tablets (600 mg) in a 24-hour period or 2 tablets (1200 mg) in a 24-hour period, depending on the prescribed dosage.

Clinicians should counsel patients to avoid crushing, chewing, or breaking the tablet and to take it with a full glass of water. The medication can be taken without regard to meal timing. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin Extended-Release 1200 mg, Guaifenesin Extended-Release 600 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)