Revasol Tussin

Description

No description information is available for the drug.

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 aiding in the removal of bothersome mucus from the bronchial passageways.

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 10 mL (equivalent to 2 teaspoonfuls) administered every 4 hours as needed. It is imperative that the total number of doses does not exceed 6 doses within a 24-hour period.

Prior to administration, the product must be shaken well to ensure proper mixing. The dosing cup provided with the product should be used exclusively for measuring the dose, and it is advised to keep the dosing cup with the product at all times to prevent dosing errors.

This formulation is not intended for use in children under 12 years of age.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may indicate an underlying serious condition that requires medical evaluation.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, caution is advised if the cough is accompanied by excessive phlegm (mucus).

It is imperative to keep this medication out of the reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare provider if the cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In cases of accidental overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional before use if there is a history of a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Patients are advised to discontinue use and seek medical advice if the cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

This product is not intended for use in pediatric patients. Specifically, it is contraindicated in children under 12 years of age. Healthcare professionals should exercise caution and ensure that this product is not administered to this age group.

Geriatric Use

Elderly patients may utilize this product; however, it is important to note that it is not intended for use in children. For adults and geriatric patients aged 12 years and older, the recommended dosage is 10 mL (2 teaspoonfuls) every 4 hours.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as age-related physiological changes may affect drug metabolism and clearance. Monitoring for efficacy and potential adverse effects is advised, particularly in this population. Adjustments to the dosing regimen may be necessary based on individual patient response and tolerance.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies as needed.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: nausea, vomiting, and gastrointestinal discomfort. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center.

Additionally, healthcare providers should counsel patients to discontinue use and consult a doctor if their cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. It is important to inform patients that a persistent cough may indicate a serious underlying condition that requires further evaluation.

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 room temperature, within the range of 15-30°C (59-86ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)