Guaifenesin 1200 mg, Guaifenesin 600 mg

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, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucociliary clearance, this medication makes coughs more productive, thereby alleviating symptoms associated with respiratory conditions characterized by mucus accumulation.

Limitations of Use: This drug is not intended for the treatment of chronic cough due to smoking, asthma, or emphysema. It should be used with caution in patients with a history of respiratory conditions that may be exacerbated by increased mucus clearance.

Dosage and Administration

Patients should take the extended-release tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to ingestion. 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 extended-release tablets may be taken every 12 hours, with a maximum of 4 extended-release tablets in a 24-hour period.

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

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

Contraindications

Use of this product is contraindicated in children under 12 years of age.

Warnings and Precautions

Applicable warnings as outlined in 201.66(c)(5)(i) and (ii) must be adhered to when considering the use of this medication.

This medication is contraindicated for use in children under 12 years of age. Healthcare professionals should advise against its administration in this population to prevent potential adverse effects.

Prior to prescribing this medication, it is essential to consult a physician if the patient has a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought before use.

Patients should be instructed to discontinue use and consult a healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay to ensure appropriate management.

Side Effects

Patients should be advised to stop use and consult a healthcare professional if a 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 underlying illness.

Additionally, patients are encouraged to seek medical advice before using the product if they have a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. It is also important to consult a healthcare provider if the cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 1200 mg, Guaifenesin 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning 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 phone 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 children under 12 years of age.

Patients should be counseled to monitor their cough symptoms closely. If a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, they should be instructed to seek medical attention, as these may indicate a serious underlying condition. Additionally, patients with a persistent or chronic cough, particularly those related to smoking, asthma, chronic bronchitis, or emphysema, should be made aware that this medication may not be appropriate for their situation.

Furthermore, patients should be informed that a cough accompanied by excessive phlegm (mucus) warrants a discussion with their healthcare provider, as it may require further evaluation and management.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

For adults and children aged 12 years and older, the recommended administration of the extended-release tablets is as follows: for the 600 mg formulation, patients should take 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. For the 1200 mg formulation, the dosage is 1 extended-release tablet every 12 hours, not to exceed 2 tablets in a 24-hour period. 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 1200 mg, Guaifenesin 600 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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